CCIT
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Container Closure Integrity Testing (CCIT)제약, 바이오/Method 2023. 5. 19. 14:48
FDA/EP 가이드라인 비교 Guidance Remark USP Elastomeric Closure for Injections Self-Sealing Capacity Procedure: Fill 10 suitable vials with water to the nominal volume. Fit the closures that are to be examined, and cap. Using a new hypodermic needle as described above for each closure, pierce each closure 10 times, piercing each time at a different site. Immerse the 10 vials in a solution of 0.1% (1 g p..