Best Package Integrity & Seal Integrity Testing Labs for Medical Devices

Q: What is package integrity testing and do I need a package integrity testing lab?

Package integrity testing (also called packaging integrity testing ) verifies that medical device packaging maintains its sterility barrier and protects the device throughout shelf-life and distribution [1] . Package integrity testing labs perform tests including visual inspection, dye penetration, bubble emission, and leak detection per ISO 11607-2 [1] . Package integrity testing is required for sterile medical devices to demonstrate the packaging maintains sterility [2] . When searching for ' package integrity testing ' or ' packaging integrity testing ' providers, verify the laboratory is accredited for ISO 11607 testing and has experience with your packaging type (pouches, trays, etc.).

Q: What is seal integrity testing and pouch seal integrity testing?

Seal integrity testing (including pouch seal integrity testing ) measures the strength and quality of seals in medical device packaging [1] . Seal integrity testing ensures that seals maintain their integrity throughout shelf-life and distribution, preventing contamination and maintaining sterility. Common seal integrity testing methods include: peel testing (measures force required to separate seal), burst testing (measures seal resistance to internal pressure), visual inspection (detects seal defects), and dye penetration (detects seal leaks) [1] . Pouch seal integrity testing is specifically critical for flexible pouch packaging, which is common for sterile medical devices. Package integrity testing labs perform seal integrity testing as part of ISO 11607 validation programs [1] .

Q: What is sterile packaging validation and ISO 11607 testing?

Sterile packaging validation (also called packaging validation testing or ISO 11607 testing ) is the process of demonstrating that packaging systems for terminally sterilized medical devices maintain sterility and device integrity [1] . ISO 11607 is the international standard that defines requirements for packaging systems [1] . ISO 11607-2 specifically covers validation requirements including package integrity testing , seal integrity testing , and performance testing [1] . Sterile packaging validation programs typically include: materials qualification, design validation, process validation, and performance testing. Package integrity testing labs perform ISO 11607 testing to ensure packaging meets regulatory requirements for FDA 510(k), CE marking, and other regulatory submissions [2] .

Q: What is packaging validation and why do I need it?

Packaging validation demonstrates that your packaging system maintains sterility and device integrity throughout distribution and storage [1] [2] . Validation typically includes package integrity testing , seal integrity testing , and distribution simulation [1] . Validation is required for sterile devices with packaging [1] [2] [3] . Regulatory authorities (FDA, EU MDR, etc.) require packaging validation testing to demonstrate that packaging maintains sterility and protects the device [2] [3] . The extent of validation depends on packaging type, device category, and regulatory pathway.

Q: What's the difference between real-time and accelerated aging?

Real-time aging studies the device under normal storage conditions over the claimed shelf-life period [1] . For a 2-year shelf-life, real-time aging takes 2 years. Real-time aging is typically less expensive per test but requires the full shelf-life duration. Accelerated aging uses elevated temperature/humidity to simulate longer time periods [1] . For a 2-year shelf-life, accelerated aging typically takes 3-6 months. Accelerated aging costs more per test but can be completed much faster. FDA accepts both methods [1] , but accelerated aging requires validation of the acceleration factor. Many laboratories offer both methods. Real-time aging is often preferred for complex devices or when acceleration factors are uncertain.

Q: Do I need distribution testing?

Distribution testing simulates distribution stresses including vibration, shock, drop, compression, and climate variations [1] [2] . Distribution testing is: Often required for devices that are shipped/distributed [1] [2] ; Valuable for demonstrating packaging can withstand distribution stresses; Required for some regulatory pathways; and Useful for identifying packaging weaknesses before market launch. ASTM D4169 [1] and ISTA [2] provide standard test methods for distribution simulation. Distribution testing adds cost ($3,000 - $10,000+) but is often required for regulatory submissions. Some laboratories offer distribution testing, while others focus on packaging/shelf-life only.

Q: Which packaging tests do I need?

The required packaging tests depend on packaging type, device category, and regulatory pathway. Common tests: Package integrity — visual inspection, dye penetration, bubble emission [1] ; Seal strength — measurement of seal strength [1] ; Burst strength — package resistance to internal pressure [1] ; Compression — package resistance to compression forces [1] ; Vibration — package resistance to vibration [1] ; Drop — package resistance to drop impacts [1] . ISO 11607 [1] provides requirements for packaging validation. A packaging validation plan helps determine which tests are needed. Many laboratories offer validation plan development services to help you determine which tests are required.

Q: How long does packaging + shelf-life testing take?

Testing timelines vary by test type, shelf-life duration, and laboratory capacity. Typical timelines: Packaging validation: 4-8 weeks; Real-time aging: Takes the full shelf-life duration (e.g., 2 years for a 2-year shelf-life); Accelerated aging: 3-6 months for a 2-year equivalent; Distribution simulation: 2-4 weeks. Total project time: Packaging validation only: 4-8 weeks; With real-time aging: Full shelf-life duration (e.g., 2 years); With accelerated aging: 3-6 months; With distribution: Add 2-4 weeks. Factors affecting timeline include: Shelf-life method (real-time takes the full duration, accelerated is faster), shelf-life duration (longer claims = longer studies), laboratory backlog, sample preparation time, and retest needs (if initial tests reveal issues). Rush services (packaging validation within 2-4 weeks) are available at most laboratories but typically cost 20-50% more. Plan for 4-8 weeks for packaging validation, plus shelf-life duration for aging studies.

Q: What samples do I need to provide?

Sample requirements vary by test type, shelf-life duration, and device type. Typical requirements: Packaging validation: Finished packaged devices (often 20-50 samples, depending on test design); Real-time aging: Finished packaged devices (often 30-100+ samples, depending on shelf-life duration and test intervals); Accelerated aging: Finished packaged devices (often 20-50 samples, depending on test design); Distribution simulation: Finished packaged devices (often 10-30 samples, depending on test design). Some tests can use packaging samples, while others require finished devices. Laboratories typically provide detailed sample requirements in their quotes. Samples are usually not returned (disposed after testing) unless specifically requested. More complex devices or packaging may require additional samples.

Q: Can I use prior packaging/shelf-life data?

Prior packaging/shelf-life data can be used if: The data is from the same or equivalent packaging system [1] ; The data was generated using appropriate test methods (ISO 11607, etc.) [1] ; The data is recent and still valid (typically within 5-10 years, depending on packaging stability); and The data covers the required tests for your device's packaging type and regulatory pathway. Packaging equivalency can also reduce testing — if your packaging is equivalent to previously tested packaging, you may be able to use prior data. Many laboratories offer prior data evaluation services ($2,000 - $5,000) to assess whether your existing data is adequate or if additional testing is needed. Using prior data can significantly reduce cost and timeline.

Compare accredited package integrity testing labs and seal integrity testing providers. Get quotes for package integrity testing, packaging integrity testing, seal integrity testing, pouch seal integrity testing, and sterile packaging validation. Find ISO 11607-2 testing labs and packaging validation testing providers.

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Compare Packaging + Shelf-life + Distribution Testing Providers

For the most complete service details (including category-specific capabilities and requirements), open any provider profile below. Each profile contains full coverage, service details, and a direct quote request flow.

Eurofins Medical Device Testing

Eurofins Medical Device Testing offers comprehensive testing and certification services for medical devices. They ensure product safety, efficacy, and compliance with global regulatory standards.

Eurofins Medical Device Testing is a global leader providing extensive testing, inspection, and certification services for the medical device industry. With a vast network of over 950 laboratories across 60 countries and more than 65,000 employees, they offer expertise in biocompatibility testing, chemical, physical, mechanical, clinical, environmental, and electrical safety testing. Their services are designed to help manufacturers navigate complex regulatory landscapes, including REACH and other global standards, ensuring products meet stringent quality and safety requirements before market entry. Eurofins supports the entire product lifecycle, from raw materials to finished goods, providing technical compliance files and facilitating access to global markets. They are committed to ensuring human health and environmental safety through rigorous testing and consulting, making them a trusted partner for medical device companies worldwide seeking to achieve compliance and market success.

Website: eurofins.com

HQ: US

Languages: English

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Smithers

Smithers is a leading provider of testing, consulting, and information services for medical devices, pharmaceuticals, and consumer products. They offer comprehensive packaging testing, shelf life studies, and material science services.

Smithers is a global provider of testing, consulting, and information services serving medical devices, pharmaceuticals, consumer products, and other industries. With laboratories and offices worldwide, Smithers offers comprehensive packaging testing services including ISO 11607 testing, shelf life studies, accelerated aging, distribution simulation, and packaging validation. Their expertise spans material science, regulatory compliance, and product development support. Smithers helps manufacturers ensure their packaging meets regulatory requirements and maintains product integrity throughout distribution and storage.

Website: smithers.com

HQ: Smithers, CA

Languages: English

Packaging Tests: Package integrity, Seal strength, Burst strength

Shelf-Life Methods: Accelerated aging

Standards: ISTA, ISO 11607

Accredited: No

Climate Chambers: Yes

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Westpak

Westpak is a trusted test laboratory specializing in packaging, shelf-life, and accelerated aging testing. They offer comprehensive solutions for various industries, ensuring product reliability and compliance.

Westpak is a leading test laboratory dedicated to providing expert testing services across a wide range of industries. They specialize in packaging testing, shelf-life testing, accelerated aging, material analysis, and cold chain testing, among others. Their commitment to excellence ensures that clients receive reliable and high-quality results. With a focus on product reliability and sustainability, Westpak offers customized testing solutions built to meet any industry need. They are experts in ASTM & ISTA test standards, providing critical data for product development and market readiness. Their services are essential for medical devices and can be adapted for numerous other sectors requiring rigorous testing. Westpak provides valuable resources such as webinars, white papers, and an accelerated aging time calculator to support their clients. They are committed to customer service, aiming to rival their passion for testing. For inquiries or to request a quote, Westpak can be reached via their toll-free number.

Website: westpak.com

HQ: US

Countries: United States, Poland

Languages: English

Packaging Tests: Package integrity, Other

Shelf-Life Methods: Accelerated aging, Both

Standards: ISTA, Other

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DDL, Inc.

DDL provides expert packaging, product, and materials testing services, specializing in shelf-life studies and validation for medical devices, pharmaceuticals, and consumer goods. With over 35 years of experience, they ensure reliable quality and regulatory compliance.

DDL, Inc. is an independent testing laboratory with over 35 years of experience providing specialized testing expertise to the medical device, pharmaceutical, and consumer goods industries. They offer a comprehensive suite of services including packaging validation, shelf-life studies (accelerated and real-time aging per ASTM F1980), and materials testing. DDL is committed to delivering fast, accurate, and high-quality results, ensuring confidence in product performance and safety while achieving regulatory compliance. Their services are crucial for establishing shelf life and expiration dates, utilizing methodologies like accelerated aging based on thermodynamic principles and real-time aging for verification. DDL's ISO 17025 Accredited & GMP Laboratory status underscores their commitment to quality and reliability. They serve as a seamless extension to their clients' organizations, offering knowledgeable and responsive support for all testing needs. With multiple lab locations in Minnesota, California, and New Jersey, DDL is well-positioned to support a wide range of clients. They offer specialized testing for medical devices, including injection system testing, infusion set testing, surgical suture testing, guidewire testing, product vibration testing, and shock and fragility testing, among others. Their expertise also extends to materials testing such as coefficient of friction, flexural bend, film, fatigue, and shear testing.

Website: ddlinc.com

HQ: Eden Prairie, US

Languages: English

Packaging Tests: Package integrity, Seal strength, Burst strength

Shelf-Life Methods: Accelerated aging

Standards: ISO 11607, ASTM D4169, ISTA

Accredited: Yes

Climate Chambers: Yes

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Life Science Outsourcing, Inc.

Life Science Outsourcing (LSO) is an FDA-registered and ISO 13485-certified medical device contract manufacturer offering end-to-end solutions including assembly, packaging, sterilization, and testing.

Life Science Outsourcing (LSO) is a full-service, FDA-registered and ISO 13485-certified medical device contract manufacturer specializing in accelerating product launch and reducing costs. They provide comprehensive, end-to-end solutions under one roof, integrating assembly, kitting, packaging, and quick-turn sterilization. LSO offers services such as cleanroom device assembly, custom medical kits with traceability, and various sterilization modalities including EtO, steam, gamma, and ebeam, all with full validation to ISO 11135 and ISO 11137 standards. Their packaging testing team performs ISO 11607 validations, accelerated aging, seal integrity, and distribution simulation to ensure market readiness and regulatory compliance. As a single-source partner, LSO streamlines late-stage builds, reduces risk, lead time, and handoffs. They also provide cleaning and decontamination solutions for reusable devices and offer quality incubator services to support startups and medical device innovators in meeting investor expectations and achieving accelerated growth.

Website: lso-inc.com

HQ: US

Languages: English

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Infinity Laboratories

Infinity Laboratories offers comprehensive analytical testing services for pharmaceutical and medical device industries, specializing in biocompatibility testing, sterility assurance, and material characterization.

Infinity Laboratories is a leading analytical testing partner for raw materials, in-process materials, finished products, and packaging. They offer a wide range of services including materials characterization, facility and process validation, sterilization, and sterility assurance. Their expertise covers package testing, environmental monitoring, EO residuals, gas & water testing, chemistry testing, wet chemistry testing, microbiology testing, stability testing, and laboratory & process instrumentation services. With a network of nationwide labs, Infinity Laboratories provides high-quality, reliable data under demanding timelines, ensuring strict compliance with GMP and other regulatory standards. They support analytical method development and validation for a diverse range of techniques and products, guided by the standards of the world’s leading regulatory agencies. Their services are crucial for ensuring product quality and patient safety throughout the entire product lifecycle. Specializing in biocompatibility testing, Infinity Laboratories offers comprehensive wet chemistry testing, stability testing, water testing, and microbiology testing. They adhere to standards set by organizations like USP-NF, EP, and JP, providing critical insights into product integrity and safety for pharmaceutical and medical device clients.

Website: infinitylaboratories.com

HQ: US

Languages: English

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Eurofins Medical Device Testing

Eurofins Medical Device Testing offers comprehensive testing and consulting services for REACH and similar regulations, ensuring product safety and compliance for global market access.

Eurofins Medical Device Testing is a global service provider specializing in testing and consulting for chemical regulations like REACH. They offer a comprehensive range of services to ensure compliance with regulatory requirements throughout the product lifecycle, from raw materials to finished goods. With a vast network of laboratories and over 65,000 employees across 60 countries, Eurofins provides multi-disciplined research capabilities, market-leading product expertise, and technical support. Their services extend to quality assurance, control, and regulatory programs for a wide array of consumer products, helping businesses access global markets. Eurofins' expertise covers chemical, physical, mechanical, clinical, environmental, and electrical safety testing, among others. They also provide product inspections and audits to international schemes or custom-made requirements, ensuring products meet efficacy and suitability standards for consumers.

Website: eurofins.com

HQ: US

Countries: United States, Brazil

Languages: English

Packaging Tests: Package integrity, Seal strength, Burst strength

Shelf-Life Methods: Real-time aging, Accelerated aging, Both

Standards: ISO 11607, ISO 16775, Other

Climate Chambers: Yes

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UL Solutions

UL Solutions is a global safety science leader providing testing, certification, and advisory services to enhance safety, sustainability, and regulatory compliance for businesses worldwide.

UL Solutions is a premier global safety science leader dedicated to helping companies navigate complex challenges. They offer a comprehensive suite of services including testing, certification, auditing, and advisory, all aimed at demonstrating safety, enhancing sustainability, strengthening security, delivering quality, managing risk, and achieving regulatory compliance. With a focus on innovation and safety science, UL Solutions empowers businesses to bring products and services to market with confidence. Their expertise spans various industries, assisting clients in accelerating product development, accessing new markets, and ensuring adherence to global standards. They provide critical support for hazardous locations compliance, facility certifications, and personnel qualifications, fostering trust and reliability in the global marketplace. Leveraging extensive digital tools and a worldwide network of experts, UL Solutions helps clients manage regulatory, supply chain, and sustainability challenges effectively. Their commitment is to foster a safer, more secure, and sustainable world by enabling companies to innovate with confidence and meet the evolving demands of the global economy.

Website: ul.com

HQ: US

Languages: English

Packaging Tests: Package integrity, Seal strength, Burst strength

Shelf-Life Methods: Real-time aging, Accelerated aging, Both

Standards: Other

Climate Chambers: Yes

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Intertek

Intertek offers specialized packaging and shelf-life testing services. They provide expert analysis to ensure product integrity and compliance.

Intertek is a global leader in testing, inspection, and certification services. For the packaging and shelf-life testing directory, they offer comprehensive solutions to help businesses validate product quality and extend market reach. Their services are designed to meet stringent industry standards and regulatory requirements, ensuring that products are safe, reliable, and meet consumer expectations. Leveraging advanced methodologies and state-of-the-art facilities, Intertek's experts conduct rigorous testing to assess the impact of various environmental factors on packaging and product shelf life. This includes evaluating material performance, barrier properties, and the effects of temperature, humidity, and light. By partnering with Intertek, companies can gain critical insights into their product's longevity, optimize packaging designs, and reduce the risk of product spoilage or degradation. Their commitment to accuracy and efficiency ensures timely results, enabling clients to make informed decisions and bring their products to market with confidence.

Website: intertek.com

HQ: United States

Languages: English

Pricing model: Custom pricing

Rush Available: Yes

Packaging Tests: Package integrity, Seal strength, Burst strength

Shelf-Life Methods: Real-time aging, Accelerated aging, Both

Standards: ISO 11607, ASTM D4169, ISTA

Accredited: Yes

Climate Chambers: Yes

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SGS

SGS&CO offers comprehensive packaging shelf-life testing solutions, leveraging AI, data management, and analytics to meet modern brand needs in the creative production ecosystem.

SGS&CO provides specialized packaging shelf-life testing services, essential for ensuring product integrity and market readiness. Their expertise spans across brand consulting, AI solutions, automation, analytics, and insights, all powered by advanced technology. They focus on harnessing the power of artificial intelligence, data management, automation, and analysis, tailored to the specific requirements of modern brands within the creative production ecosystem. SGS&CO is committed to building new futures at scale for their partners, offering a robust suite of services designed to optimize brand performance and product longevity.

Website: sgsco.com

HQ: East Syracuse, GB

Countries: United States, Canada

Languages: English

Rush Available: Yes

Packaging Tests: Other

Shelf-Life Methods: Accelerated aging

Standards: Other

Accredited: Yes

Climate Chambers: Yes

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Element Materials Technology

Element U.S. Space & Defense offers accredited testing and engineering services for mission-critical programs in defense, aerospace, and commercial sectors. They specialize in environmental simulations, EMC/EMI, ballistics, and dynamics testing.

Element U.S. Space & Defense, formerly NTS Technical Systems, is a trusted partner for mission-critical testing and engineering services, serving leading organizations and government agencies since 1961. With a focus on defense, aerospace, and commercial compliance, they provide advanced test services including environmental simulations, EMI/EMC testing, dynamics, hydraulics, and ballistics. Their state-of-the-art facilities, including locations in Belcamp, MD, and Camden, AR, are equipped to handle a wide range of testing needs. This includes simulating various climatic conditions, performing advanced vibration and acoustics testing, and conducting ballistics testing with various ammunition types. They are also an ITAR-registered ordnance test and evaluation facility. Element U.S. Space & Defense holds numerous accreditations, including ISO/IEC 17025, and is recognized by organizations like the U.S. Department of Justice and the Defense Logistics Agency. Their expertise covers mechanical testing, thermal testing, acoustics, vibration, and specialized areas like body armor testing and NEBS compliance, ensuring products are ready for real-world use and meet rigorous regulatory requirements.

Website: elementdefense.com

HQ: Belcamp, US

Countries: United States, United Kingdom, Europe, Asia

Languages: English

Pricing model: Custom pricing

Packaging Tests: Vibration, Drop, Compression

Shelf-Life Methods: Accelerated aging

Standards: ISTA, Other

Accredited: Yes

Climate Chambers: Yes

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NAMSA

NAMSA is a leading medical device Contract Research Organization (CRO) offering comprehensive testing, preclinical research, clinical trials, and regulatory consulting services. They support clients from concept to commercialization, ensuring device safety, efficacy, and compliance worldwide.

NAMSA is a premier Contract Research Organization (CRO) dedicated to advancing medical device innovation and safety globally. With over 50 years of experience, NAMSA provides unparalleled expertise in medical device testing, preclinical research, clinical trials, and regulatory consulting. Their services encompass a wide range, including US FDA and EU MDR/IVDR consulting, biological safety assessments, and market research. NAMSA's team of over 1,400 professionals operates in state-of-the-art GLP-compliant and AAALAC-accredited facilities across North America, Europe, and Asia. They have supported over 3,000 medical device and IVD companies annually, from startups to multinationals, helping them navigate complex regulatory landscapes and shorten time-to-market. NAMSA's commitment to client success is evident in their deep industry knowledge and client-centric approach. They offer strategic guidance for regulatory submissions, QMS compliance, and post-market support, ensuring devices meet the highest standards of patient and user safety. Whether it's conducting over 100,000 medical device tests annually or providing expert consultation on complex submissions, NAMSA is the trusted partner for medical device and IVD manufacturers worldwide.

Website: namsa.com

HQ: North Canton, US

Countries: United States, United Kingdom, Switzerland, Canada, Japan, Australia, Brazil, Europe, Asia

Languages: English

Pricing model: Custom pricing

Packaging Tests: Package integrity, Seal strength, Burst strength

Shelf-Life Methods: Real-time aging, Accelerated aging, Both

Standards: ISO 11607, ASTM D4169, ISTA

Accredited: Yes

Climate Chambers: Yes

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Nelson Labs

Nelson Labs is a leading global provider of laboratory testing and expert advisory services for MedTech and pharmaceutical companies. They offer comprehensive microbiological and analytical testing to ensure product safety and compliance.

Nelson Labs is a premier global provider of laboratory testing and expert advisory services, specializing in supporting MedTech and pharmaceutical companies. With a strong commitment to safeguarding global health, they offer comprehensive microbiological and analytical testing solutions. Their services are crucial for ensuring product safety, regulatory compliance, and successful market entry. The company emphasizes building strong customer partnerships, driven by a shared goal of improving and saving lives. Nelson Labs' expertise is recognized globally, with a track record of quality and reliability that sets them apart. They provide personalized service through a worldwide network of labs and facilities, ensuring timely turnaround and superb quality. A significant 99.4% of their sales orders come from repeat customers, highlighting their dedication to client satisfaction and long-standing partnerships. Nelson Labs' experts actively contribute to industry standards and can guide clients through the entire product development lifecycle. They offer a wide array of over 800 microbiological and analytical laboratory tests, including specialized services like accelerated aging package testing. Their Salt Lake City, Utah headquarters is an FDA-registered and ISO 17025 accredited facility, underscoring their commitment to the highest standards.

Website: nelsonlabs.com

HQ: Salt Lake City, US

Countries: United States, Mexico, Europe, Asia

Languages: English

Packaging Tests: Package integrity, Seal strength

Shelf-Life Methods: Accelerated aging, Real-time aging, Both

Standards: FDA Guidance

Accredited: Yes

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Packaging Compliance Labs

Packaging Compliance Labs offers expert package testing, contract packaging, and engineering services for medical devices. They ensure compliance with ISO 11607 and accelerate your path to market.

Packaging Compliance Labs is your dedicated partner for comprehensive medical device packaging solutions. Specializing in package testing, contract packaging, and engineering services, they help ensure your products meet critical validation and compliance standards, including ISO 11607. Their state-of-the-art, ISO 17025-accredited facility provides a full suite of testing services, including transit testing, shelf-life testing (both real-time and accelerated aging per ASTM F1980), sterile barrier integrity, and material & label testing. They leverage advanced techniques, such as accelerated aging, to simulate long-term effects and support shelf-life claims, significantly reducing time to market. For manufacturers facing small batch challenges, their ISO Class 7 cleanroom offers customized contract packaging solutions. This includes pre-validated packaging platforms, labeling, precision cleaning, sterilization validation, and sterile product management. With in-house packaging engineers, Packaging Compliance Labs provides end-to-end support, from concept to validation, streamlining the product lifecycle and mitigating risks. They are committed to helping medical device manufacturers navigate complex regulatory landscapes and achieve speed to market with confidence, ensuring devices are safe for patient use.

Website: pkgcompliance.com

HQ: Boulder, US

Countries: United States

Languages: English

Pricing model: Custom pricing

Packaging Tests: Package integrity, Seal strength, Drop

Shelf-Life Methods: Real-time aging, Accelerated aging, Both

Standards: ISO 11607, FDA Guidance, Other

Accredited: Yes

Climate Chambers: Yes

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Ten-E Packaging Services

Ten-E Packaging Services offers specialized packaging solutions and testing services, focusing on shelf-life extension and product integrity for various industries.

Ten-E Packaging Services is a dedicated provider of advanced packaging solutions with a strong emphasis on enhancing product shelf life and ensuring integrity. They cater to a diverse range of industries, offering expertise in material science, packaging design, and rigorous testing protocols. Their services are crucial for businesses looking to optimize product longevity, reduce waste, and maintain quality from production to consumer. As a specialist in packaging and shelf-life testing, Ten-E Packaging Services helps clients navigate complex regulatory requirements and market demands. They leverage innovative technologies and deep industry knowledge to develop customized packaging strategies that meet specific product needs and environmental considerations. Their commitment extends to providing reliable and cost-effective solutions that contribute to the overall success and sustainability of their clients' products.

Website: ten-e.com

HQ: Newport, US

Countries: United States

Languages: English

Packaging Tests: Drop, Seal strength, Burst strength

Shelf-Life Methods: Accelerated aging

Standards: ISTA, ASTM D4169, Other

Accredited: Yes

Climate Chambers: Yes

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Micom Laboratories

Micom Laboratories offers ISO/IEC 17025 accredited material and packaging testing services. They provide accelerated aging, environmental simulation, and mechanical testing to support product development and compliance.

Micom Laboratories is an ISO/IEC 17025 accredited material testing laboratory with over 25 years of experience. They specialize in providing reliable and standard-compliant testing services for a wide range of industries, including automotive, aerospace, furniture, medical devices, and packaging. Their core services include accelerated aging, packaging testing, and material testing. They are ISTA accredited and part of Amazon.com's package laboratory supplier network (APASS), enabling them to test to various North American packaging standards. Micom helps clients understand how shipped goods will react to different shipping conditions and atmospheric challenges. Micom also offers a comprehensive suite of material testing services, covering mechanical properties, physico-chemical properties, and environmental simulation. They are equipped to test prototypes, simulate intensive product use, validate designs, and investigate field failures. Their quality control system complies with ISO 17025, ensuring accurate and dependable results for their diverse customer base.

Website: micomlab.com

HQ: Canada

Languages: English

Packaging Tests: Package integrity, Seal strength, Burst strength

Shelf-Life Methods: Accelerated aging, Both

Standards: ASTM D4169, ISTA

Accredited: Yes

Climate Chambers: Yes

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Keystone Compliance

Keystone Compliance offers specialized testing services for the packaging and shelf-life industry. They ensure product integrity and compliance with industry standards.

Keystone Compliance is a dedicated provider of specialized testing services, focusing on the critical areas of packaging and shelf-life analysis. They are committed to helping businesses ensure the integrity, safety, and longevity of their products through rigorous testing protocols. Their expertise supports clients in meeting stringent industry regulations and consumer expectations for product quality. By partnering with Keystone Compliance, companies can gain confidence in their product's performance and market readiness, minimizing risks associated with product degradation or non-compliance. They are a valuable resource for businesses seeking to validate their packaging solutions and shelf-life claims.

Website: keystonecompliance.com

HQ: United States

Countries: United States, Canada, Europe

Languages: English

Packaging Tests: Package integrity, Seal strength, Burst strength

Shelf-Life Methods: Real-time aging, Accelerated aging

Standards: ASTM D4169, ISTA

Accredited: Yes

Climate Chambers: Yes

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Applus+ Laboratories

We provide chemical and thermal analysis services around the world. Our expertise includes routine and high-end testing of products, materials and additives to trace levels.

Website: appluslaboratories.com

HQ: United States

Languages: English

Packaging Tests: Package integrity, Seal strength, Burst strength

Shelf-Life Methods: Real-time aging, Accelerated aging, Both

Standards: ISO 11607, ASTM D4169, ISTA

Accredited: Yes

Climate Chambers: Yes

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Life Science Outsourcing, Inc.

LSO provides comprehensive medical device packaging and testing services, including ISO 11607 validation, accelerated aging, and distribution simulation to ensure product safety and market readiness.

Life Science Outsourcing (LSO) is an FDA-registered and ISO 13485-certified provider specializing in medical device packaging and testing. They offer end-to-end solutions designed to accelerate time-to-market and reduce costs for OEMs and startups. Key services include ISO 11607 packaging validation (Parts 1 & 2), accelerated aging studies (ASTM F1980), and distribution simulation testing (ISTA, ASTM D4169). LSO ensures sterile barrier systems are designed, sealed, tested, and proven to protect devices through their shelf life and open aseptically at the point of use. Their expertise extends to cleanroom assembly, kitting, sterilization (EtO, steam, gamma, ebeam), and supply chain management. LSO acts as a single-source partner, streamlining processes from initial planning to final reporting, ensuring compliance with global standards and audit-readiness.

Website: lso-inc.com

HQ: Brea, US

Countries: United States, Asia

Languages: English

Pricing model: Custom pricing

Rush Available: Yes

Packaging Tests: Seal strength, Burst strength, Package integrity

Shelf-Life Methods: Real-time aging, Accelerated aging, Both

Standards: ISO 11607, ISO 13485, FDA Guidance

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Infinity Laboratories

Infinity Laboratories offers comprehensive analytical testing services for pharmaceutical, medical device, and packaging industries. Specializing in chemistry, microbiology, stability, and package testing to ensure product quality and patient safety.

Infinity Laboratories is your analytical testing partner for raw materials, finished products, and packaging, serving the pharmaceutical and medical device sectors. They provide expertise in materials characterization, facility and process validation, sterilization, and sterility assurance to help bring products to market safely and effectively. Their extensive testing capabilities include Analytical Chemistry & Physical Testing, Wet Chemistry Testing, Stability Testing, Water Testing, Microbiology Testing, Sterility Assurance Testing, Container Testing, Extractables and Leachables Testing, 510(k) Testing, PMA Testing, and Package Testing. Infinity Laboratories operates a network of nationwide labs, offering the flexibility of local service with the resources of a national organization, all while adhering to GMP and other regulatory standards. They specialize in method development and validation, ensuring rigorous testing for product quality and patient safety. Whether it's compendial testing according to USP, EP, and JP standards, or specialized studies like forced degradation and photostability, Infinity Laboratories provides timely and dependable results with high data integrity.

Website: infinitylaboratories.com

HQ: USA

Countries: United States, Netherlands, Asia

Languages: English

Packaging Tests: Package integrity, Other

Shelf-Life Methods: Real-time aging, Accelerated aging, Both

Standards: FDA Guidance, Other

Climate Chambers: Yes

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Pacific BioLabs

Pacific BioLabs is a leading CRO offering comprehensive life science testing services, including packaging and shelf-life testing. Established in 1972, they specialize in cGMP and GLP compliant testing for pharmaceuticals, biologics, medical devices, and more.

Pacific BioLabs is a premier Contract Research Organization (CRO) with extensive experience in life science testing, serving industries such as packaging, shelf-life, pharmaceuticals, biologics, and medical devices. Established in 1972, the company is dedicated to providing high-quality, reliable testing services, emphasizing robust quality systems and regulatory compliance. Their services encompass a wide range, including small molecule and biologics manufacturing and development support, clinical trial bioanalysis, and medical device testing. Pacific BioLabs is committed to continuous improvement and operates with cGMP and GLP compliance in mind, ensuring adherence to stringent industry standards. They are FDA registered and ISO 17025 accredited, with animal science operations accredited by AAALAC. Located in the San Francisco Bay Area, Pacific BioLabs is equipped to handle diverse testing needs, from extractables and leachables to antimicrobial effectiveness and shelf-life studies. They aim to be a trusted partner for clients seeking expert scientific support and timely results, striving to become a paperless laboratory with optimal workflows.

Website: pacificbiolabs.com

HQ: Hercules, US

Countries: United States

Languages: English

Pricing model: Custom pricing

Packaging Tests: Other

Shelf-Life Methods: Accelerated aging, Both

Standards: ISO 13485, FDA Guidance, Other

Accredited: Yes

Climate Chambers: Yes

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Pace Life Sciences

Pace Life Sciences offers comprehensive packaging and distribution testing services for pharmaceuticals, medical devices, and consumer goods. Ensure product integrity and regulatory compliance from manufacture to end-user.

Pace Life Sciences specializes in providing critical packaging and distribution testing services tailored for the pharmaceutical, medical device, and consumer goods industries. They ensure that packaged products can withstand the rigors of manufacturing, storage, and transportation, safeguarding product integrity and efficacy. Leveraging expertise in simulated distribution testing, Pace Life Sciences utilizes standardized methods from ISTA and ASTM to evaluate package performance against hazards like drops, vibrations, and environmental changes. This is crucial for drug-device combination products, sterile medical device packaging (ISO 11607 compliance), and consumer goods subject to small parcel delivery. Their services extend to container closure integrity, labeling verification, and assessing the compatibility between drugs, devices, and packaging. By partnering with Pace Life Sciences, clients can gain confidence in their packaging systems, meet regulatory expectations, and ensure that lifesaving therapies and essential products reach the end-user in usable condition.

Website: pacelabs.com

HQ: US

Countries: United States

Languages: English

Packaging Tests: Package integrity, Seal strength, Vibration

Standards: ISO 11607, ISTA

Climate Chambers: Yes

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Oliver Healthcare Packaging

Oliver Healthcare Packaging offers specialized packaging solutions for the medical, diagnostic, and pharmaceutical industries. They provide sterile barrier packaging expertise and engineering support.

Oliver Healthcare Packaging is a global leader in providing advanced packaging solutions tailored for the healthcare sector, including medical devices, diagnostics, and pharmaceuticals. With decades of experience, their team of experts offers in-region support worldwide, assisting clients with defect analysis and engineering assessments to overcome packaging challenges. Their commitment extends to ensuring safe and effective product delivery to market faster, while also focusing on sustainability within the flexible packaging industry. Oliver Healthcare Packaging provides a comprehensive range of products such as DuPont™ Tyvek® pouches, barrier foil pouches, and various roll stock options, all designed to meet stringent industry standards. With headquarters in Trevose, PA, and additional global offices, Oliver Healthcare Packaging is strategically positioned to serve a diverse international clientele. They are dedicated to protecting patients and the environment through innovative and reliable packaging engineering.

Website: oliverhcp.com

HQ: Trevose, US

Countries: United States, United Kingdom, Germany, China, Singapore, Europe, Asia

Languages: English

Packaging Tests: Other

Shelf-Life Methods: Both

Standards: ISO 11607, ISO 13485, Other

Accredited: No

Climate Chambers: Yes

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J-Pac, LLC

J-Pac, LLC is a certified SBE\MBE\DBE and Hispanic owned energy company specializing in refined fuel supply and distribution across the US and Mexico. They offer comprehensive services including bulk fuel delivery, on-demand services, railcar and patio fuel services, frac tank storage, and transport

J-Pac, LLC is a certified SBE\MBE\DBE and Hispanic owned energy company dedicated to supplying refined fuel to government, military, and commercial clients across the US and Mexico. They pride themselves on providing high-quality products and exceptional service, fostering long-term business relationships. Their extensive service offerings include bulk fuel delivery via rail cars, trucks, and rack loading, as well as on-demand fuel delivery to meet any requirement. J-Pac, LLC also specializes in comprehensive railcar and patio fuel services, encompassing railcar storage, transloading (truck-to-truck and railcar-to-truck), movements, cleaning, and maintenance. They provide a diverse range of frac tank options, including closed-top, open-top, and double-wall tanks, tailored to meet specific storage needs for various industries. Furthermore, J-Pac, LLC offers expert fuel transportation services, ensuring safe and efficient delivery of petrol, diesel, jet fuel, and specialty fuels. Their advanced tracking systems provide real-time shipment updates, and their services are customized to meet unique client requirements, operating with a global reach and local expertise. They also provide specialized bobtail delivery services for the oil and gas sector, including fuel delivery to gas stations, commercial properties, industrial sites, and on-site refueling. J-Pac, LLC is committed to safety, efficiency, environmental responsibility, and compliance with all relevant regulations, making them a reliable partner in the energy supply chain.

Website: jpacglobal.com

HQ: USA

Languages: English

Pricing model: Per project

Lead Time: Start in 4-8 weeks

Quote SLA: 3-5 business days

Packaging Tests: Package integrity

Shelf-Life Methods: Accelerated aging

Standards: ISO 11607

Accredited: No

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Lansmont Corporation

Lansmont is a global leader in shock and vibration testing solutions, offering advanced technology and consulting to optimize product performance, packaging, and durability for diverse industries.

Lansmont Corporation provides cutting-edge shock and vibration testing solutions, empowering product and packaging engineers worldwide. Their Field-to-Lab® approach helps identify product weaknesses, optimize packaging, and achieve the ideal balance between product performance and durability in its intended environment. Lansmont's advanced technology and expert consulting services assist clients in reducing damage, enhancing quality, and promoting sustainability. They equip engineers with the tools to uncover potential product challenges during transport and use, ultimately driving business success through improved product quality and confidence in design limits. Lansmont's offerings include a range of testing machines such as compression testers, drop testers, and mechanical shakers, alongside comprehensive support and calibration services.

Website: lansmont.com

HQ: Monterey, USA

Languages: English

Rush Available: Yes

Packaging Tests: Package integrity, Seal strength, Burst strength

Shelf-Life Methods: Real-time aging, Accelerated aging, Both

Standards: ISO 11607, ASTM D4169, ISTA

Accredited: Yes

Climate Chambers: Yes

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Q Laboratories

Q Laboratories offers comprehensive analytical chemistry, microbiology, and stability testing services. Specializing in packaging shelf-life studies, they ensure product safety, compliance, and performance across various industries.

Since 1966, Q Laboratories has been a trusted partner for analytical chemistry, microbiology, and stability testing solutions. They provide end-to-end support for raw materials, intermediates, and finished goods, including QC and release testing, stability studies, and R&D. Their expertise spans diverse product types, water system validation, environmental monitoring, and FDA compliance. Specializing in packaging shelf-life and challenge studies, Q Laboratories helps establish "best if used by" and "use by" dates, validates preservative systems, and designs custom protocols. They accommodate multiple storage temperatures and can perform accelerated shelf-life studies. Microbiological challenge testing evaluates how products support or inhibit microbial growth, validating processes to reduce risks. Q Laboratories serves industries including Personal Care, Household Care, Prescription Drug, Food Safety, and Water Treatment. They are ISO/IEC 17025 Accredited by A2LA, AFNOR Certified, DEA Registered, EPA Certified for Drinking Water Testing, FDA and MoCRA Registered, and AOAC Certified. Located in Cincinnati, Ohio, Q Laboratories is committed to delivering scientifically rigorous, regulatory-compliant data to ensure your products meet the highest standards.

Website: qlaboratories.com

HQ: Cincinnati, US

Countries: Global

Languages: English

Quote SLA: 3-5 business days

Packaging Tests: Other

Shelf-Life Methods: Real-time aging, Accelerated aging, Both

Standards: Other

Accredited: Yes

Climate Chambers: Yes

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RJM & Associates

RJM & Associates offers specialized Community Reinforcement Approach (CRAFT) training for professionals. They provide intensive 2-day workshops and certification programs designed to equip clinicians and supervisors with effective family-focused SUD intervention skills.

RJM & Associates, led by Dr. Robert J. Meyers, specializes in providing comprehensive Community Reinforcement Approach (CRAFT) training. Their programs are designed for professionals seeking to enhance their skills in supporting families impacted by Substance Use Disorder (SUD). The core offerings include an intensive 2-day CRAFT training, aimed at making participants comfortable and confident with the CRAFT model for immediate client application. They also offer Clinician Certification and Supervisor Certification, enabling professionals to deliver high-fidelity CRAFT services and ensuring agency sustainability through train-the-trainer models. For those who interact with families affected by SUD but do not directly facilitate client sessions, RJM & Associates provides curated lessons to deepen understanding of the family's role in recovery. Training options include on-demand individual training and trainer-led group sessions, all featuring Dr. Meyers' expertise. The goal is to empower professionals with empirically supported strategies to improve client outcomes.

Website: rjm-associates.com

HQ: Toronto, Canada

Countries: China, Singapore, Asia

Languages: English

Pricing model: Custom pricing

Rush Available: Yes

Packaging Tests: Other

Shelf-Life Methods: Both

Standards: Other

Climate Chambers: Yes

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Medical Packaging Inc.

Medical Packaging Inc. (MPI) is a leading global manufacturer of unit dose medication and pharmaceutical packaging and labeling systems, equipment, and materials. They offer customized solutions for various market segments, including hospitals, specialty pharma, and pharmacies.

Medical Packaging Inc., LLC (MPI) is a premier manufacturer specializing in unit dose medication and pharmaceutical packaging and labeling systems, equipment, barcode labeling software, and MPI-certified consumable materials. Established in 1971, MPI provides top-quality products and custom-tailored solutions to customers worldwide, serving diverse market segments such as acute care hospitals, extended care facilities, specialty pharma, independent pharmacies, and pharmaceutical repackagers. MPI offers comprehensive medication packaging solutions, including machines and materials designed to meet unique customer needs and comply with regulatory requirements like CMS-mandated short-cycle dispensing models. Their offerings are available individually, in bundles, or as complete systems to ensure flexibility and efficiency for their clients. With a commitment to excellence, MPI develops and manufactures high-quality products at competitive prices, ensuring maximum reliability and ease of use. They provide outstanding customer service and technical support, fostering strong, ongoing relationships with customers, partners, and distributors. MPI's mission is to be a leader in pharmacy packaging solutions that contribute to patient safety while enhancing operational efficiency and profitability for their clients.

Website: medpak.com

HQ: Flemington, US

Languages: English

Pricing model: Custom pricing

Packaging Tests: Package integrity, Seal strength, Burst strength

Shelf-Life Methods: Real-time aging, Accelerated aging, Both

Standards: ISO 11607, ASTM D4169, ISTA

Accredited: No

Climate Chambers: Yes

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Doyen Medipharm

Packaging Gateway is a leading online resource for news, analysis, and procurement in the packaging industry. They offer insights into innovation, market trends, and company activities.

Packaging Gateway serves as a premier online platform dedicated to the packaging industry, providing essential reading for decision-makers. The site delivers the latest news, in-depth analysis, and procurement information, keeping professionals informed about key innovation areas, market trends, and the activities of leading companies. With a focus on themes driving the sector, such as reusability, recyclability, and lightweighting, Packaging Gateway offers instant lifecycle analytics and AI-based recommendations. Their content covers a wide range of sectors including Packaging Equipment, Converting Equipment, Specialised Packaging (Food, Beverage, Pharmaceutical), and various Packaging Materials. They also feature sections on Data Insights, Interviews, and Comment & Opinion. The platform aims to give businesses a competitive edge by providing leading industry insights through a visually engaging and interactive format. They are a valuable resource for understanding the dynamic landscape of the packaging world.

Website: doyenmedipharm.com

HQ: New York, USA

Languages: English

Packaging Tests: Package integrity, Seal strength, Burst strength

Shelf-Life Methods: Accelerated aging

Standards: ISO 11607, ASTM D4169, ISTA

Climate Chambers: Yes

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MedTech Testing Services

Credentia is a leading provider of nurse aide testing and credentialing services, offering support for NNAAP, MACE, and HHA exams. They empower individuals pursuing healthcare careers and assist facilities in growing their local health communities.

Credentia specializes in nurse aide testing and credentialing, playing a vital role in empowering the next generation of healthcare professionals. They offer comprehensive support for key certifications including the National Nurse Aide Assessment Program (NNAAP), Medication Aide Certification Exam (MACE), and Home Health Aide (HHA) exams. Whether you are embarking on a new career in healthcare or seeking to enhance your role within the community, Credentia provides the resources and guidance needed for success. They are dedicated to helping individuals achieve their certification goals and contribute to the growth of local healthcare systems. Credentia also facilitates state-specific contact information for various nursing boards and programs, ensuring that users can easily find the support and information they need. Their commitment extends to providing accessible customer service through multiple channels, including phone and email support, to assist with inquiries and exam registration.

Website: mpo-mag.com

HQ: Lake Mary, US

Languages: English

Pricing model: Custom pricing

Packaging Tests: Package integrity, Seal strength, Burst strength

Shelf-Life Methods: Real-time aging, Accelerated aging, Both

Standards: ISO 11607, ASTM D4169, ISTA

Accredited: No

Climate Chambers: Yes

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Steris Isomedix Services

STERIS Isomedix Services is a global leader in infection prevention products and services, specializing in sterilization solutions, sterile processing equipment, and surgical instrument care. They offer comprehensive support for healthcare facilities to ensure patient safety and operational efficien

STERIS Isomedix Services is a premier global provider dedicated to enhancing patient care through advanced infection prevention solutions. Their expertise spans a wide range of critical areas, including sterilization solutions, sterile processing equipment, and surgical instrument cleaning chemistries. They are committed to ensuring sterility assurance and monitoring, offering process improvement for sterile processing, and providing offsite reprocessing center services. With a focus on supporting healthcare facilities, STERIS offers specialized services such as endoscopy device management, endoscope reprocessing, and endoscopy equipment maintenance. They also provide essential surgical device repair and surgical instrument repair services, alongside their SecureCare Services, to maintain the integrity and functionality of vital medical equipment. Their commitment extends to providing comprehensive support, from routine maintenance and calibration to regulatory certifications and emergency repairs, ensuring optimal equipment performance and compliance. STERIS leverages its team of industry-recognized scientists and engineers to offer exceptional expertise in contamination control strategies, process optimization, regulatory compliance, validation support, and quality assurance. They help clients navigate complex regulatory landscapes, reduce operational risks, and accelerate time-to-market for critical healthcare products and services. This includes providing essential documentation like Certificates of Analysis and Safety Data Sheets, and offering technical learning resources.

Website: steris-ast.com

HQ: Mentor, US

Languages: English

Pricing model: Custom pricing

Packaging Tests: Package integrity, Seal strength, Burst strength

Shelf-Life Methods: Real-time aging, Accelerated aging

Standards: ISO 11607, ASTM D4169, ISTA

Accredited: No

Climate Chambers: Yes

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STERIS Isomedix Laboratory Services

STERIS AST offers contract sterilization and laboratory testing services, specializing in packaging and shelf-life testing for medical device and pharmaceutical manufacturers.

STERIS Applied Sterilization Technologies provides comprehensive contract sterilization, laboratory testing, and product and packaging testing services tailored for medical device and pharmaceutical manufacturers. They offer global contract sterilization and microbial reduction services utilizing a technology-neutral approach with radiation and gas technologies. Their laboratory testing and validation services encompass microbiological, analytical, and product and package testing. Specifically for packaging testing, STERIS AST simulates accelerated and real-time aging to determine product shelf life, evaluates performance under simulated environmental and distribution conditions, and assesses sterile barrier integrity and seal strength. They can assist manufacturers in extending the expiration dates of medical devices through rigorous testing and documentation. STERIS is a leading global provider focused on infection prevention and patient care support.

Website: steris-ast.com

HQ: US

Countries: United States, United Kingdom, Germany, Switzerland, China, Canada, France, Italy, Netherlands, Australia, Singapore, Asia

Languages: English

Packaging Tests: Package integrity, Seal strength

Shelf-Life Methods: Accelerated aging, Real-time aging, Both

Standards: ISO 11607, ASTM D4169, ISTA

Climate Chambers: Yes

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Trinity Sterile, Inc.

Trinity Sterile offers a wide range of high-quality medical products, including sterile surgical instruments, kits, and supplies. They focus on reducing costs and minimizing contamination risks with single-use options.

Trinity Sterile, Inc. is a dedicated supplier of high-quality medical products designed to meet the rigorous demands of healthcare professionals. Their extensive catalog features sterile single-use surgical instruments, phlebotomy tourniquets, premium underpads, and medical kits and trays. By offering single-use sterile instruments, Trinity Sterile helps reduce the costs associated with cleaning and sterilization while minimizing cross-contamination risks. The company also provides reusable options crafted for exceptional performance and versatility. Their commitment extends to wound care, with products like Esmark Sterile Bandages designed for uniform compression to aid in hemostasis and patient safety. Trinity Sterile emphasizes preparedness and robust supply chain solutions, ensuring healthcare facilities have reliable access to essential medical supplies. With a focus on customer satisfaction, Trinity Sterile provides responsive and knowledgeable support for product information, order assistance, and partnership opportunities. Their headquarters are located in Salisbury, Maryland, and they operate Monday to Friday, 8:00 AM – 5:00 PM EST.

Website: trinitysterile.com

HQ: Salisbury, US

Languages: English

Pricing model: Custom pricing

Packaging Tests: Package integrity, Seal strength, Burst strength

Shelf-Life Methods: Real-time aging, Accelerated aging

Standards: ISO 11607, ASTM D4169, ISTA

Climate Chambers: Yes

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QPS Evaluation Services

QPS Evaluation Services offers comprehensive product testing, certification, and advisory services for global market access. Specializing in electrical and electronic equipment, including those for explosive atmospheres, they ensure compliance with international standards.

QPS Evaluation Services, an Applus+ company, is a designated ATEX Notified Body and a recognized certification body for various international schemes like IECEE/CB and IECEx. They provide third-party testing, certification, and inspection services to help manufacturers get their products to market efficiently and compliantly. With extensive experience and accreditations from major bodies in Canada and the USA, QPS offers one-stop solutions for electrical and electronic products, including energy efficiency and safety compliance. They are also equipped to handle equipment intended for use in explosive atmospheres through the IECEx Scheme, facilitating international trade. Beyond testing and certification, QPS provides a Technical Advisory Service to guide clients through product development and regulatory requirements, ensuring successful certification from the outset. Their services are designed to be flexible and customer-focused, aiming to make the testing and certification process a satisfying experience. QPS operates service centers across Canada, including Toronto, Pointe Claire, and Moncton, offering on-site field evaluation and certification services for various equipment types, including medical, laboratory, and industrial automation equipment.

Website: qpsamerica.com

HQ: Toronto, CA

Languages: English

Pricing model: Custom pricing

Packaging Tests: Compression, Vibration, Drop

Shelf-Life Methods: Real-time aging, Accelerated aging, Both

Standards: ISO 11607, ASTM D4169, ISTA

Accredited: Yes

Climate Chambers: Yes

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Design Controls, LLC

Design Controls, LLC is a leader in custom-designed electrical switchgear, including distribution, energy management, and fuel control systems. They serve Retail, Commercial, C-Store, QSR, and Industrial sectors.

Custom Designed Controls, LLC, established in 2004, has become a recognized leader in the Integrated Power and Controls Industry. Initially focusing on the Supermarket Industry, the company has expanded its reach to serve C-store, QSR, Big Box Retail, and other Commercial markets. They specialize in custom-designed electrical switchgear, offering solutions such as electrical distribution, energy management controls, fuel control systems, and temporary power solutions. Their product line includes the trademarked EWALL® for integrated power and controls, the ECONTROL™ for EMS/BAS, and the EFUEL® product, which is particularly successful in C-store and Grocery Fuel Kiosk locations nationwide. CD Controls® was recognized as The Top Integrated Switchgear Manufacturer in 2025 by Electrical Business Review. They pride themselves on being a trusted partner, delivering high-quality equipment with professionalism, reliability, and a solutions-focused approach to meet the evolving demands of their diverse clientele.

Website: cdcontrols.com

HQ: Lavonia, US

Languages: English

Pricing model: Custom pricing

Packaging Tests: Other

Shelf-Life Methods: Both

Standards: Other

Accredited: No

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DuPont Tyvek Technical Support

Weatherization Partners, Ltd. provides building envelope solutions and technical support for residential, multifamily, and commercial construction. They offer product training, installation demonstrations, and risk management services.

Weatherization Partners, Ltd. (WPL) is a premier distributor specializing in building envelope systems, including DuPont Tyvek weather barriers, flashing systems, and more. They are dedicated to providing proven products and superior service to builders, installers, architects, developers, and contractors. WPL offers a comprehensive suite of services designed to support the construction industry. This includes risk management through their partnership with Risk Management Solutions (RMS) to identify and mitigate potential issues before construction begins. They also provide extensive training programs, including product installation, product knowledge, and CEU-accredited continuing education courses for AIA and GBCI. Jobsite support and specialist locators are also available to ensure proper installation and project success. Their team of specialists works directly with partners to offer product training, installation demonstrations, and demand-building support. WPL aims to be an integral part of their customers' teams, fostering long-lasting relationships and contributing to the construction of durable, energy-efficient, and high-performing buildings.

Website: dupont.com

HQ: US

Languages: English

Pricing model: Custom pricing

Packaging Tests: Other

Shelf-Life Methods: Both

Standards: ASTM D4169, Other

Accredited: No

Climate Chambers: Yes

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Fraunhofer IVV

Fraunhofer IVV is a leading research institute in applied research for secure food supply and sustainable packaging systems. They focus on developing bio-based and circular products and resource-efficient processes.

Fraunhofer IVV bundles competencies across five business fields: Food, Packaging, Product Effect, Processing Machines, and Recycling and Environment, to develop interdisciplinary optimal results. As a leading institute in applied research, they are dedicated to ensuring a secure supply of high-quality food and developing sustainable packaging systems. Their work aims for climate neutrality and shapes the technologies of tomorrow, developing bio-based and circular products, as well as resource-efficient processes for a livable and healthy future. They act as a catalyst for transformation towards a resilient and sustainable food and packaging economy, combining scientific findings with entrepreneurial requirements and social responsibility. Their developments are aligned with human needs and environmental protection, applying multidisciplinary expertise to various industry applications. Fraunhofer IVV is committed to fair and appreciative interaction, with open and transparent decision-making processes. They view change as an opportunity, continuously evolving through openness, self-reflection, and feedback. They foster employee potential, encourage participation, and promote team spirit to find creative solutions together. They are an integral partner for companies and research institutions, prioritizing good scientific practice, high-quality results, and customer satisfaction.

Website: ivv.fraunhofer.de

HQ: DE

Countries: United States, United Kingdom, Germany

Languages: English

Packaging Tests: Other

Shelf-Life Methods: Accelerated aging

Standards: Other

Accredited: No

Climate Chambers: Yes

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Kiwa

Kiwa offers comprehensive testing, inspection, and certification services to ensure product quality, safety, and compliance across various industries. They help businesses build trust and meet regulatory requirements.

Kiwa is a global leader in providing comprehensive testing, inspection, and certification (TIC) services. They help businesses ensure their products, services, personnel, and processes meet stringent quality, safety, and regulatory standards. With a presence in over 35 countries and a vast network of over 100 laboratories, Kiwa offers localized expertise and global reach. Their services are crucial for building customer confidence and navigating complex international regulations. Kiwa's offerings include digital solutions, training programs, and specialized inspections for sectors like energy, construction, and food safety. They are committed to fostering sustainable solutions and supporting business progress through rigorous evaluation and knowledge enhancement. Kiwa's expertise spans a wide array of areas, including hydrogen systems compliance, gas appliance safety, integrated management systems, sustainable construction, and OEM equipment compliance. They leverage advanced technologies and deep industry knowledge to deliver reliable results, helping clients minimize risks, optimize operations, and achieve their market goals.

Website: kiwalife.com

HQ: NL

Countries: United States

Languages: English

Pricing model: Custom pricing

Packaging Tests: Package integrity, Seal strength, Compression

Shelf-Life Methods: Real-time aging, Accelerated aging, Both

Standards: ISO 11607, ISO 16775, Other

Accredited: Yes

Climate Chambers: Yes

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TÜV SÜD

TÜV SÜD offers expert packaging and shelf-life testing services, ensuring product quality and compliance for your business.

TÜV SÜD is a leading global provider of testing, inspection, and certification services. Specializing in packaging and shelf-life testing, they help businesses ensure their products meet rigorous quality standards and regulatory requirements. Their expertise supports manufacturers in bringing safe, reliable, and compliant products to market, minimizing risks and enhancing consumer trust. With a commitment to excellence, TÜV SÜD's comprehensive testing solutions are designed to validate product integrity throughout its lifecycle.

Website: tuvsud.com

HQ: Germany

Languages: English

Packaging Tests: Package integrity, Seal strength, Burst strength

Shelf-Life Methods: Real-time aging, Accelerated aging

Standards: ISO 11607, ASTM D4169, ISTA

Accredited: Yes

Climate Chambers: Yes

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TÜV Rheinland

TÜV Rheinland offers comprehensive testing, inspection, certification, and training services for the packaging and shelf-life testing industry. They ensure product quality and compliance with global standards.

TÜV Rheinland is a leading global provider of technical services, offering expertise in testing, inspection, certification, and training. For the packaging and shelf-life testing directory, they provide critical services to ensure product quality, safety, and compliance with international regulations and standards. Their offerings include rigorous testing methodologies, comprehensive auditing processes, and expert consulting to help businesses navigate complex market requirements and achieve global trade confidence. With a strong focus on innovation and sustainability, TÜV Rheinland helps clients stay ahead of industry trends and regulatory changes. They provide detailed information on test marks, product certifications, and company accreditations through platforms like Certipedia. Their commitment extends to supporting businesses in achieving management system certifications, ensuring operational excellence and market readiness. Partnering with TÜV Rheinland means gaining access to a world of technical expertise dedicated to enhancing product integrity and market access.

Website: tuv.com

HQ: Köln, DE

Languages: English

Packaging Tests: Package integrity, Seal strength, Burst strength

Shelf-Life Methods: Real-time aging, Accelerated aging, Both

Standards: ISO 11607, ISO 16775

Climate Chambers: Yes

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Eurofins Packaging Testing Services

Eurofins Packaging Testing Services offers comprehensive testing and consulting for packaging shelf-life, ensuring product quality and regulatory compliance. They support businesses in meeting global market standards.

Eurofins Packaging Testing Services is a leading provider of specialized testing solutions for the packaging industry, focusing on shelf-life analysis. As part of the global Eurofins Scientific network, they leverage extensive expertise and a vast network of laboratories across 60 countries to support businesses worldwide. Their services are designed to help companies ensure their products meet stringent quality and regulatory requirements. This includes comprehensive testing and consulting for REACH and similar regulations, crucial for market access in Europe and beyond. They offer a wide range of services covering chemical, physical, mechanical, and environmental testing, as well as quality assurance and control throughout the supply chain. With a commitment to scientific excellence and customer support, Eurofins Packaging Testing Services assists clients in navigating complex regulatory landscapes, from raw materials to finished goods. Their goal is to enable businesses to bring safe, effective, and compliant products to market, enhancing consumer confidence and brand reputation.

Website: infinitylaboratories.com

HQ: New York, LUXEMBOURG

Countries: United States, Netherlands, Asia

Languages: English

Packaging Tests: Seal strength, Burst strength, Compression

Shelf-Life Methods: Accelerated aging

Standards: Other

Climate Chambers: Yes

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Intertek Packaging Testing

Intertek Packaging Testing offers quality solutions for packaging shelf-life testing, serving leading global brands and companies.

Intertek Packaging Testing is a trusted provider of comprehensive quality solutions, specializing in packaging shelf-life testing. They serve many of the world's leading brands and companies, ensuring product integrity and market readiness. For more information on their services and expertise, visit their website at www.intertek.com.

Website: genalysis.com.au

HQ: United States

Countries: United States, United Kingdom, Canada, Japan, Brazil

Languages: English

Packaging Tests: Package integrity, Seal strength, Burst strength

Shelf-Life Methods: Real-time aging, Accelerated aging, Both

Standards: ISTA

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SGS Packaging Testing

SGS-IPS Testing offers specialized packaging and shelf-life testing services for the packaging industry. Leverage their extensive experience and analytical capabilities to ensure product integrity and compliance.

SGS-IPS Testing is a leading provider of independent testing services for the paper, nonwovens, packaging, and consumer products industries. With nearly 40 years of experience, they offer reliable test information to help businesses make sound decisions and solve complex challenges. Their packaging testing services encompass a wide range of needs, including migration testing, odor analysis, and physical property evaluation. They are equipped to handle diverse testing requirements to ensure product quality and safety. SGS-IPS Testing is committed to providing comprehensive solutions. They offer a detailed Testing Service Capabilities List upon request and have a streamlined process for submitting samples. Their team is available to answer questions and guide clients through the testing process, ensuring efficient and accurate results.

Website: ipstesting.com

HQ: Appleton, US

Languages: English

Packaging Tests: Package integrity, Seal strength, Burst strength

Shelf-Life Methods: Accelerated aging, Real-time aging, Both

Standards: ISO 11607, ASTM D4169, ISTA

Climate Chambers: Yes

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Element Packaging Testing

Element Packaging Testing offers expert shelf-life testing services for food, supplements, and pet products. They provide scientifically validated expiration dates, stability analysis, and microbial challenge studies to ensure product quality, safety, and regulatory compliance.

Element Packaging Testing is a global leader in providing comprehensive shelf-life testing services, crucial for maximizing product quality and extending market reach. They offer scientifically validated expiration dates for a wide range of products, including foods, supplements, and pet products, across various storage conditions (frozen, refrigerated, ambient). Their services ensure product safety, maintain quality, and meet stringent regulatory and retailer requirements. Element's expertise covers stability analysis through microbiological, chemical, and physical testing, evaluating factors like spoilage indicators, water activity, pH levels, and rancidity. They also provide specialized microbial challenge studies to identify potential spoilage risks and validate safety parameters before product launch. With a global network of over 270 ISO 17025 accredited laboratories and 8,500 experts, Element delivers tailored testing protocols and clear communication. They support R&D initiatives, validate reformulations, and verify shelf-life extensions with scientifically robust methodologies, ensuring products are safe, compliant, and fit for purpose.

Website: element.com

HQ: US

Countries: United States, United Kingdom, Europe, Asia

Languages: English

Pricing model: Custom pricing

Packaging Tests: Other

Shelf-Life Methods: Accelerated aging, Real-time aging, Both

Standards: Other

Accredited: Yes

Climate Chambers: Yes

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Avomeen Analytical Services

Drug Development & Delivery is a leading publication and resource for professionals in the pharmaceutical and biotechnology industries, offering insights into drug development, delivery, and manufacturing.

Drug Development & Delivery serves as a vital resource for the pharmaceutical and biotechnology sectors, providing in-depth coverage of cutting-edge research, technologies, and services. The publication highlights core technologies, capabilities, and services offered by companies in areas such as analytical testing, formulation development, drug delivery systems, and contract manufacturing. It features expert insights on overcoming challenges in drug development, scaling manufacturing, and navigating regulatory landscapes. The platform is dedicated to advancing the understanding and application of innovative solutions in drug development and delivery, aiming to inform and connect industry professionals with the latest advancements and essential services. With a focus on practical applications and future trends, Drug Development & Delivery covers a wide spectrum of topics including purification strategies, CMC pitfalls, 3D printing in pharma, oral suspensions, injectable devices, and the development of novel therapeutics. The publication also emphasizes the importance of contract development and manufacturing organizations (CDMOs) in helping partners achieve their development goals. Through executive interviews and detailed company profiles, it offers a comprehensive overview of the industry's key players and their contributions to advancing medicine and patient care.

Website: avomeen.com

HQ: Netherlands

Languages: English

Packaging Tests: Other

Shelf-Life Methods: Accelerated aging

Standards: Other

Climate Chambers: Yes

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Smithers Pira

Smithers Pira offers expert packaging shelf life testing services. They provide comprehensive analysis to ensure product integrity and compliance.

Smithers Pira is a leading authority in packaging testing, offering specialized services for shelf life assessment within the packaging industry. Their expertise helps businesses understand and optimize the longevity of their products, ensuring they meet regulatory standards and consumer expectations. With a focus on the packaging shelf life testing directory, Smithers Pira leverages its deep knowledge and advanced testing methodologies to deliver reliable results. They work with clients to design and execute tailored testing programs, providing critical data that informs product development, supply chain management, and market readiness. Their commitment to scientific rigor ensures that clients receive actionable insights to enhance product performance and reduce waste. Their services are designed to support a wide range of packaging types and product categories, addressing challenges related to material degradation, environmental factors, and distribution conditions. By partnering with Smithers Pira, companies can gain confidence in their packaging solutions and extend the market viability of their goods.

Website: smithers.com

HQ: United Kingdom

Languages: English

Pricing model: Custom pricing

Rush Available: Yes

Packaging Tests: Package integrity, Seal strength, Burst strength

Shelf-Life Methods: Accelerated aging

Standards: ASTM D4169, ISTA

Accredited: Yes

Climate Chambers: Yes

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Labthink

Labthink provides advanced packaging testing equipment and services, specializing in gas permeability, OTR, WVTR, and shelf-life analysis for packaging materials.

Labthink International is a leading provider of packaging testing equipment and services, with headquarters in Jinan, China, and a presence in Boston, USA. They offer a comprehensive suite of solutions for the packaging industry, focusing on critical areas such as shelf-life testing, accelerated aging, and distribution testing. Their expertise includes the development and manufacturing of instruments for measuring oxygen transmission rate (OTR) and water vapor transmission rate (WVTR) of flexible packaging materials. These solutions are designed for high efficiency, allowing for simultaneous testing of multiple samples and providing fast, precise results. Labthink's equipment features smart control systems for full automation and stable temperature regulation, unaffected by environmental changes. Labthink also offers versatile testing capabilities for various gases like O2, N2, and CO2, supporting container testing and utilizing standard nitrogen as a carrier gas. Their product index includes specialized testers for permeability, evaporation residue, migration, tensile strength, and heat sealing, catering to diverse packaging material analysis needs and adhering to standards like ISO 11607.

Website: labthinkinternational.com

HQ: Jinan, China

Countries: China

Languages: English

Packaging Tests: Package integrity, Seal strength, Other

Shelf-Life Methods: Accelerated aging

Standards: ISO 11607, Other

Climate Chambers: Yes

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MOCON

AMETEK MOCON provides advanced gas measurement instruments and testing services for packaging, specializing in permeation and transmission rate analysis. They offer solutions for OTR, WVTR, and MAP testing.

AMETEK MOCON is a leading provider of precision gas permeation instruments and package testing services, serving industries for over 55 years. They offer a broad range of solutions, including analyzers for oxygen transmission rate (OTR) and water vapor transmission rate (WVTR) on films and packages, such as the OX-TRAN 2/22 and AQUATRAN 3/34. Their services extend to a world-class permeation laboratory, offering reliable permeation and package testing, including ISO/IEC 17025:2017 accredited testing for high-barrier samples. AMETEK MOCON also provides comprehensive support through their AMECare Performance Services, ensuring peak performance and minimal downtime for their instruments, which include MOCON, Dansensor, and Baseline product lines. They are committed to delivering accurate and repeatable results to help companies protect and enhance product quality and integrity.

Website: ametekmocon.com

HQ: USA

Countries: United States, Germany, China, Japan

Languages: English

Pricing model: Custom pricing

Packaging Tests: Package integrity

Shelf-Life Methods: Accelerated aging

Standards: Other

Accredited: Yes

Climate Chambers: Yes

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PTI Packaging Technologies & Inspection

PTI Packaging Technologies & Inspection offers advanced package integrity testing solutions, specializing in container closure integrity (CCI) for pharmaceutical, medical device, and food & beverage industries. They provide non-destructive testing equipment and services to ensure product safety and

PTI Packaging Technologies & Inspection is a leading global manufacturer of pharmaceutical package testing equipment, setting the industry standard for container closure integrity (CCI) testing. Their non-destructive inspection technologies are crucial for protecting the sterile barrier of high-risk medical device packaging and life-saving therapies in pharmaceutical containers. PTI offers solutions for biologics, cell & gene therapy products, and addresses the challenges of lighter weight and complex packaging formats in the food and beverage industry. Their expertise extends to nutritional products, where seal and package integrity are paramount for safety. Utilizing advanced methods like vacuum decay, which is substantiated by ASTM F2338 and referenced in ISO 11607 and USP, PTI's VeriPac instruments provide reliable, quantitative leak detection. They also offer specialized leak testing systems for bottles and containers, designed for inline operations and high reliability. PTI is committed to advancing sensory research and development to accelerate technological breakthroughs in package integrity testing.

Website: packagingtechtoday.com

HQ: US

Countries: United States, Germany, Europe

Languages: English

Packaging Tests: Package integrity, Seal strength

Standards: ISO 11607

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Steripack Group

Ensera offers comprehensive design and manufacturing services for medical and pharmaceutical devices, specializing in user-centric solutions from concept to final product. They focus on innovation, efficiency, and regulatory compliance.

Ensera, formerly SteriPack, is a global expert in medical and pharmaceutical device design and manufacturing. They provide end-to-end solutions, from initial concept development and research to prototyping, engineering, and final packaging. Their services are tailored to meet complex go-to-market challenges, emphasizing a user-centric approach, outside-the-box thinking, and a can-do mindset. The company excels in various design disciplines, including Research & Strategy, Human Factors, Industrial Design, Digital UX & UI Design, Engineering, and Electronics & Software. They focus on creating products that are not only innovative and functional but also safe, usable, and efficient, adhering to strict regulatory frameworks. Ensera's expertise extends to designing for manufacture, ensuring smooth production processes, waste reduction, and sustainability. With a strong emphasis on collaboration, Ensera partners with leading healthcare organizations to optimize existing devices or drive new product innovation. They are committed to delivering fresh thinking, impeccable service, and flexible solutions to help clients navigate the rapidly evolving healthcare landscape and achieve market success.

Website: ensera.com

HQ: St. Paul, US

Languages: English

Pricing model: Custom pricing

Rush Available: Yes

Packaging Tests: Package integrity, Seal strength, Burst strength

Shelf-Life Methods: Real-time aging, Accelerated aging, Both

Standards: ISO 11607, ISO 13485

Accredited: Yes

Climate Chambers: Yes

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Aptar Pharma

Aptar Pharma offers advanced packaging and drug delivery solutions, specializing in testing services to ensure product integrity and shelf life for pharmaceutical and biotech companies.

Aptar Pharma is a global leader in drug delivery, active packaging, and connected devices, providing innovative solutions for the pharmaceutical, biotech, and consumer healthcare industries. They offer specialized services in packaging and shelf-life testing, crucial for ensuring the efficacy and safety of pharmaceutical products. Their expertise helps clients meet stringent regulatory requirements and optimize product performance throughout its lifecycle. Leveraging extensive research and development capabilities, Aptar Pharma focuses on creating customized solutions that differentiate brands and enhance patient experience. Their manufacturing prowess ensures high-quality production of advanced drug delivery systems and packaging components. By partnering with Aptar Pharma, companies gain access to cutting-edge technology and a deep understanding of market needs, facilitating the successful launch and commercialization of their products.

Website: aptar.com

HQ: US

Countries: United States

Languages: English

Pricing model: Custom pricing

Packaging Tests: Package integrity, Seal strength, Burst strength

Shelf-Life Methods: Accelerated aging

Standards: ISO 11607, ASTM D4169, ISTA

Accredited: No

Climate Chambers: Yes

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ChemDAQ, Inc.

ChemDAQ provides advanced gas monitoring systems for sterilization and microbiology testing, ensuring workplace safety and regulatory compliance. They specialize in detecting EtO, H2O2, and PAA.

ChemDAQ is a leading provider of gas monitoring solutions, specializing in the detection of ethylene oxide (EtO), hydrogen peroxide (H2O2), and peracetic acid (PAA). Their systems are designed to ensure workplace safety and regulatory compliance in industries such as healthcare, medical device manufacturing, and food and beverage processing. With a focus on real-time monitoring, ChemDAQ's technology alerts users to unsafe gas levels, allowing for proactive intervention and risk mitigation. They offer a comprehensive solution including reliable monitoring equipment, sensor exchange programs, and exemplary customer support. Their commitment to quality and innovation has made them a trusted partner for organizations seeking to protect their teams and operations from hazardous gas exposure. ChemDAQ's expertise extends to providing continuous education and support, ensuring clients can effectively manage their monitoring needs. Their solutions are crucial for maintaining safe working environments and avoiding potential liabilities associated with gas exposure in critical sterilization and testing applications.

Website: chemdaq.com

HQ: Pittsburgh, US

Languages: English

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labequipment.com

Labequipment.com provides essential equipment for packaging and shelf-life testing. Discover a wide range of instruments to ensure product quality and compliance.

Labequipment.com is a dedicated provider of specialized equipment crucial for the packaging and shelf-life testing industries. We understand the critical need for accurate and reliable instruments to assess product integrity, determine expiration dates, and ensure compliance with regulatory standards. Our comprehensive catalog features a diverse selection of laboratory equipment designed to meet the rigorous demands of packaging and shelf-life analysis. Whether you are involved in food and beverage, pharmaceuticals, cosmetics, or industrial goods, Labequipment.com offers the tools you need to conduct thorough testing and maintain the highest quality standards. We are committed to supporting businesses in optimizing their product development and quality control processes. By providing access to state-of-the-art equipment, we empower our clients to make informed decisions, enhance product safety, and extend market viability through precise shelf-life determination.

Website: labequipment.com

Languages: English

Pricing model: Custom pricing

Packaging Tests: Package integrity, Seal strength, Burst strength

Shelf-Life Methods: Real-time aging, Accelerated aging, Both

Standards: ISO 11607, ASTM D4169, ISTA

Accredited: Yes

Climate Chambers: Yes

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TME Electronics

TME Electronics, part of Industrial Physics, offers innovative packaging testing equipment. They specialize in solutions for flexible, metal, and environmental packaging integrity.

TME Electronics, operating under the Industrial Physics umbrella, is a leading provider of advanced packaging testing equipment. Their expertise spans a wide range of testing solutions, including flexible packaging testing, metal packaging testing, and environmental testing equipment. They also offer specialized equipment for oxygen process testing, paints and coating inspection, paper and pulp testing, and physical property measurement. With a focus on innovation, TME provides equipment designed to ensure the integrity and quality of various packaging types. Their product offerings include leak and flow testers, smart package testers, and other sophisticated instruments crucial for quality control and product development in the packaging industry. Located in Telford, Shropshire, TME Electronics, through Industrial Physics, serves a global market. They are committed to delivering high-quality testing solutions and support to their clients, helping them meet stringent industry standards and customer expectations for packaging performance and shelf life.

Website: tmelectronics.com

HQ: Telford, GB

Languages: English

Pricing model: Custom pricing

Packaging Tests: Package integrity, Seal strength, Burst strength

Shelf-Life Methods: Accelerated aging

Standards: ISO 11607, ASTM D4169, ISTA

Accredited: Yes

Climate Chambers: Yes

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GlobalCompliance Solutions Pro

Leading global regulatory compliance consultancy serving medical device manufacturers worldwide with comprehensive regulatory services.

Website: globalcompliance-solutions.com

HQ: Boston, US

Jurisdictions: EU, UK, US

Countries: DE, FR, GB, US

Languages: English, French, German, Spanish

Response SLA: 24 hours

Onboarding time: 7–30 days

Pricing model: Custom pricing

Lead Time: Start in 2-4 weeks

Quote SLA: 24-48 hours

Rush Available: Yes

Packaging Tests: Package integrity, Seal strength, Burst strength

Shelf-Life Methods: Real-time aging, Accelerated aging, Both

Standards: ISO 11607, ASTM D4169, ISTA

Accredited: Yes

Climate Chambers: Yes

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MedReg International Pro

Specialized regulatory consultancy providing end-to-end compliance solutions for medical devices, IVDs, and combination products across all major markets.

Website: medreg-international.com

HQ: London, UK

Jurisdictions: EU, UK, US

Countries: DE, FR, GB, US

Languages: English, French, German, Spanish

Response SLA: 24 hours

Onboarding time: 7–30 days

Pricing model: Custom pricing

Lead Time: Start in 2-4 weeks

Quote SLA: 24-48 hours

Rush Available: Yes

Packaging Tests: Package integrity, Seal strength, Burst strength

Shelf-Life Methods: Real-time aging, Accelerated aging, Both

Standards: ISO 11607, ASTM D4169, ISTA

Accredited: Yes

Climate Chambers: Yes

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Regulatory Excellence Partners Pro

Boutique regulatory consultancy offering personalized, high-touch regulatory services for innovative medical device companies and startups.

Website: regulatoryexcellence.com

HQ: San Francisco, US

Jurisdictions: EU, UK, US

Countries: DE, FR, GB, US

Languages: English, French, German, Spanish

Response SLA: 24 hours

Onboarding time: 7–30 days

Pricing model: Custom pricing

Lead Time: Start in 2-4 weeks

Quote SLA: 24-48 hours

Rush Available: Yes

Packaging Tests: Package integrity, Seal strength, Burst strength

Shelf-Life Methods: Real-time aging, Accelerated aging, Both

Standards: ISO 11607, ASTM D4169, ISTA

Accredited: Yes

Climate Chambers: Yes

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Purple Diamond

The Purple Diamond package testing lab is located at 183 Mikron Road in Bethlehem, Pennsylvania, only 90 miles from New York City and 60 miles from Philadelphia

packaging shelf life testing: The Purple Diamond package testing lab is located at 183 Mikron Road in Bethlehem, Pennsylvania, only 90 miles from New York City and 60 miles from Philadelphia. We are proud to serve clients across the East Coast and beyond. To learn more or to schedule a tour of our lab, contact us using the form below. Ensuring the quality and consistency of your paper and corrugated packaging starts with accurate weight measurement. TAPPI T410 and TAPPI T844 are two key industry standards that provide critical data on material grammage, yet they serve distinct purposes. Want to optimize your packaging quality? Read on to discover how TAPPI Ensuring your product meets Amazon’s Ships in Own Container (SIOC) requirements can optimize logistics, reduce costs, and improve customer satisfaction. However, navigating the certification process can be challenging. Our team at Purple Diamond breaks down the key guidelines, testing protocols, and expert solutions to help you achieve compliance.

Website: purple-diamond.com

HQ: Bethlehem, US

Languages: English

Packaging Tests: Package integrity, Seal strength, Compression

Shelf-Life Methods: Accelerated aging

Standards: ISO 11607, ISTA, FDA Guidance

Accredited: Yes

Climate Chambers: Yes

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Ddltesting

Ddltesting offers specialized packaging shelf life testing services. They provide expert analysis to ensure your products meet quality and safety standards.

Ddltesting is a dedicated provider of packaging shelf life testing, crucial for ensuring product integrity and consumer safety. They leverage their expertise to conduct thorough analyses, helping businesses understand and validate the longevity of their packaged goods. Their services are designed to support manufacturers and distributors across various industries who need to comply with regulatory requirements and maintain high product quality. By partnering with Ddltesting, clients can gain confidence in their packaging solutions and extend their market reach with reliable shelf life data.

Website: ddltesting.com

Languages: English

Packaging Tests: Package integrity, Seal strength, Burst strength

Shelf-Life Methods: Real-time aging, Accelerated aging, Both

Standards: ASTM D4169, ISTA

Accredited: Yes

Climate Chambers: Yes

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Advanced Labs

Get comprehensive product testing for a wide variety of dietary supplements, nutraceuticals, personal care products, cosmetics, and more.

packaging shelf life testing: Get comprehensive product testing for a wide variety of dietary supplements, nutraceuticals, personal care products, cosmetics, and more. Stop overpaying for third-party testing and cut your time-to-results in half with a value-focused partner that prioritizes your ROI without sacrificing accuracy. Our ISO accredited labs offer a range of validated testing services for dietary supplements, nutraceuticals, personal care products, food, and cosmetics. Expert technicians analyze samples using industry best practices and validated testing methods to give you accurate results.

Website: advanced-labs.com

HQ: Salt Lake City, US

Languages: English

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Measurlabs

Our multidisciplinary team of testing experts and industry professionals provides personalized support to develop test plans tailored to your material and analytical needs while ensuring compliance with regulatory requirements.

packaging shelf life testing: Our multidisciplinary team of testing experts and industry professionals provides personalized support to develop test plans tailored to your material and analytical needs while ensuring compliance with regulatory requirements. Getting all the required tests in one place makes project coordination straightforward. All documents from offers to reports are always in the same format and easily accessible in our portal, where your team can seamlessly place and track orders. Your needs are always our priority. Through our vast network of hundreds of partner laboratories, we can accommodate your criteria for turnaround times, detection limits, testing standards, method accreditation, and more.

Website: measurlabs.com

HQ: Helsinki, FI

Languages: English

Quote SLA: < 24 hours

Packaging Tests: Other

Shelf-Life Methods: Accelerated aging

Standards: Other

Accredited: Yes

Climate Chambers: Yes

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Qesinc

Website: qesinc.com

Rush Available: Yes

Packaging Tests: Package integrity, Seal strength, Burst strength

Shelf-Life Methods: Real-time aging, Accelerated aging, Both

Standards: ASTM D4169, ISTA, ISO 11607

Accredited: Yes

Climate Chambers: Yes

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Amriglobal

Amriglobal offers expert packaging shelf life testing services, ensuring product integrity and compliance for your business.

Amriglobal specializes in comprehensive packaging shelf life testing solutions. We help businesses understand and validate the shelf life of their products, ensuring they meet regulatory requirements and consumer expectations. Our services are designed to protect your brand reputation and minimize product waste by providing accurate and reliable testing data. Partner with Amriglobal for your packaging and shelf life testing needs to guarantee product quality and safety throughout its lifecycle.

Website: amriglobal.com

Languages: English

Rush Available: Yes

Packaging Tests: Package integrity, Seal strength, Burst strength

Shelf-Life Methods: Real-time aging, Accelerated aging, Both

Standards: ISO 11607, ASTM D4169, ISTA

Accredited: Yes

Climate Chambers: Yes

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Vanderstahl

Vanderstahl offers specialized packaging shelf life testing services. They help ensure your products meet quality and regulatory standards.

Vanderstahl is a dedicated provider of packaging shelf life testing, crucial for ensuring product integrity and market readiness. Their expertise helps businesses understand how their packaging will perform over time, safeguarding against degradation and ensuring compliance with industry regulations. By leveraging advanced testing methodologies, Vanderstahl provides clients with reliable data on product stability and shelf life. This allows for informed decisions regarding product formulation, packaging design, and distribution strategies. Their services are essential for industries where product longevity and consumer safety are paramount. Partner with Vanderstahl to gain confidence in your product's shelf life and to optimize your packaging solutions for maximum effectiveness and market appeal.

Website: vanderstahl.com

Languages: English

Rush Available: Yes

Packaging Tests: Package integrity, Seal strength, Burst strength

Shelf-Life Methods: Real-time aging, Accelerated aging

Standards: ISO 11607, ASTM D4169, ISTA

Accredited: Yes

Climate Chambers: Yes

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Ista

ISTA is a member-based nonprofit that empowers organizations, and their people, to minimize product damage throughout distribution and optimize resource usage through effective package design

packaging shelf life testing: ISTA is a member-based nonprofit that empowers organizations, and their people, to minimize product damage throughout distribution and optimize resource usage through effective package design. Join Today! Registration is Open! The 2026 ISTA Forum USA, featuring the TransPack and TempPack events, is headed to the Sheraton Phoenix Downtown Hotel, April 7–9. Secure your sponsor exhibitor kiosk - spaces limited. Learn More ISTA Digital is a digital cloud application for ISTA members focused on collection and sharing of data, collaboration with stakeholders, and optimization of resources through effective package design. Plus, CONNECT is here! ISTA's powerful mobile-friendly collaboration tool, available to everyone at no charge. Sign Up Now

Website: ista.org

HQ: US

Languages: English

Packaging Tests: Package integrity, Vibration, Drop

Standards: ISTA

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Medicaldevicehq

Website: medicaldevicehq.com

Packaging Tests: Package integrity, Seal strength, Burst strength

Shelf-Life Methods: Real-time aging, Accelerated aging

Standards: ISO 11607, ASTM D4169, ISTA

Accredited: Yes

Climate Chambers: Yes

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Transittesting

Transittesting offers specialized packaging and shelf life testing services. They ensure your products meet regulatory and consumer expectations for durability and longevity.

Transittesting provides expert solutions for packaging and shelf life testing, crucial for ensuring product integrity and market readiness. Their services are designed to help businesses in the packaging industry validate the effectiveness of their packaging designs and predict product expiration dates accurately. With a focus on rigorous testing methodologies, Transittesting helps clients meet stringent industry standards and regulatory requirements. They understand the complexities of product degradation and the impact of various environmental factors on packaging performance. This allows them to offer tailored testing protocols that address specific product needs and market demands. Their expertise extends to a wide range of packaging materials and product types, ensuring comprehensive evaluation. By partnering with Transittesting, companies can gain confidence in their product's shelf stability, reduce waste, and enhance customer satisfaction through reliable product information.

Website: transittesting.com

Languages: English

Rush Available: Yes

Packaging Tests: Package integrity, Seal strength, Burst strength

Shelf-Life Methods: Real-time aging, Accelerated aging, Both

Standards: ISO 11607, ASTM D4169, ISTA

Accredited: Yes

Climate Chambers: Yes

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Qaiworld

packaging shelf life testing: The entirety of this site is protected by copyright © 2001– spaceship.com — 4600 East Washington Street, Suite 305, Phoenix, AZ 85034, USA The domain you are trying to purchase is listed on spaceship.com. You will now be redirected to Spaceship, where you can pay and finalize your purchase. Start using your domain right away and gain full ownership once all payments are complete!

Website: qaiworld.com

HQ: Phoenix, USA

Languages: English

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Comprehensive Buyer's Guide

1. Who Needs Packaging + Shelf-life Testing?

Medical devices with packaging or expiration dates must demonstrate packaging validation and shelf-life^[1]^[2]^[3].

This requirement applies to:

Sterile devices with packaging — devices that are sterilized and packaged must have validated packaging systems^[1]^[2]
Devices with expiration dates — devices with claimed shelf-life must demonstrate stability through aging studies^[2]
Devices for US market (FDA) — FDA requires packaging validation for sterile devices^[2] and shelf-life studies for devices with expiration dates^[2]
Devices for EU market (MDR) — MDR requires validation of packaging systems^[3]
Devices with new packaging — devices with new or modified packaging require validation^[1]
Devices with distribution requirements — devices that are shipped/distributed must demonstrate packaging can withstand distribution stresses^[4]
Devices with environmental sensitivity — devices sensitive to temperature, humidity, or light may require shelf-life studies^[2]

Note: The extent of testing required depends on device category, packaging type, claimed shelf-life, and regulatory pathway. A packaging validation plan helps determine which tests are needed. Some devices may be able to use prior data or packaging equivalency to reduce testing requirements.

References

ISO 11607:2019 — Packaging for terminally sterilized medical devices (International Organization for Standardization (ISO)) — 2019-12-01
FDA — Guidance for Industry and FDA Staff: Submission and Review of Sterility Information in Premarket Notification (510(k)) Submissions (U.S. Food and Drug Administration (FDA)) — 2008-06-01
Regulation (EU) 2017/745 on medical devices (MDR) (European Union) — 2017-04-05
ASTM D4169-22 — Standard Practice for Performance Testing of Shipping Containers and Systems (ASTM International) — 2022-01-01

2. What Services Are Typically Included?

Package integrity testing labs and packaging validation testing services typically include:

Package Integrity Testing (ISO 11607-2): Package integrity testing and packaging integrity testing to ensure packaging maintains sterility and device integrity per ISO 11607-2^[1] — includes visual inspection, dye penetration, bubble emission testing, and comprehensive package integrity evaluation at package integrity testing labs
Seal Integrity Testing (Including Pouch Seal Integrity Testing): Seal integrity testing and pouch seal integrity testing to measure seal strength and ensure seals meet specifications^[1] — critical for maintaining sterility barrier. Seal integrity testing methods include peel testing, burst testing, and visual inspection
Sterile Packaging Validation: Complete sterile packaging validation programs per ISO 11607 including design qualification, performance qualification, and validation testing^[1]
Packaging Validation Testing (ISO 11607 Testing): Comprehensive packaging validation testing and ISO 11607 testing including materials qualification, design validation, and process validation^[1]
Burst strength testing: Testing to measure package resistance to internal pressure^[1]
Compression testing: Testing to measure package resistance to compression forces^[1]
Real-time aging: Shelf-life studies under normal storage conditions over the claimed shelf-life period^[2] — typically takes the full claimed shelf-life duration (e.g., 2 years for a 2-year shelf-life)
Accelerated aging: Shelf-life studies using elevated temperature/humidity to simulate longer time periods^[2] — can reduce study duration (e.g., 3-6 months for a 2-year shelf-life)
Distribution simulation testing (ASTM D4169): Testing to simulate distribution stresses including vibration, shock, drop, compression, and climate variations^[3]
ISTA testing: International Safe Transit Association test methods for distribution simulation^[4]
Climate chamber testing: Testing under controlled temperature and humidity conditions for aging studies^[2]
Test reports: Comprehensive test reports suitable for regulatory submissions from package integrity testing labs

Additional services may include:

Packaging design consultation
Packaging material selection guidance
Stability testing and monitoring
Regulatory strategy and pathway guidance

References

ISO 11607:2019 — Packaging for terminally sterilized medical devices (International Organization for Standardization (ISO)) — 2019-12-01
FDA — Guidance for Industry and FDA Staff: Submission and Review of Sterility Information (U.S. Food and Drug Administration (FDA)) — 2008-06-01
ASTM D4169-22 — Standard Practice for Performance Testing of Shipping Containers and Systems (ASTM International) — 2022-01-01
ISTA — International Safe Transit Association Test Procedures (International Safe Transit Association (ISTA)) — 2024-01-01

3. What Affects Pricing?

Pricing for packaging + shelf-life testing varies based on several factors:

Testing scope: Packaging validation only is typically less expensive ($5,000 - $15,000) than full programs including shelf-life and distribution ($15,000 - $50,000+) — more tests = higher cost
Shelf-life method: Real-time aging is typically less expensive per test ($2,000 - $5,000) but takes the full shelf-life duration, while accelerated aging costs more per test ($5,000 - $15,000) but can be completed in 3-6 months^[1]
Claimed shelf-life: Longer shelf-life claims require longer studies — real-time aging for 5 years costs more than 2 years due to duration
Distribution testing: Distribution simulation testing (ASTM D4169, ISTA) adds cost ($3,000 - $10,000+) but is often required^[2]^[3]
Sample requirements: Number of samples needed varies by test type and shelf-life duration — more samples = higher material costs
Climate chamber requirements: Accelerated aging requires climate chambers — laboratories with in-house chambers may offer more cost-effective testing
Packaging complexity: Complex packaging or multiple packaging configurations may require custom test protocols, adding to cost
Prior data evaluation: If you have prior packaging/shelf-life data, laboratories can help evaluate its adequacy, potentially reducing testing needs — evaluation services may cost $2,000 - $5,000
Accreditation requirements: Accredited testing (ISO/IEC 17025) may cost more but is required for regulatory submissions
Lead time: Rush services (testing within 4-8 weeks) typically cost 20-50% more than standard lead times (8-16 weeks)
Regulatory support: Additional regulatory consulting or validation plan development may add $3,000 - $10,000

Typical pricing ranges:

Packaging validation only: $5,000 - $15,000
Real-time aging (2 years): $10,000 - $25,000
Accelerated aging (2-year equivalent): $8,000 - $20,000
Distribution simulation: $3,000 - $10,000
Full program (packaging + shelf-life + distribution): $20,000 - $60,000+

Tip: Request quotes from multiple laboratories and compare not just price, but also test scope, accreditation status, climate chamber capabilities, distribution testing methods, and lead times. Accredited test reports are essential for regulatory submissions.

References

FDA — Guidance for Industry and FDA Staff: Submission and Review of Sterility Information (U.S. Food and Drug Administration (FDA)) — 2008-06-01
ASTM D4169-22 — Standard Practice for Performance Testing of Shipping Containers and Systems (ASTM International) — 2022-01-01
ISTA — International Safe Transit Association Test Procedures (International Safe Transit Association (ISTA)) — 2024-01-01

4. How to Choose a Testing Laboratory

When selecting a packaging + shelf-life testing laboratory, consider these factors:

Packaging test coverage: Verify the laboratory offers all the packaging tests you need (package integrity, seal strength, burst strength, compression, vibration, drop, etc.)^[1] and can test per ISO 11607^[1]
Shelf-life method support: Determine if you need real-time aging, accelerated aging, or both^[2] — verify the laboratory supports your chosen method and can accommodate your claimed shelf-life duration
Climate chamber capabilities: For accelerated aging, verify the laboratory has climate chambers with appropriate temperature/humidity ranges and capacity for your sample size
Distribution testing: If you need distribution simulation, verify the laboratory offers ASTM D4169^[3] or ISTA^[4] testing and has the necessary equipment (vibration tables, drop testers, compression testers, etc.)
Accreditation status: Verify ISO/IEC 17025 accreditation^[5] and review the accreditation scope document to ensure your specific test methods (ISO 11607, ASTM D4169, etc.) are covered — accredited test reports are required for regulatory submissions
Standards support: Confirm the laboratory can test to the specific standards you need (ISO 11607^[1], ASTM D4169^[3], ISTA^[4], etc.)
Prior data evaluation: If you have prior packaging/shelf-life data, confirm the laboratory can help evaluate its adequacy and determine if additional testing is needed
Lead time and availability: Compare lead times (standard vs. rush) and availability windows — real-time aging takes the full shelf-life duration, while accelerated aging typically takes 3-6 months
Regulatory acceptance: Confirm test reports are accepted by your target regulatory authorities (FDA, EU notified bodies, etc.) — accredited laboratories generally provide reports suitable for multiple markets
Sample requirements: Understand sample requirements and whether samples are returned or disposed — affects total project cost
Response time and communication: Check quote response SLAs and communication quality — fast, clear communication is essential for project success
Pricing transparency: Look for laboratories that provide detailed quotes with clear breakdowns of included services, test methods, exclusions, and potential additional costs

Red flags: Laboratories that cannot provide accreditation scope documents, lack climate chambers for accelerated aging, cannot test to your required standards, or lack experience with your packaging type or device category.

References

ISO 11607:2019 — Packaging for terminally sterilized medical devices (International Organization for Standardization (ISO)) — 2019-12-01
FDA — Guidance for Industry and FDA Staff: Submission and Review of Sterility Information (U.S. Food and Drug Administration (FDA)) — 2008-06-01
ASTM D4169-22 — Standard Practice for Performance Testing of Shipping Containers and Systems (ASTM International) — 2022-01-01
ISTA — International Safe Transit Association Test Procedures (International Safe Transit Association (ISTA)) — 2024-01-01
ISO/IEC 17025:2017 — General requirements for the competence of testing and calibration laboratories (International Organization for Standardization (ISO)) — 2017-11-01

5. How Cruxi Quotes Work

Getting quotes through Cruxi is simple and fast:

Submit one request: Fill out a single form with your device details, packaging type, shelf-life needs, distribution requirements, timeline, and budget
Routed to Pro laboratories: Your request is automatically sent to Pro testing laboratories that match your requirements (typically 3-5 laboratories)
Compare quotes: Receive detailed quotes directly from laboratories and compare pricing, lead times, test scope, accreditation status, climate chamber capabilities, distribution testing methods, and included services

Benefits:

Save time by avoiding individual laboratory outreach
Compare multiple options side-by-side
Pro laboratories respond fastest (typically within 24-48 hours)
No obligation to accept any quote
Access to accredited laboratories with proven track records

Alternative: You can also request quotes directly from individual laboratories via their profile pages.

6. Listed vs Claimed vs Pro

Status	Meaning	RFQ Routing
Pro	Laboratory is Pro and opted in to receive RFQs	Included in multi-quote requests; responds fastest
Claimed	Laboratory has claimed their profile but is not Pro for RFQ routing	Direct requests only; not in multi-quote routing
Listed	Laboratory listed from public sources; profile not claimed	Manual contact required; not guaranteed to respond

Recommendation: For fastest response times and best quote comparison, prioritize Pro laboratories when requesting multiple quotes.

7. Onboarding Checklist (What Laboratories Typically Ask For)

To get accurate quotes and start testing efficiently, laboratories typically request:

Device information: Device name, category, class, intended use, and regulatory pathway
Packaging type: Primary, secondary, or tertiary packaging^[1] — affects test selection
Packaging materials: Complete material list including polymers, films, foils, adhesives, and any additives^[1]
Packaging validation needs: Which packaging tests you believe are needed (package integrity, seal strength, burst strength, compression, vibration, drop, etc.)^[1] — laboratories can help determine requirements
Shelf-life needs: Whether you need real-time or accelerated aging^[2], claimed shelf-life duration, and storage conditions
Distribution needs: Whether you need distribution simulation testing (ASTM D4169^[3], ISTA^[4]) and which distribution stresses are relevant
Target markets: Where you plan to market the device (US/FDA, EU/MDR, etc.)^[2]^[5]
Prior data: Any existing packaging validation or shelf-life data — may reduce testing requirements
Sample readiness: When samples will be available, how many units, and sample form
Timeline: Desired start date and any hard deadlines (e.g., regulatory submission deadline, market launch date) — note that real-time aging takes the full shelf-life duration
Attachments: Device specifications, packaging specifications, prior test reports, or other relevant documentation

Tip: More complete information leads to more accurate quotes and faster project kickoff. If you're unsure about test requirements, use the "Help me scope" option in the RFQ form — laboratories can help develop a packaging validation plan.

References

ISO 11607:2019 — Packaging for terminally sterilized medical devices (International Organization for Standardization (ISO)) — 2019-12-01
FDA — Guidance for Industry and FDA Staff: Submission and Review of Sterility Information (U.S. Food and Drug Administration (FDA)) — 2008-06-01
ASTM D4169-22 — Standard Practice for Performance Testing of Shipping Containers and Systems (ASTM International) — 2022-01-01
ISTA — International Safe Transit Association Test Procedures (International Safe Transit Association (ISTA)) — 2024-01-01
Regulation (EU) 2017/745 on medical devices (MDR) (European Union) — 2017-04-05

Frequently Asked Questions

Q1: What is package integrity testing and do I need a package integrity testing lab?

Package integrity testing (also called packaging integrity testing) verifies that medical device packaging maintains its sterility barrier and protects the device throughout shelf-life and distribution^[1]. Package integrity testing labs perform tests including visual inspection, dye penetration, bubble emission, and leak detection per ISO 11607-2^[1]. Package integrity testing is required for sterile medical devices to demonstrate the packaging maintains sterility^[2]. When searching for 'package integrity testing' or 'packaging integrity testing' providers, verify the laboratory is accredited for ISO 11607 testing and has experience with your packaging type (pouches, trays, etc.).

References

ISO 11607-2:2019 — Packaging for terminally sterilized medical devices — Part 2: Validation requirements (International Organization for Standardization (ISO)) — 2019-12-01
FDA — Guidance for Industry and FDA Staff: Submission and Review of Sterility Information (U.S. Food and Drug Administration (FDA)) — 2008-06-01

Q2: What is seal integrity testing and pouch seal integrity testing?

Seal integrity testing (including pouch seal integrity testing) measures the strength and quality of seals in medical device packaging^[1]. Seal integrity testing ensures that seals maintain their integrity throughout shelf-life and distribution, preventing contamination and maintaining sterility. Common seal integrity testing methods include: peel testing (measures force required to separate seal), burst testing (measures seal resistance to internal pressure), visual inspection (detects seal defects), and dye penetration (detects seal leaks)^[1]. Pouch seal integrity testing is specifically critical for flexible pouch packaging, which is common for sterile medical devices. Package integrity testing labs perform seal integrity testing as part of ISO 11607 validation programs^[1].

References

ISO 11607-2:2019 — Packaging for terminally sterilized medical devices — Part 2: Validation requirements (International Organization for Standardization (ISO)) — 2019-12-01

Q3: What is sterile packaging validation and ISO 11607 testing?

Sterile packaging validation (also called packaging validation testing or ISO 11607 testing) is the process of demonstrating that packaging systems for terminally sterilized medical devices maintain sterility and device integrity^[1]. ISO 11607 is the international standard that defines requirements for packaging systems^[1]. ISO 11607-2 specifically covers validation requirements including package integrity testing, seal integrity testing, and performance testing^[1]. Sterile packaging validation programs typically include: materials qualification, design validation, process validation, and performance testing. Package integrity testing labs perform ISO 11607 testing to ensure packaging meets regulatory requirements for FDA 510(k), CE marking, and other regulatory submissions^[2].

References

ISO 11607:2019 — Packaging for terminally sterilized medical devices (International Organization for Standardization (ISO)) — 2019-12-01
FDA — Guidance for Industry and FDA Staff: Submission and Review of Sterility Information (U.S. Food and Drug Administration (FDA)) — 2008-06-01

Q4: What is packaging validation and why do I need it?

Packaging validation demonstrates that your packaging system maintains sterility and device integrity throughout distribution and storage^[1]^[2]. Validation typically includes package integrity testing, seal integrity testing, and distribution simulation^[1]. Validation is required for sterile devices with packaging^[1]^[2]^[3]. Regulatory authorities (FDA, EU MDR, etc.) require packaging validation testing to demonstrate that packaging maintains sterility and protects the device^[2]^[3]. The extent of validation depends on packaging type, device category, and regulatory pathway.

References

ISO 11607:2019 — Packaging for terminally sterilized medical devices (International Organization for Standardization (ISO)) — 2019-12-01
FDA — Guidance for Industry and FDA Staff: Submission and Review of Sterility Information (U.S. Food and Drug Administration (FDA)) — 2008-06-01
Regulation (EU) 2017/745 on medical devices (MDR) (European Union) — 2017-04-05

Q5: What's the difference between real-time and accelerated aging?

Real-time aging studies the device under normal storage conditions over the claimed shelf-life period^[1]. For a 2-year shelf-life, real-time aging takes 2 years. Real-time aging is typically less expensive per test but requires the full shelf-life duration. Accelerated aging uses elevated temperature/humidity to simulate longer time periods^[1]. For a 2-year shelf-life, accelerated aging typically takes 3-6 months. Accelerated aging costs more per test but can be completed much faster. FDA accepts both methods^[1], but accelerated aging requires validation of the acceleration factor. Many laboratories offer both methods. Real-time aging is often preferred for complex devices or when acceleration factors are uncertain.

References

FDA — Guidance for Industry and FDA Staff: Submission and Review of Sterility Information (U.S. Food and Drug Administration (FDA)) — 2008-06-01

Q6: Do I need distribution testing?

Distribution testing simulates distribution stresses including vibration, shock, drop, compression, and climate variations^[1]^[2]. Distribution testing is: Often required for devices that are shipped/distributed^[1]^[2]; Valuable for demonstrating packaging can withstand distribution stresses; Required for some regulatory pathways; and Useful for identifying packaging weaknesses before market launch. ASTM D4169^[1] and ISTA^[2] provide standard test methods for distribution simulation. Distribution testing adds cost ($3,000 - $10,000+) but is often required for regulatory submissions. Some laboratories offer distribution testing, while others focus on packaging/shelf-life only.

References

ASTM D4169-22 — Standard Practice for Performance Testing of Shipping Containers and Systems (ASTM International) — 2022-01-01
ISTA — International Safe Transit Association Test Procedures (International Safe Transit Association (ISTA)) — 2024-01-01

Q7: Which packaging tests do I need?

The required packaging tests depend on packaging type, device category, and regulatory pathway. Common tests: Package integrity — visual inspection, dye penetration, bubble emission^[1]; Seal strength — measurement of seal strength^[1]; Burst strength — package resistance to internal pressure^[1]; Compression — package resistance to compression forces^[1]; Vibration — package resistance to vibration^[1]; Drop — package resistance to drop impacts^[1]. ISO 11607^[1] provides requirements for packaging validation. A packaging validation plan helps determine which tests are needed. Many laboratories offer validation plan development services to help you determine which tests are required.

References

ISO 11607:2019 — Packaging for terminally sterilized medical devices (International Organization for Standardization (ISO)) — 2019-12-01

Q8: How long does packaging + shelf-life testing take?

Testing timelines vary by test type, shelf-life duration, and laboratory capacity. Typical timelines: Packaging validation: 4-8 weeks; Real-time aging: Takes the full shelf-life duration (e.g., 2 years for a 2-year shelf-life); Accelerated aging: 3-6 months for a 2-year equivalent; Distribution simulation: 2-4 weeks. Total project time: Packaging validation only: 4-8 weeks; With real-time aging: Full shelf-life duration (e.g., 2 years); With accelerated aging: 3-6 months; With distribution: Add 2-4 weeks. Factors affecting timeline include: Shelf-life method (real-time takes the full duration, accelerated is faster), shelf-life duration (longer claims = longer studies), laboratory backlog, sample preparation time, and retest needs (if initial tests reveal issues). Rush services (packaging validation within 2-4 weeks) are available at most laboratories but typically cost 20-50% more. Plan for 4-8 weeks for packaging validation, plus shelf-life duration for aging studies.

Q9: What samples do I need to provide?

Sample requirements vary by test type, shelf-life duration, and device type. Typical requirements: Packaging validation: Finished packaged devices (often 20-50 samples, depending on test design); Real-time aging: Finished packaged devices (often 30-100+ samples, depending on shelf-life duration and test intervals); Accelerated aging: Finished packaged devices (often 20-50 samples, depending on test design); Distribution simulation: Finished packaged devices (often 10-30 samples, depending on test design). Some tests can use packaging samples, while others require finished devices. Laboratories typically provide detailed sample requirements in their quotes. Samples are usually not returned (disposed after testing) unless specifically requested. More complex devices or packaging may require additional samples.

Q10: Can I use prior packaging/shelf-life data?

Prior packaging/shelf-life data can be used if: The data is from the same or equivalent packaging system^[1]; The data was generated using appropriate test methods (ISO 11607, etc.)^[1]; The data is recent and still valid (typically within 5-10 years, depending on packaging stability); and The data covers the required tests for your device's packaging type and regulatory pathway. Packaging equivalency can also reduce testing — if your packaging is equivalent to previously tested packaging, you may be able to use prior data. Many laboratories offer prior data evaluation services ($2,000 - $5,000) to assess whether your existing data is adequate or if additional testing is needed. Using prior data can significantly reduce cost and timeline.

References

ISO 11607:2019 — Packaging for terminally sterilized medical devices (International Organization for Standardization (ISO)) — 2019-12-01

Q11: What if my packaging fails testing?

If your packaging fails initial testing, most laboratories offer failure analysis and consultation to help identify issues and potential solutions. Common failure modes include: Package integrity failures (may indicate seal issues or material incompatibility), seal strength failures (may indicate seal process issues), burst strength failures (may indicate package design issues), compression failures (may indicate package strength issues), or distribution failures (may indicate packaging not suitable for distribution). Laboratories typically provide detailed failure analysis and recommendations. You may need to: Modify packaging materials or design, adjust seal processes, improve packaging configuration, or retest after modifications. Retesting typically costs 50-75% of original test cost. Pre-test packaging characterization can help identify potential issues before formal validation.

Q12: Do I need both packaging validation and shelf-life testing?

Packaging validation demonstrates that packaging maintains sterility and device integrity^[1]^[2]. Shelf-life testing demonstrates device stability over time^[2]. You may need both if: Your device is sterile and has an expiration date (requires both packaging validation and shelf-life); Your device is sterile but has no expiration date (may only need packaging validation); Your device has an expiration date but is not sterile (may only need shelf-life). The requirements depend on device category, regulatory pathway, and labeling. Consult with a testing laboratory or regulatory consultant to determine which tests are needed. Many laboratories offer both packaging validation and shelf-life testing, and combined packages can be more cost-effective.

References

ISO 11607:2019 — Packaging for terminally sterilized medical devices (International Organization for Standardization (ISO)) — 2019-12-01
FDA — Guidance for Industry and FDA Staff: Submission and Review of Sterility Information (U.S. Food and Drug Administration (FDA)) — 2008-06-01

Q13: What should I include in an RFQ to get accurate quotes?

To get accurate, comparable quotes, include: Device details: name, category, class, intended use; Packaging type: primary, secondary, or tertiary^[1]; Packaging materials: complete material list; Packaging validation needs: which tests you believe are needed (laboratories can help determine)^[1]; Shelf-life needs: whether you need real-time or accelerated aging^[2], claimed shelf-life duration; Distribution needs: whether you need distribution simulation (ASTM D4169^[3], ISTA^[4]); Target markets: US/FDA, EU/MDR, etc.^[2]^[5]; Prior data: any existing packaging/shelf-life data; Sample readiness: when samples will be available, how many units; Timeline: desired start date and any hard deadlines (note that real-time aging takes the full shelf-life duration); Budget range: to help laboratories provide appropriate options. Attach device specifications, packaging specifications, prior test reports, or other relevant documentation.

References

ISO 11607:2019 — Packaging for terminally sterilized medical devices (International Organization for Standardization (ISO)) — 2019-12-01
FDA — Guidance for Industry and FDA Staff: Submission and Review of Sterility Information (U.S. Food and Drug Administration (FDA)) — 2008-06-01
ASTM D4169-22 — Standard Practice for Performance Testing of Shipping Containers and Systems (ASTM International) — 2022-01-01
ISTA — International Safe Transit Association Test Procedures (International Safe Transit Association (ISTA)) — 2024-01-01
Regulation (EU) 2017/745 on medical devices (MDR) (European Union) — 2017-04-05

Provider Comparison Table

Provider	Packaging Tests	Shelf-Life Methods	Standards	Accredited	Climate Chambers	Distribution Simulation	Lead Time	Quote SLA	Regions Served	Languages	Response SLA
Eurofins Medical Device Testing	—	—	—	No	No	No	—	—	—	English	Request quote
Smithers	Package integrity, Seal strength, Burst strength	Accelerated aging	ISTA, ISO 11607	No	Yes	Yes	—	—	—	English	Request quote
Westpak	Package integrity, Other	Accelerated aging, Both	ISTA, Other	No	No	Yes	—	—		English	Request quote
DDL, Inc.	Package integrity, Seal strength, Burst strength	Accelerated aging	ISO 11607, ASTM D4169, ISTA	Yes	Yes	Yes	—	—	—	English	Request quote
Life Science Outsourcing, Inc.	—	—	—	No	No	No	—	—	—	English	Request quote
Infinity Laboratories	—	—	—	No	No	No	—	—	—	English	Request quote
Eurofins Medical Device Testing	Package integrity, Seal strength, Burst strength	Real-time aging, Accelerated aging, Both	ISO 11607, ISO 16775, Other	No	Yes	Yes	—	—	Czech Republic, Netherlands, New Zealand	English	Request quote
UL Solutions	Package integrity, Seal strength, Burst strength	Real-time aging, Accelerated aging, Both	Other	No	Yes	Yes	—	—		English	Request quote
Intertek	Package integrity, Seal strength, Burst strength	Real-time aging, Accelerated aging, Both	ISO 11607, ASTM D4169, ISTA	Yes	Yes	Yes	—	—	—	English	Request quote
SGS	Other	Accelerated aging	Other	Yes	Yes	Yes	—	—	USA, CANADA	English	Request quote

Sources & Official Guidance

Official sources vary by directory. See the applicable regulation and competent authority guidance for this role.

Last Updated: 2026-02-04

Reviewed by: Cruxi Regulatory Affairs Team

Best Package Integrity & Seal Integrity Testing Labs for Medical Devices

Compare Packaging + Shelf-life + Distribution Testing Providers

GlobalCompliance Solutions Pro

MedReg International Pro

Regulatory Excellence Partners Pro

Comprehensive Buyer's Guide

1. Who Needs Packaging + Shelf-life Testing?

References

2. What Services Are Typically Included?

References

3. What Affects Pricing?

References

4. How to Choose a Testing Laboratory

References

5. How Cruxi Quotes Work

6. Listed vs Claimed vs Pro

7. Onboarding Checklist (What Laboratories Typically Ask For)

References

Frequently Asked Questions

Q1: What is package integrity testing and do I need a package integrity testing lab?

References

Q2: What is seal integrity testing and pouch seal integrity testing?

References

Q3: What is sterile packaging validation and ISO 11607 testing?

References

Q4: What is packaging validation and why do I need it?

References

Q5: What's the difference between real-time and accelerated aging?

References

Q6: Do I need distribution testing?

References

Q7: Which packaging tests do I need?

References

Q8: How long does packaging + shelf-life testing take?

Q9: What samples do I need to provide?

Q10: Can I use prior packaging/shelf-life data?

References

Q11: What if my packaging fails testing?

Q12: Do I need both packaging validation and shelf-life testing?

References

Q13: What should I include in an RFQ to get accurate quotes?

References

Related Regulatory Services

Provider Comparison Table

Sources & Official Guidance