It is recommended to seal parts at OQmin (Operational Qualification minimum) because the seal strength is typically lower at this process limit, which can be critical in assessing the worst case scenario for seal integrity.
For products where loss of sterility is a high risk, it is generally recommended that Assurance Level I is selected. Products successfully tested to this level are known to provide very high performance with minimal transport damage and associated complaints.
Medical devices are shipped worldwide, so performance testing must take into account the intended shipping routes. ASTM 4169 – Distribution Cycle 13 simulates conditions applicable to the global distribution environment, including air freight (intercity) and...
Sample designs used to test packaging systems must be based on a statistically valid rationale. Typically, 59 samples are used for testing, but with proper risk analysis, sometimes 29 samples may be sufficient.
Packaging stability is tested by real time aging. Accelerated ageing data is considered sufficient evidence of the stated expiry date until real-time data is available.