目前没有强制要求,当然能除菌过滤肯定更好,但是相应成本人工也增加好多。目
前最新欧盟无菌附录有如下相关规定:
4.35 Disinfectants and detergents used in grade A and grade B areas should be sterile prior to use. Disinfectants used in grade C and D may also be required to be sterile where determined in the CCS. Where the disinfectants and detergents are diluted / prepared by the sterile product manufacturer, this should be done in a manner to prevent contamination and they should be monitored for microbial contamination. Dilutions should be kept in previously cleaned containers (and sterilized where applicable) and should only be stored for the defined period. If the disinfectants and detergents are supplied "ready-made" then results from certificates of analysis or conformance can be accepted subject to successful completion of the appropriate vendor qualification.
A级和B级区使用的消毒剂和清洁剂在使用前应无菌。如在CCS中确定,C级区和D级区使用的消毒剂也可能要求无菌。当消毒剂和清洁剂由无菌产品生产商稀释/制备时,应以防止污染的方式进行,并应监测微生物污染。稀释液应保存在预先清洁过(且灭菌过,如适用)的容器中,并且只能保存规定时长。如果消毒剂和清洁剂是“现成品”,则可以接受分析报告单或合格证的结果,但需要成功完成适当的供应商资质确认。