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 a specialized provider of medical device packaging testing, contract packaging, and engineering services, dedicated to ensuring compliance and accelerating market entry 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 for low- to medium-volume projects.
* Packaging engineering support, assisting at any stage of the packaging process.
* Ensures compliance with ISO 11607 for validating terminally sterilized medical device packaging.
* Offers CompliancePack™ (CPack), an expedited sterile packaging solution designed to meet ISO 11607 requirements and accelerate launch timelines.
**Reputation / proof points**
* Operates a state-of-the-art facility accredited to ISO 17025 for all medical package testing.
* ISO Class 7 cleanroom facility for contract packaging.
* ISO 13485-certified contract packaging services.
* Offers 5,000 cubic feet of accelerated aging capacity.
Packaging Compliance Labs is a specialized provider of medical device packaging testing, contract packaging, and engineering services, dedicated to ensuring compliance and accelerating market entry 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 for low- to medium-volume projects.
* Packaging engineering support, assisting at any stage of the packaging process.
* Ensures compliance with ISO 11607 for validating terminally sterilized medical device packaging.
* Offers CompliancePack™ (CPack), an expedited sterile packaging solution designed to meet ISO 11607 requirements and accelerate launch timelines.
**Reputation / proof points**
* Operates a state-of-the-art facility accredited to ISO 17025 for all medical package testing.
* ISO Class 7 cleanroom facility for contract packaging.
* ISO 13485-certified contract packaging services.
* Offers 5,000 cubic feet of accelerated aging capacity.
Additional information
Packaging Compliance Labs provides a comprehensive approach to medical device packaging, from initial engineering and testing to final contract packaging. Their services are designed to streamline the path to market, particularly for small batch projects and sterile packaging needs. Clients can leverage their ISO 17025-accredited testing facility for validation, including transit, shelf-life, and sterile barrier integrity testing. The company emphasizes its role as a partner, offering support throughout the packaging lifecycle to ensure regulatory compliance and product readiness. Their CompliancePack™ solution is highlighted as a method to significantly reduce time-to-market for sterile packaged medical devices.
Key Highlights
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Operates an ISO 17025-accredited facility for medical package testing.
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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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.”
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Ensures compliance with ISO 11607 for medical device packaging.
Source
“We help ensure compliance with ISO 11607 for validating terminally sterilized medical device packaging.”
Certifications & Trust Signals
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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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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 ISO 11607 compliant packaging validation.
- Companies requiring specialized contract packaging in a cleanroom environment.
- Businesses seeking to accelerate product launches with expedited sterile packaging solutions.
How engagement typically works
- Collaborative partnership throughout the packaging process.
- End-to-end service from engineering to final packaging.
- Focus on risk reduction and market readiness.
Typical deliverables
- Package validation reports.
- Completed contract-packaged medical devices.
- Sterile barrier packaging solutions.
- Packaging engineering consultation.
Good to know
- Best when requiring ISO 17025 accredited testing.
- Best when needing ISO Class 7 cleanroom services for packaging.
- Best when aiming to leverage expedited sterile packaging solutions like CompliancePack™.
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
Standards Supported
ISO 11607, ISO 13485
Shelf Life Methods Offered
Real-time aging, Accelerated aging
Distribution Tests Offered
Transit Testing
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
