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從最新GMP指南看包裝完整性測試的4大方法

已有 558 次阅读2019-7-12 10:25

目前國家對藥品的質量要求越來越高，而檢漏要求也越來越高，尤其是針對無菌藥品的密封性測試，要求更爲嚴格，從最新的GMP政策很好地體現出來。GMP指南極大地提高了無菌藥品的生産及質量控制水平，制藥企業操作更爲嚴謹規範。在藥品包裝生産過程各個步驟都可能産生裂痕或裂縫，包裝完整性測試是藥品最終出廠的一個重要環節。主要包括檢測藥品包裝瓶有無裂縫，西林瓶膠塞與瓶口的密封效果以及安瓿瓶的熔封是否完好，有無大的漏孔等。

GMP指南提到的包裝完整性測試法主要包括：染色法，高壓放電法，微生物培養基侵入法。然而ASTM標准中還有另一種方法----真空衰減法，檢漏藥品包裝變得更加高效、快捷、簡便。真空衰減法可以替代染色法，微生物侵入法以及高壓放電法。相比這些檢測方式，真空衰減法擁有高效、靈敏、精度高等優勢。真空衰減法是無損檢漏，對包裝沒有破壞性，給企業節省了很大的成本。大多藥業檢漏用水浴染色法，但這種檢測方法是有破壞性的，相比真空衰減法更可靠，更靈敏，更精准。而高壓放電但它局限于測試導電的液體介質，而且溶液導電性要大于5μs/cm，真空衰減法則無這一局限性。微生物侵入的檢測方法實驗周期長，而買微生物培養的代價高，不利于産品批次檢測，且破壞性，而真空衰減法可以解決這一難題，並可最低檢測到1.5μm的漏孔。

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