Packaging Compliance Labs
★★★★★
4.5
/ 5
•
11 reviews
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.
About
**Who they are**
Packaging Compliance Labs is an ISO 17025-accredited facility specializing in medical device packaging testing, contract packaging, and engineering services. They are dedicated to helping medical device manufacturers ensure compliance and accelerate their path to market.
**Expertise & scope**
* Comprehensive package testing, including transit/distribution simulations, shelf-life studies, and sterile barrier integrity tests, all performed in an ISO 17025-accredited facility.
* Contract packaging services offered in an ISO Class 7 cleanroom for low- to medium-volume projects, including kitting, assembly, labeling, sterile packaging, and documentation.
* Packaging engineering support to assist at any stage of the packaging process, ensuring compliance with ISO 11607 for terminally sterilized medical device packaging.
* Specialized services like CompliancePack™ (CPack), an expedited sterile packaging solution designed to meet ISO 11607 requirements and accelerate device launch timelines.
**Reputation / proof points**
* ISO 17025-accredited facility for all medical package testing.
* ISO Class 7 cleanroom facility for contract packaging.
* ISO 13485-certified for contract packaging services.
* Expertise in ISO 11607 compliance.
Packaging Compliance Labs is an ISO 17025-accredited facility specializing in medical device packaging testing, contract packaging, and engineering services. They are dedicated to helping medical device manufacturers ensure compliance and accelerate their path to market.
**Expertise & scope**
* Comprehensive package testing, including transit/distribution simulations, shelf-life studies, and sterile barrier integrity tests, all performed in an ISO 17025-accredited facility.
* Contract packaging services offered in an ISO Class 7 cleanroom for low- to medium-volume projects, including kitting, assembly, labeling, sterile packaging, and documentation.
* Packaging engineering support to assist at any stage of the packaging process, ensuring compliance with ISO 11607 for terminally sterilized medical device packaging.
* Specialized services like CompliancePack™ (CPack), an expedited sterile packaging solution designed to meet ISO 11607 requirements and accelerate device launch timelines.
**Reputation / proof points**
* ISO 17025-accredited facility for all medical package testing.
* ISO Class 7 cleanroom facility for contract packaging.
* ISO 13485-certified for contract packaging services.
* Expertise in ISO 11607 compliance.
Additional information
Packaging Compliance Labs provides a comprehensive approach to medical device packaging, from initial engineering and testing to full-service contract packaging. Their services are designed to streamline the product launch process, particularly for small batch needs. They emphasize a concept-to-validation process that aims to reduce risk and save time for manufacturers. Engagement typically involves close collaboration to ensure all regulatory requirements, such as ISO 11607, are met. Their facility is equipped to handle various testing simulations and cleanroom packaging operations.
Key Highlights
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Offers ISO 17025-accredited medical package testing, including transit, shelf-life, and sterile barrier integrity tests.
Source
“All medical package testing is done in our ISO 17025-accredited state-of-the-art facility.”
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Provides contract packaging services in an ISO Class 7 cleanroom for low- to medium-volume projects.
Source
“Our ISO Class 7 cleanroom facility is customized for low- to medium-volume contract packaging projects.”
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Specializes in ensuring compliance with ISO 11607 for terminally sterilized medical device packaging.
Source
“We help ensure compliance with ISO 11607 for validating terminally sterilized medical device packaging.”
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Offers CompliancePack™ (CPack), an expedited sterile packaging solution to accelerate device launch timelines.
Source
“CompliancePack™ (CPack) is an expedited sterile packaging solution developed by Packaging Compliance Labs (PCL), designed specifically to meet ISO 11607 requirements.”
Certifications & Trust Signals
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Operates an ISO 17025-accredited facility for package testing.
Source
“All medical package testing is done in our ISO 17025-accredited state-of-the-art facility.”
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Provides ISO 13485-certified contract packaging services.
Source
“Medical device manufacturers rely on Packaging Compliance Labs for turnkey, ISO 13485–certified contract packaging services”
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Utilizes an ISO Class 7 cleanroom for contract packaging operations.
Source
“Our ISO Class 7 cleanroom facility is customized for low- to medium-volume contract packaging projects.”
Buyer Snapshot
Best for
- Medical device manufacturers needing ISO 11607 compliant packaging validation.
- Companies requiring specialized contract packaging in a cleanroom environment.
- Businesses seeking to accelerate product launches through expedited packaging solutions.
How engagement typically works
- Collaborative partnership for testing and engineering.
- Turnkey solution for contract packaging needs.
- Consultative approach to compliance challenges.
Typical deliverables
- Package validation reports.
- Shelf-life study results.
- Sterile barrier integrity test data.
- Packaged medical devices ready for sterilization and distribution.
- Engineering design and validation support.
Good to know
- Best when requiring ISO 17025 accredited testing.
- Best when needing ISO Class 7 cleanroom services for packaging.
- Best when aiming to meet ISO 11607 standards.
Pricing
Model:
Custom pricing
HQ:
Boulder, US
Languages:
English
Timezones:
America/Denver
Claim status:
Listed
Services & Capabilities
Packaging + Shelf-life + Distribution Testing
Countries:
United States
Industries:
Medical Devices
Pricing model:
Custom pricing
Packaging Tests Offered:
Package integrity, Seal strength, Drop, Other
Shelf Life Methods Offered:
Real-time aging, Accelerated aging, Both
Distribution Tests Offered:
Drop, Climate, Other
Standards Supported:
ISO 11607, FDA Guidance, Other
Is Accredited:
Yes
Accreditation Body:
ISO
Has Climate Chambers:
Yes
Has Distribution Simulation:
Yes
Rush Available:
No
Nda Support:
No
Lead Time Band:
Start in 2-4 weeks
Minimum Project Size:
No minimum
Quote SLA:
< 24 hours
Sample Return Policy:
Dispose
Additional packaging_shelf_life_testing Details
Packaging Tests Offered
Transit Testing, Shelf-Life Testing, Sterile Barrier Package Integrity, Material + Label Testing, Transit/distribution simulations, Sterile barrier integrity tests
Standards Supported
ISO 11607, ISO 13485
Shelf Life Methods Offered
Real-time aging, Accelerated aging
Distribution Tests Offered
Transit/distribution simulations
Lead Time Band
Start in 0-2 weeks
Quote SLA
< 24 hours
Sample Return Policy
Dispose
Minimum Project Size
No minimum
Pricing Model
Per project
