Five common mistakes in sterile barrier packaging

Sterile barrier packaging fails in predictable ways. Five recurring mistakes:

1. Validating too late — ISO 11607-2 requires processes validated (IQ/OQ/PQ) before production.
2. Skipping accelerated aging — shelf-life claims need ASTM F1980 plus real-time confirmation.
3. Over-tight seals — a seal that won't peel cleanly risks fibre tear.
4. Ignoring sterilisation compatibility — material must match the method (EO, gamma, e-beam, steam).
5. Weak change control — any change can invalidate the sterile barrier.