ISO 13485 Contract Packaging

Packaging Compliance Medical (PCM) is PCL’s contract packaging service that helps medical device manufacturers overcome small batch challenges so they can quickly launch products to market.

Our state-of-the-art ISO Class 7 cleanroom facility was designed specifically for low to medium-volume contract packaging. PCM’s services include a pre-validated packaging platform, labeling, packaging, precision cleaning, sterilization validation, and sterile product management that fill a much-needed gap that benefits medical device manufacturers and patients alike with accelerated product launches.

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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.

Sterile Product Contract Packaging

All pouch and tray packaging and sealing services occur in our ISO certified Class 7 cleanroom.

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.

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