按照中国GMP第四章的要求，对于青霉素类药品需要专用厂房，同时应对排至室外的废气进行净化处理，高效过滤器对于青霉素颗粒具有过滤作用，是否能够完全过滤需要进行相关的检测和验证，由于青霉素的高致敏性以及人群的特殊性，青霉素的残留限度应该为现有检测手段下检测不到，这一点在FDA β-内酰胺药物交叉污染控制指南里有明确的规定(Guidance for Industry Non-Penicillin Beta-Lactam Drugs: A CGMP Framework for Preventing Cross-Contamination)，因此合适的检测方法至关重要，FDA在现行指南中推荐的方法为抗生素沉降碟方法（1977年，），通过这几年的FDA警告信分析，FDA目前推荐的检测方法是LC-MS（LOD 0.2ppb），在最新的 β-内酰胺药物交叉污染控制指南（2022.6草案）中对于此方法进行了索引，建议企业对于该方法进行开发和检验。
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中国GMP 第四章 厂房与设施 第二节 生产区
第四十六条 为降低污染和交叉污染的风险，厂房、生产设施和设备应当根据所生产药品的特性、工艺流程及相应洁净度级别要求合理设计、布局和使用，并符合下列要求：
（一）应当综合考虑药品的特性、工艺和预定用途等因素，确定厂房、生产设施和设备多产品共用的可行性，并有相应评估报告；
（二）生产特殊性质的药品，如高致敏性药品（如青霉素类）或生物制品（如卡介苗或其他用活性微生物制备而成的药品），必须采用专用和独立的厂房、生产设施和设备。 青霉素类药品产尘量大的操作区域应当保持相对负压，排至室外的废气应当经过净化处理并符合要求，排风口应当远离其他空气净化系统的进风口；
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Non-Penicillin Beta-Lactam Drugs: A CGMP Framework for Preventing Cross-Contamination Guidance for Industry1
非青霉素 β-内酰胺类药物：用于预防交叉污染的 cGMP 框架
Additionally, § 211.176 requires manufacturers to test non-penicillin drug products for penicillin where the possibility of exposure to cross-contamination exists, and prohibits manufacturers from marketing such products if detectable levels of penicillin are found.3
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FDA警告信实例：Deva Holding AS - Cerkezkoy Subesi 2019 Warning Letter 320-19-33
2. Your firm failed to test non-penicillin drug products for the presence of penicillin when a reasonable possibility existed that the non-penicillin drug product had been exposed to cross-contamination with penicillin (21 CFR 211.176).
You did not test your non-penicillin drug product, (b)(4) capsules, for the presence of penicillin despite the known possibility of cross-contamination with penicillin.
In response to the findings of the inspection, you stated in your March 6, 2019 response that retain samples from all batches of (b)(4) capsules distributed to the U.S. market were tested for penicillin contamination using a newly-validated analytical method, and all batches reported a result of “not detected”. However, your method for detecting penicillin in non-penicillin drugs manufactured at your facility is not sufficiently sensitive to detect very low levels of contamination. The limit of detection (LOD) for your method was reported to be (b)(4) mg/mL which is equivalent to (b)(4) parts per billion (ppb). (b)(4) ppb is not an acceptable LOD. Please see FDA’s published analytical method which has a LOD of 0.2 ppb at url.
In response to this letter, provide a commitment to either validate and implement FDA’s analytical method for the analysis of penicillin in non-penicillin drug products to achieve a LOD of 0.2 ppb or validate an analytical method with a LOD that is equivalent or better than 0.2 ppb.
http://lib.shilinx.com/wiki/index.php?title=FDA_WL_Deva_Holding_AS_Cerkezkoy_Subesi_20190806
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为帮助审核人员更快处理，请填写举报原因：
为帮助审核人员更快处理，请填写举报原因：
你是想问空气过滤器，还是说过滤压缩空气之类的气体过滤器。前者，没有什么除菌的说法，后者有，但是无论是哪个，都会对青霉素这类颗粒物有过滤作用。但是空气过滤器，需要看你是用哪个级别的，也需要做相应的验证，证明经过过滤的空气，是能够满足要求的。