Sterile medical device packaging process validation

When the development and validation of the packaging manufacturing process are completed, the standard testing procedures (e.g., ASTM) should be used to ensure sterile medical device package integrity and the sterility of the product after additional production processes. 

The FDA defines validation as establishing by objective evidence that the process, under anticipated conditions, including worst case conditions, consistently produces a product which meets all predetermined requirements (and specifications) Likewise, the ISO 11607 standard, Packaging for terminally sterilized medical devices, defines validation as a documented procedure for obtaining and interpreting the results required to establish that a process will consistently yield product complying with predetermined specifications. What these definitions are really saying in a practical sense is that a process validation must address ... 

ISO 11607 addr ses the package system validation in three phases, or clauses. Clause 4 specifies the basic attributes required for a wide range of materials as they combine and interact with various medical devices, packaging designs, sterilization methods, and distribution modes. Clause 5 defiites the framework of activities to qualify the processes used to make and assemble the final package... 

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