Material Analysis
3 Aufrufe
COC Insufficient Verification for Glass Replacement
Problembeschreibung
After COC replaced glass pharmaceutical packaging materials, customers reported transportation breakage or compatibility problems, the replacement project was forced to roll back, and the early investment was lost.
Ursachenanalyse
The performance differences between COC and glass (barrier property, surface characteristics, extractables) were insufficiently evaluated; the regulatory re-certification cycle is as long as 18~24 months; application condition verification coverage was incomplete.
Lösung
①Systematically compare barrier, extractables and compatibility data before replacement; ②complete biocompatibility and migration tests according to USP/ISO standards; ③reserve a sufficient verification period; ④trial in small batches before full switchover.
Wichtigste Erkenntnis
COC replacing glass is a dual verification project of regulation and performance; the 18~24 month re-certification cycle must be included in the project plan; data package completeness determines the success or failure of replacement.
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