Pre-Validated Medical Packaging – BPACKSM
Some of the biggest hurdles to getting a new medical device on the market are the time and expense that it takes to design and validate a medical device packaging system. The ISO 11607 series specifies the requirements for designing and validating the manufacturing process for a packaging system to ensure that following a validated sterilization process, a medical device is sterile when placed on the market, and remains sterile under documented storage and transport conditions, until the sterile barrier system is opened by the end user.
As a contract packaging alternative, BPACKSM can reduce packaging development costs by over 30% and reduce development time by as much as 60%. (depending on the actual device and customer specifications)
BPACKSM is a line of stock medical device packaging systems created in standard sizes for both tray- and pouch-based systems. Biorep has pre-validated stock BPACKSM trays, lids and pouches, which cover a range of sizes. BPACKSM trays could also be customized within the seal flange of the stock trays to accommodate a wide range of devices and retention features that ensure the contents are protected.
To assist Biorep customers in getting new medical devices to the market quickly and cost-effectively, Biorep has developed the BPACKSM Pre-validated Medical Packaging family of products that can be adapted for a wide range of medical devices. Biorep has validated the sealing processes and a five-year shelf life for BPACKSM Pre-validated Medical Packaging per the requirements of ISO 11607, thereby saving Biorep customers months and thousands of dollars that would be spent in package design and validation work.
