Page 128 - Assurance of Sterility for Sensitive Combination Products and Materials

112 Assurance of sterility for sensitive combination products and materials

Example of a sterile packaging validation protocol outline
–Introduction
–Objectives
o Design validation, process validation, revalidation … indicate what is covered, indicate
key questions to be answered
–Product & process description
o Device description and requirements
o Packaging specification
o Packaging and Product Families
o Worst case consideration
o Process Workflow
o Transportation, distribution and storage environment
–References
–Regulatory requirements
–Test methods
o Rational for selection of test methods
o Acceptance criteria
o Sensitivity for integrity test methods
o Test equipment
o Validation of test methods
–Validation Resources
o Internal team and responsibilities
o Third party test labs support
–Study Design
o Process validation
IQ
OQ
PQ
Process control measures
o Sterilization
o Design validation
Stability testing
Performance testing
Clinical evaluation
–Data from previous studies
– Sampling and data handling Procedures
–Statistics
–Documentation and test report requirements
–Quality control and assurance
–Time line
– Attachments
Fig. 5.7 Example of a sterile packaging validation protocol outline.

Fig. 5.9 shows an alternative approach for a validation workflow as pro-
posed by the Sterile Barrier Association [90]. Interesting aspects of this ap-
proach is that it includes the creation of a baseline at time zero. This data can
be used as a reference to compare to accelerated aging and real-time aging
data. This is essential to draw final conclusions and for root cause analysis in
case of problems. Another interesting aspect is that product used for acceler-
ated aging and real-time aging has been exposed first to performance testing