Packaging Compliance Medical (PCM) is an ISO 13485:2016 certified contract packager that specializes in pilot production and low to medium-volumes.
Program Details
CompliancePack™
CompliancePack™, or CPack, is PCM’s ISO 11607-compliant expedited packaging solution. PCM clients can save months on their device launch when they use Cpack for their sterile packaging. You can choose from either tray or pouch options.
Program Details
Who It's For
Clients of PCM
Timeframe
Typically 3 to 4 months
What's Included
Validations
All CPack pouches and trays are stocked at PCM, and have been validated to the following:
- Sealing Qualification (DOE, OQ), Accelerated Aging.
Next, your packaging will need to undergo product-specific testing:
- Transit Testing, Real-Time Aging, Performance Qualification (PQ).
CPack Tray
- Ideal for, but not limited to, small orthopedic devices.
- Includes a dual barrier system option, device containment, and shelf carton.
CPack Pouch
- General purpose use.
- Have PCL fit check your device in standard sizes.
- Customized pouch sizing is also available.
- Dual and single sterile barrier options.
Program Details
Sterile Product Contract Packaging
All pouch and tray packaging and sealing services occur in our ISO certified Class 7 cleanroom.
Program 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
Program Details
Sterilization Validation & Sterile Product Management
We help clients achieve sterilization validation and will manage that process for them. PCM partners with third party sterilization providers to ensure the correct sterilizing agent and the characterized exposure required to achieve sterility. PCM offers three methods: Gamma, EO, and EBeam.
Program Details
Who It's For
Clients of PCM
Timeframe
dependent on volumes and sterilization mode.
What's Included
- R&D Cycles
- Sterilization Validation
- Single Lot Release
- Routine Processing
- Quarterly Dose Audits