Contract Manufacturing

Packaging Compliance Medical (PCM) is an ISO 13485:2016 certified contract packaging manufacturer (CM) that specializes in pilot production and low to medium volume contract manufacturing.

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

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

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

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