USP 標準 – 藥劑師的 ISO/ASTM 參考
對於醫療和製藥產業,ZwickRoell 提供全面的產品組合,不僅在開發和生產方面,而且在醫療和製藥產品的包裝中,都考慮到法律框架和適用的標準及法規。
根據 ISO 和 ASTM 標準,在醫學和製藥領域的重要應用描述摘錄可以在我們醫療和製藥產業的綜合網頁中找到。
為了更好地引導藥劑師,他們參照的並非規範性標準,而是以 USP 標準為主,我們在下面提供了重要應用與美國藥典中相應 USP 章節的初步比較。我們致力於在現有基礎上擴充及更新這一點。
USP Chapter | Title | ISO Reference | Functional Proficiency Tests |
---|---|---|---|
1382> | Assessment Of Elastomeric Component Functional Suitability In Parenteral Product Packaging/Delivery Systems | ISO 7886-1 | Breakaway Force and Glide Force Test Leakage Test |
1382> | Assessment Of Elastomeric Component Functional Suitability In Parenteral Product Packaging/Delivery Systems | ISO 11040-4 | Glide Force Test Closure System Liquid Leakage Test Unscrewing Torque of the Tip Cap Pull-Off Force of the Tip Cap |
1382> | Assessment Of Elastomeric Component Functional Suitability In Parenteral Product Packaging/Delivery Systems | ISO 11040-6 | Glide Force Test Closure System Liquid Leakage Test Unscrewing Torque of the Tip Cap Pull-Off Force of the Tip Cap |
1382> | Assessment Of Elastomeric Component Functional Suitability In Parenteral Product Packaging/Delivery Systems | ISO 11040-8 | Breakaway Force and Glide Force Test Leakage Test Unscrewing Torque of the Tip Cap Pull-off Force of the Tip Cap Residual Seal Force (RSF) Test |
1382> | Assessment Of Elastomeric Component Functional Suitability In Parenteral Product Packaging/Delivery Systems | ISO 11608-3 | Glide Force Test Leakage Test |
1207> | Package Integrity Evaluation—Sterile Products | Residual Seal Force Test (RSF) | |
382> | Elastomeric Component Functional Suitability In Parenteral Product Packaging/Delivery Systems | ISO 7886-1 | Breakaway Force and Glide Force Test |
382> | Elastomeric Component Functional Suitability In Parenteral Product Packaging/Delivery Systems | ISO 11040-4 | Breakaway Force and Glide Force Test Pull-Off Force of the Tip Cap |
382> | Elastomeric Component Functional Suitability In Parenteral Product Packaging/Delivery Systems | ISO 11040-8 | Breakaway Force and Glide Force Test Pull-Off Force of the Tip Cap |
382> | Elastomeric Component Functional Suitability In Parenteral Product Packaging/Delivery Systems | ISO 11608-3 | Breakaway Force and Glide Force Test Leakage Test |