Program Details
Sterile Product Contract Packaging
Packaging Compliance Medical (PCM) is an ISO 13485-certified medical device contract packaging facility that specializes in low to medium volumes.
- PCM has no volume requirements.
- All pouch and tray packaging and sealing services occur in our ISO-certified Class 7 cleanroom.
- Medical device manufacturers can adopt into PCM’s pre-validated packaging, CompliancePack™, to help them speed to market.
Details
Who It's For
Clients of PCM
Timeframe
N/A
What's Included
- Kitting
- Light Assembly
- Pouch Sealing
- Tray Sealing
- Precision Cleaning (Parts Washing/Ultrasonic)
- Labeling
Pre-Validated Sterile Packaging
CompliancePack
CompliancePack™, CPack, is PCM’s pre-validated sterile packaging. You can shave months off your product launch when you use PCM as your sterile medical device contract packager and CPack for your sterile packaging.
How is this accomplished?
- First, we stock our CPack trays, pouches, and shelf cartons in-house.
- Second, some of the validations have been performed on the material.
Details
Who it's For
CPack prevalidated sterile packaging is available for contract packaging clients of PCM.
Testing Included:
- Sealing Qualification (DOE, OQ)
- Accelerated Aging (GAMMA, EO)
Product-Specific Testing Still Needed:
- Performance Qualification (PQ)
- Transit Validation
- Real-Time Aging