Production & Quality
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PEI Medical Sterilization Discoloration
Problembeschreibung
PEI medical devices change color after multiple sterilizations; although color stability is relatively good, batch difference complaints still occur.
Ursachenanalyse
PEI can withstand more than 1000 steam sterilization cycles and maintains good color stability over hundreds of sterilization cycles; but differences in sterilization methods and over-limit parameters still have an impact; gamma, ethylene oxide, and vaporized hydrogen peroxide each have their own characteristics.
Lösung
①Verify color stability according to the sterilization method; ②execute sterilization parameters in a standardized manner; ③batch color sampling inspection; ④record and manage the number of sterilization cycles.; after adjustment, continuously sample to verify the effect, and resume mass production after confirming stability
Wichtigste Erkenntnis
The thousand-cycle-level sterilization tolerance of PEI medical parts is an advantage; method differences must be verified separately; cycle records support life management.; after confirming effectiveness, fix the parameters and practices into the work instruction to prevent recurrence
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