Can J-Pac sterilize our product?
J-pac Medical facilities
Medical device contract manufacturing facility
J-Pac Medical offers in-house EtO sterilization that is most useful for small-lot production or high-volume production of small footprint packages. We also manage outside sterilization service companies. Our services range from organizing sterilization validations, single-lot releases, and management of on-going sterilization release and re-validation schedules.
Are you able to perform additional testing required for product releases such as endotoxin or bioburden?
While J-Pac Medical does not perform the actual testing of the samples we do have a laboratory that is on our approved supplier list that performs any required test.
Does J-Pac Medical have capacity available for Eto Processing?
While it is true that capacity is severely challenged, J-Pac Medical has available Eto Capacity in its GS8X Sterilizer, and has the ability and space to add chambers as needed to meet customer needs.
Can J-Pac Medical provide sterilization for implantable products that include resorbable polymers?
Yes. In fact, the WIP exposure of these products is minimized with the sterilization occurring under one roof with assembly and packaging as compared to a production flow requiring shipping of product to and from an off-site sterilizer. Degradation of the resorbable polymer is minimized with J-Pac Medical’s integrated assembly, packaging and sterilization flow.
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