Packaging Compliance Labs
★★★★★
4.4
/ 5
•
10 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 a specialized provider of packaging testing, contract packaging, and engineering services for medical devices. They are dedicated to ensuring compliance with critical industry standards and accelerating the path to market for their clients.
**Expertise & scope**
* Expert package testing, including transit/distribution simulations, shelf life, and sterile barrier integrity tests.
* Contract packaging services offered in an ISO Class 7 cleanroom facility, catering to low- to medium-volume projects.
* Packaging engineering support, assisting at any stage of the packaging process.
* Ensuring compliance with ISO 11607 for validating terminally sterilized medical device packaging.
* Specialized services like CompliancePack™ (CPack) for expedited sterile packaging solutions.
**Reputation / proof points**
* Operates a state-of-the-art facility accredited to ISO 17025.
* Offers services within an ISO Class 7 cleanroom facility.
* Provides services within an ISO 13485-certified contract packaging operation.
* Has an office located in Boulder, CO.
Packaging Compliance Labs is a specialized provider of packaging testing, contract packaging, and engineering services for medical devices. They are dedicated to ensuring compliance with critical industry standards and accelerating the path to market for their clients.
**Expertise & scope**
* Expert package testing, including transit/distribution simulations, shelf life, and sterile barrier integrity tests.
* Contract packaging services offered in an ISO Class 7 cleanroom facility, catering to low- to medium-volume projects.
* Packaging engineering support, assisting at any stage of the packaging process.
* Ensuring compliance with ISO 11607 for validating terminally sterilized medical device packaging.
* Specialized services like CompliancePack™ (CPack) for expedited sterile packaging solutions.
**Reputation / proof points**
* Operates a state-of-the-art facility accredited to ISO 17025.
* Offers services within an ISO Class 7 cleanroom facility.
* Provides services within an ISO 13485-certified contract packaging operation.
* Has an office located in Boulder, CO.
Additional information
Packaging Compliance Labs emphasizes a concept-to-validation process designed to reduce risk and save time for medical device manufacturers. Their contract packaging services are particularly suited for overcoming small batch challenges, offering a turnkey solution that includes kitting, assembly, sterile barrier packaging, labeling, sealing, and documentation. The CompliancePack™ (CPack) solution is highlighted as a method to significantly accelerate device launch timelines, potentially saving months in development and validation. They manage all aspects of packaging and sealing within their ISO Class 7 cleanroom, ensuring devices meet regulatory requirements and are shelf-ready.
Key Highlights
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Offers package testing services in an ISO 17025-accredited facility.
Source
“All medical package testing is done in our ISO 17025-accredited state-of-the-art facility.”
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Provides contract packaging in an ISO Class 7 cleanroom.
Source
“Our ISO Class 7 cleanroom facility is customized for low- to medium-volume contract packaging projects.”
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Specializes in ISO 11607 compliance for 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) for expedited sterile packaging.
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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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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ISO Class 7 cleanroom for contract packaging.
Source
“Our ISO Class 7 cleanroom facility is customized for low- to medium-volume contract packaging projects.”
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ISO 13485-certified contract packaging services.
Source
“Medical device manufacturers rely on Packaging Compliance Labs for turnkey, ISO 13485–certified contract packaging services”
Buyer Snapshot
Best for
- Medical device manufacturers needing package validation and testing.
- Companies requiring specialized contract packaging for small to medium batches.
- Firms seeking to accelerate product launch timelines with compliant packaging solutions.
How engagement typically works
- Collaborative partnership throughout the packaging lifecycle.
- Turnkey solutions for contract packaging needs.
- Expert consultation for engineering and compliance challenges.
Typical deliverables
- Package validation reports.
- Shelf-life and transit testing results.
- Sterile barrier integrity testing.
- Contract packaged and labeled medical devices.
- CompliancePack™ (CPack) sterile packaging solutions.
Good to know
- Best when requiring ISO 11607 compliance for terminally sterilized medical devices.
- Best when needing services performed in an ISO 17025 accredited or ISO Class 7 cleanroom environment.
- Best when seeking to accelerate market readiness for new or existing medical devices.
Pricing
Model:
Custom pricing
HQ:
Boulder, US
Languages:
English
Timezones:
America/Denver
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
Additional packaging_shelf_life_testing Details
Packaging Tests Offered
Shelf-Life Testing, Sterile Barrier Package Integrity, Transit Testing, Material + Label
Standards Supported
ISO 11607, ISO 13485
Shelf Life Methods Offered
Accelerated aging, Real-time aging
Distribution Tests Offered
Transit Testing
Lead Time Band
Start in 2-4 weeks
Pricing Model
Per project
