Packaging Validation

Medical device package validation is typically addressed separately from sterile barrier heat seal process validation. Want to save lots of money and time?

My preference is to perform a single comprehensive study that meets requirements for heat sealer process validation (per ISO 11607-2:2006) and packaging validation (per ISO 11607-1:2006). A single combined study can be more economical than performing separate studies. 

The combined study includes Installation Qualification (IQ), Operational Qualification (OQ) (high and low runs), and 3 Performance Qualification (PQ) runs. All test articles (dummy packages) are exposed to the worst-case routine sterilization process, climatic conditioning and distribution simulation (per ASTM D4169 for example), and accelerated and real time aging (per ASTM F1980). Actual working devices need not be enclosed in the packaging, but a dummy device that mimics the actual device should be used. This allows for relatively high sample sizes to be achieved without “wasting” valuable actual devices.

From my perspective, IQ is primarily entering the heat sealer into your calibration/maintenance program and testing alarm limits or any other special controls built into the equipment. Make sure you calibrate heat sealer time/temperature/pressure to bracket the settings (including tolerances) specified in your work instruction. I recommend selecting OQ high/low settings to account for measuring inaccuracy in addition to the work instruction tolerances. For example, if the temperature specification in the work instruction is 250+/-5 and the calibration accuracy tolerance is +/-2, I would use 243 for OQ lower limit and 257 for OQ upper limit.

The typical inspections/tests performed after sterilization, climatic conditioning, distribution simulation and aging (accelerated and real time) are:
– non-destructive visual seal inspection
– at least one whole-package integrity test (like bubble test per ASTM F2096, for example)
– seal peel strength (ASTM F88)
The same samples can be used for these tests, performed in the sequence shown.

If wisely designed, a single study of this type can be done ONE TIME in the device life-cycle, and the results can be directly applied to similar devices packaged in the same way. It’s validity can last for years if the package design and heat seal process parameters are not changed.

Published by Sam Lazzara

Sam Lazzara is a Biomedical Engineer (MS Case Western, BS Brown University) and Certified Biomedical Auditor with 30+ years medical device experience. Sam’s systems and documents have delighted dozens of regulatory auditors from the United States FDA, the California Department of Health, and a flock of European Notified Bodies. He has guided quality system implementation for over 20 firms, leading to third-party certification and government approvals. A medical device start-up specialist, Sam provides state-of-the-art solutions tailored to the needs of each client. He mentors clients on all aspects of quality assurance and regulatory affairs. Sam gets particularly excited about design control, risk management, and post-market surveillance.

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