Eurofins Packaging Testing Services
Eurofins Scientific
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.
About
**Who they are**
Eurofins Packaging Testing Services, operating as Infinity Laboratories, provides comprehensive analytical testing and consulting services for the pharmaceutical and medical device industries. They focus on ensuring product quality, safety, and regulatory compliance throughout the product lifecycle.
**Expertise & scope**
* Analytical Method Development & Validation: Creating and validating methods for various analytical techniques.
* Chemical & Physical Testing: Including wet chemistry techniques like titration and gravimetric analysis, appearance evaluation, and chromatography.
* Stability Testing: Conducting studies (real-time, accelerated, forced degradation) to determine storage conditions and shelf life, adhering to ICH guidelines.
* Microbiology Testing: Assessing microbial contamination risks, performing method development, validation, and testing for nonsterile and injectable products, including antimicrobial effectiveness and endotoxin testing.
* Sterility Assurance Testing: Supporting sterility of medical devices and pharmaceutical products through method development, sterilization validation, and bioburden testing.
* Container & Closure Testing: Evaluating container material compatibility, extractables and leachables, and closure integrity to ensure product protection and sterility.
* Water Testing: Analyzing all grades of water for pharmaceutical use according to USP-NF, EP, and JP standards.
**Reputation / proof points**
* Operates under GMP compliance and adheres to standards set by leading regulatory agencies.
* Utilizes state-of-the-art instrumentation and highly experienced professionals.
* Network of nationwide labs offering flexibility and national resources.
* Services guided by standards from organizations including USP-NF, EP, JP, ICH, ISO, ASTM, and AAMI.
Eurofins Packaging Testing Services, operating as Infinity Laboratories, provides comprehensive analytical testing and consulting services for the pharmaceutical and medical device industries. They focus on ensuring product quality, safety, and regulatory compliance throughout the product lifecycle.
**Expertise & scope**
* Analytical Method Development & Validation: Creating and validating methods for various analytical techniques.
* Chemical & Physical Testing: Including wet chemistry techniques like titration and gravimetric analysis, appearance evaluation, and chromatography.
* Stability Testing: Conducting studies (real-time, accelerated, forced degradation) to determine storage conditions and shelf life, adhering to ICH guidelines.
* Microbiology Testing: Assessing microbial contamination risks, performing method development, validation, and testing for nonsterile and injectable products, including antimicrobial effectiveness and endotoxin testing.
* Sterility Assurance Testing: Supporting sterility of medical devices and pharmaceutical products through method development, sterilization validation, and bioburden testing.
* Container & Closure Testing: Evaluating container material compatibility, extractables and leachables, and closure integrity to ensure product protection and sterility.
* Water Testing: Analyzing all grades of water for pharmaceutical use according to USP-NF, EP, and JP standards.
**Reputation / proof points**
* Operates under GMP compliance and adheres to standards set by leading regulatory agencies.
* Utilizes state-of-the-art instrumentation and highly experienced professionals.
* Network of nationwide labs offering flexibility and national resources.
* Services guided by standards from organizations including USP-NF, EP, JP, ICH, ISO, ASTM, and AAMI.
Additional information
Infinity Laboratories emphasizes rigorous method development and validation, crucial for ensuring the reliability of test results across diverse pharmaceutical and medical device products. Their approach integrates seamlessly from early development through commercial production, acting as an extension of the client's team. They are adept at handling complex analyses, including those for highly sensitive drug products and ensuring the microbiological integrity of sterile packaging. Buyers should consider engaging Infinity Laboratories early in the development process to leverage their expertise in designing appropriate testing strategies and establishing robust quality control measures.
Key Highlights
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Offers comprehensive analytical chemistry, physical testing, and method development/validation services.
Source
“Infinity supports analytical method development for a wide range of analytical techniques and products, and we provide method validation services”
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Provides detailed stability testing, including real-time, accelerated, and forced degradation studies.
Source
“Infinity Laboratories stores samples in our GMP-compliant stability chambers and conducts the required testing at specified intervals.”
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Conducts extensive microbiology and sterility assurance testing for pharmaceutical products and medical devices.
Source
“Microbiological testing is vital to assure the lack of microorganisms such as specific pathogens, bacteria, yeast, and molds.”
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Specializes in container testing, including material compatibility, extractables/leachables, and closure integrity.
Source
“Thorough analysis is required to ensure that specified containers meet quality, safety, and regulatory standards.”
Certifications & Trust Signals
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Operates under strict compliance with GMP and other regulatory standards.
Source
“Operating under the governance of our internal quality assurance group, we assure strict compliance with GMP and other regulatory standards.”
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Adheres to standards set by world-leading regulatory agencies and pharmacopeias (USP-NF, EP, JP).
Source
“Infinity offers comprehensive wet chemistry testing services to characterize drug products based on standards set by the world’s leading standards organizations, including United States Pharmacopeia – National Formulary (USP-NF), European Pharmacopoeia (EP), and Japanese Pharmacopoeia (JP).”
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Conducts testing under standards set by the United States, European, and Japanese pharmacopeias and standards bodies, including ISO, ASTM, and AAMI.
Source
“All tests are conducted under standards set by the United States, European, and Japanese pharmacopeias and standards bodies, including the ISO, ASTM, and AAMI.”
Buyer Snapshot
Best for
- Companies seeking to validate product shelf-life and packaging integrity.
- Businesses needing to ensure regulatory compliance for packaging.
- Manufacturers aiming to meet global market standards for their products.
How engagement typically works
- Consultative approach to testing and compliance.
- Support for meeting specific market standards.
Typical deliverables
- Shelf-life testing reports.
- Packaging compliance assessments.
- Consulting on packaging optimization.
Good to know
- Best when requiring specialized packaging and shelf-life testing expertise.
HQ:
New York, LUXEMBOURG
Languages:
English
Timezones:
EST
Claim status:
Listed
Services & Capabilities
Packaging + Shelf-life + Distribution Testing
Countries:
United States, Netherlands, Asia
Industries:
Medical Devices
Pricing model:
Custom pricing
Packaging Tests Offered:
Package integrity, Other
Shelf Life Methods Offered:
Both
Distribution Tests Offered:
Vibration, Drop, Climate, Other
Standards Supported:
FDA Guidance, Other
Has Climate Chambers:
Yes
Has Distribution Simulation:
Yes
Regions Served:
Czech Republic, Netherlands, New Zealand, Philippines, Switzerland, United Kingdom, UNITED ARAB EMIRATES, United States
Lead Time Band:
Start in 2-4 weeks
Quote SLA:
3-5 business days
Sample Return Policy:
Dispose
Minimum Project Size:
$10-25k
Additional packaging_shelf_life_testing Details
Packaging Tests Offered
Package integrity, Shelf-life testing
Standards Supported
Global market standards
Shelf Life Methods Offered
Real-time aging, Accelerated aging
Distribution Tests Offered
N/A
Lead Time Band
Start in 0-2 weeks
Quote SLA
24-48 hours
Sample Return Policy
Return
Minimum Project Size
$10-25k
Pricing Model
Per project
