What package design services does J-Pac offer?

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J-Pac offers a turnkey ISO/FDA compliant medical device package design and validation process that can be integrated into your technical files.

  1. We start with documenting customer requirements for their medical device package, which includes usability issues and aseptic transfer requirements, as well as labeling preferences.
  2. Next, we document the packaging system requirements that consider storage and transportation conditions, cleanliness, bioburden, and expected environmental stresses and constraints. Sterility methods and material compatibility are also assessed at this time.
  3. Based on these inputs, we design both the medical device sterile barrier system that will prevent microbial contamination and the protective packaging that will protect both the product and the sterile barrier system during shipment.
  4. Next, we manufacture prototypes under worse-case manufacturing conditions and test the feasibility of these designs in our in-house lab to ensure a high probability they will pass simulated distribution testing.
  5. Once the customer approves the medical device packaging prototypes, we can test usability with our panel of surgical nurses to ensure we meet the requirements for usability.
  6. All of this medical device package design work will be conducted under an ISO 13485 quality system including requirements specifications, test protocols, validation plans, and test reports and these are provided to the customer for their technical files. We also manage all outside testing services.