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. Our CPack™ portfolio consists of a variety of sizes and shapes of flexible Tyvek peel pouches. We also offer Trays with Tyvek lids. Single-barrier and dual-barrier options are available.
Who is CompliancePack™ for?
PCL’s Contract Packaging Clients
What is Included?
Validations
The CPack™ portfolio of materials has been validated for use within PCL's ISO 13485-certified contract packaging business.
Choose from our available inventory of materials, shapes, and sizes
Choose secondary & protective packaging configuration, materials, and quantities (standard offerings available)
Adopt into up to 5 year sterile barrier shelf claim for both ETO or Gamma, as demonstrated in our ASTM F1980 accelerated aging study
Some packaging validation work, such as Process Qualification (PQ), transit testing, and real-time aging is application-specific and must be performed uniquely for your product-packaging system, so these validation activities are still required. We help you navigate these activities according to our standardized onboarding program in a seamless experience.
Options
01 CPack Tray
Ideal for, but not limited to, small orthopedic devices
Includes a dual barrier system option, device containment, and shelf carton
02 CPack Pouch
General purpose use
Have PCL fit check your device in standard sizes
Customized pouch sizing is also available.
Customized pouch sizing is also available.
