Package & process validation
Package Validation is coming under increasing regulatory scrutiny. ISO 11607 has been updated in 2014 and ISO 13485-20XX looks very likely to directly reference requirements for package validation of sterile products. Sabre Medical carries over 20 years of experience with blister and pouching solutions that can save you the time, cost and stress of finding that your first choices were not up to the required standards. We make validation straightforward.
Package validation must demonstrate that the seal prevents the ingress of microorganisms, under test conditions which consider:
- sterilization process,
- and storage
The validation plan must address all planned modes or configurations the package must go through before reaching the customer.
Sabre has proven experience in assessing your manufacturing needs, developing package validation plans, executing the plan in short timeframes, and providing a significant portion of your design dossier that simply requires your approval before inclusion.