Production & Quality
2 views
PSU Failure Under High-temperature Sterilization
Problem Phenomenon
PSU medical devices show performance degradation and appearance changes after repeated high-temperature steam sterilization; failures accumulate with sterilization cycles.
Cause Analysis
Although PSU resists high-temperature steam, repeated sterilization still has cumulative effects; internal stress is released and deforms during thermal cycling; material grades differ in sterilization resistance levels; sterilization temperature and time exceeded limits.
Solution
①Select sterilization-resistant grades; ②Low-stress molding; ③Verify according to the number of sterilization cycles; ④Execute sterilization parameters per specifications.; After adjustment, continuously sample to verify the effect, and resume mass production only after confirming stability
Key Takeaway
The sterilization resistance of PSU medical parts requires cyclic verification; grade selection and process quality jointly determine life; parameter specification is a basic requirement.; After confirming effectiveness, solidify the parameters and practices into the work instructions to prevent recurrence
Was this helpful?
0 people found this helpful
Thank you for your feedback!