推荐回答（1个）
非最终灭菌产品的无菌保证水平怎么理解
在最终灭菌注射剂(如大输液等)的生产过程中， 配液、灌装可在非无菌环境中生产，而产品灌装后最 终需通过灭菌措施达到灭菌要求。比如，最终灭菌的 容量为5OⅡlL以上的大容量注射剂由于直接输入血 液，因此在其生产的全过程中应采取各种技术措施防 止微粒、微生物、内毒素污染，以保证人体用药安全。 在药液配制过程中，应根据具体产品的要求，设臵 0．22～O．45 Il m的微孔滤膜过滤器对药液进行过 滤，以降低药液中微生物、微粒的污染。大输液所用包 装容器，即玻璃瓶和胶塞应按规定进行清洗，包括粗 洗、精洗等。大输液的灭菌是在灌装后进行的，玻璃瓶 经灌装、扎盖后，由专用小车运至双扉式灭菌柜。灭菌 设施一般可用水浴式灭菌器， 以过热水为灭菌介质， 采用水喷淋方式对灌装后药品加热升温和灭菌，灭菌 后以循环水冷却。大输液的灭菌一般应按配液批号进 行安排，同一批号需要多个灭菌柜时，应编制亚批号。 1．2 非最终灭菌产品 采用非最终灭菌方式生产的无菌分装注射剂一 般是不耐热且不能进行成品灭菌的药品，所以必须特 别强调药品生产过程中的无菌操作。其生产作业区的 无菌操作与非无菌操作应严格分开，所有从非无菌操 作区进入无菌操作区的物料器具必须经过严格灭菌， 生产人员应按无菌作业要求进行人净程序。如在冻干 粉针剂的生产洁净室，原辅料需称量后被送入药液配 制(包括浓配、稀配)问按药品的要求配制好药液，药 液经过设在配液间内的2级或3级过滤，其中必须经 过过滤精度为0．22 u m的除菌过滤器后才能送入灌 装机被灌装入包装容器(如西林瓶等)。用于包装冻干 粉针的西林瓶须从进瓶间转入洗瓶灭菌间，先由纯水 和注射用水清洗后，经灭菌(一般采用干热灭菌法，隧 道灭菌装臵或灭菌柜)再送入灌装机用于灌装。而西 林瓶的瓶塞在洗塞间，经饮用水、纯水和注射用水清 洗后，采用蒸汽灭菌、硅化和干燥后待用。
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