FYI
如果真是针对于直接分装的无菌分针,如果没有较大的把握前面不产生金属的话(比如干燥后要进行粉碎,过筛),其实还是建议增加该装置(至少比口服制剂风险会高得多)
下面是EMA的Q&A,仅作参考:
1. Should metal detectors be used routinely in manufacturing processes for certain dosage forms e.g. tablet compression and encapsulation processes? H+V February 2015Metal could originate from raw materials as well as from equipment in manufacturing processes where metal parts could generate fragments due to the conditions of operation or damage to the equipment. It is recommended that metal detection is used for processes prone to this. In order to avoid routine use of metal detectors the company must demonstrate that it has identified and managed the risks such that the use of metal detectors for that particular process is not needed.
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