The MoldyNightmare: Questions and Answers, Part 1
霉菌的噩梦：问题和答案，第 1 部分
以下问答来自 PDA 药物微生物学会议的早餐会议“霉菌污染和修复——发霉的噩梦”。后发表在PDA电子期刊，The Moldy Nightmare: Questions and Answers, Part 1，作者真菌学家Ziva Abraham，在微生物和质量保证方面拥有超过35年的学术，研究，和工作经验。
Question
问题
If you see low-level recovery (1 or 2 CFU) on an airlock gowning bench every three months or so, with no other recoveries in the airlock, would you suspect inadequate cleaning practices?
如果每三个月左右在更衣间更衣长凳上检测到低水平霉菌（1 或 2 CFU），而更衣室中没有检测到其他微生物，你会怀疑是清洁措施不足吗？
Answer
回答
Low recovery in gowning areas is a common phenomenon, as this is the entry point into the controlled areas from the uncontrolled areas. Having said that, it is important to have a science-based cleaning program to address all mold that can be tracked through foot-borne traffic. The cleaning and disinfection program should include use of a general-purpose disinfectant with a surfactant that helps break surface tension and aids in cleaning as well as periodic use of a sporicidal agent to address bacterial and fungal spores.
更衣区域的低回收是一种普遍现象，因为这是从非受控制区域进入受控区域的入口。话虽如此，制定一个基于科学的清洁程序来解决可以通过人员带入的所有霉菌非常重要。清洁和消毒程序应包括使用带有表面活性剂的广谱消毒剂以帮助打破表面张力并有助于清洁，以及定期使用杀孢子剂来解决细菌和真菌芽孢。
Question
问题
If mold is found only in air sampling (not on surface), what should be the action plan?
如果仅在空气采样中发现霉菌（而不是在表面上），应该采取什么行动计划？
Answer
回答
Mold recovery in air samples may be due to multiple reasons. Surface contaminants can become airborne, so the source could be foot- or wheel-borne contamination brought in. Inadequate storage of monitoring equipment and inadequate wipe-down procedures can be another reason. Monitoring equipment without a HEPA-filtered exhaust is known to be a contamination source. Growth of mold in walls after leaks, compromised HEPA filters, or mold growing on seals can cause airborne mold recovery. It is also important to track the mold to its source and map the transport into the area where it was recovered. Often dead spaces (e.g., in cleanrooms where the air is not cleared due to the location of HEPA filters), returns, and cleanroom and barrier system integration may allow the contaminants to linger for a long time.
空气样品中的霉菌可能由多种原因造成。表面污染物可能会在空气中传播，因此可能来源于足底或轮子上的污染物。监测设备保存不当和擦拭程序不当可能是另一个原因。众所周知，排气没有HEPA过滤的监测设备是污染源。HEPA过滤器受损泄漏后墙壁上的霉菌生长，或密封件上的霉菌生长会导致空气中的霉菌。追踪霉菌的来源及其传播途径也很重要。通常，死区（例如，洁净室中局部区域由于HEPA过滤器的位置布局而空气未被清除），回风以及洁净室和屏障系统的集成可能会使污染物长时间徘徊。
If the mold is found in filling areas, especially RABs, the area between the HEPAs without a diffuser membrane is hard to clean and can hold contaminants that can become airborne.
如果在灌装区域（尤其是RAB）中发现霉菌，则没有散流板的HEPA之间的区域很难清洁，并且可能会容纳可能通过空气传播的污染物。
Finally, depending upon the mold species recovered, especially the deuteromycotous fungi, which proliferate very fast, an abiotic factor such as moisture, carbon source, mineral oil, etc., should be looked at.
最后，根据回收的霉菌种类，特别是增殖非常快的半知菌类真菌，应考虑水分，碳源，矿物油等非生物因素。
In summary, the investigation should be based on the genus recovered and the source, and the remedial action should be based on the above-mentioned points.
综上所述，调查应以所检测到的霉菌的属和来源为依据，补救措施应以上述几点为依据。
Once the source has been determined, increasing use of sporicidal agent, especially where the mold source is found, and trending monitoring data to assess the effectiveness of remedial measures is recommended. If a decision for using fogging is made, as the root cause is undetermined, the chemistry of the fog, the fog size, and the number of foggers to be used to cover the area in question should be considered. The smaller the fog particle size, the more buoyant, allowing it to stay in the air for longer periods of time.
一旦确定了霉菌来源，建议增加杀孢子剂的使用，特别是在发现霉菌源的情况下，并建议使用趋势监测数据来评估补救措施的有效性。如果决定使用雾化（消毒），由于根本原因尚未确定，应考虑（消毒剂）雾的化学性质、（消毒剂）雾的大小以及用于覆盖相关区域的雾化器数量。雾粒径越小，浮力越大，使其在空气中停留的时间更长。
Question
问题
What mold genus should be included in disinfection efficacy studies?
消毒功效研究中应包括哪些霉菌属？
Answer
回答
It is beneficial to use a USP-recommendedAspergillus strain along with the one or two predominant mold isolates recovered from the environment or product testing. Per the recent European standard, EN 13697, it is recommended to use the mature Aspergillus spores for disinfectant qualification.
使用USP推荐的曲霉菌菌株以及从环境或产品测试中回收的一种或两种主要霉菌分离株是有益的。根据最近的欧洲标准EN 13697，建议使用成熟的曲霉菌孢子进行消毒剂确认。
Question
问题
Why do some molds fail during disinfectant qualification studies?
为什么有些霉菌在消毒剂确认研究中会失效？
Answer
回答
Disinfectant label claim testing is performed using colorless deuteromycotous fungiAspergillus and Trichophyton. Disinfectants with fungicidal claims, while using this testing method, may not be able to kill some colored Deuteromycota, most Ascomycota, and some Zygomycota.
消毒剂标签声明测试是使用无色半知菌类霉菌曲霉菌和毛癣菌进行的。使用这种测试方法时，具有杀真菌声明的消毒剂可能无法杀死一些有色的半知菌类霉菌，大多数子囊菌和一些接合菌。
It is recommended to understand the structures of the mold recovered in the cleanroom against those tested for fungicidal label claim. In some cases, increasing the contact time may help with the required kill, while in other cases prevention is the best strategy.
建议了解在洁净室中回收的霉菌的结构，以对照那些测试的杀真菌标签声明。在某些情况下，增加接触时间可能有助于所需的杀灭，而在其他情况下，预防是最好的策略。
Question
问题
Is rotation of cleaning agent essential? Is it true that microbes grow resistant to the cleaning agent?
清洁剂的轮换是否必不可少？微生物对清洁剂产生耐受性是真的吗？
Answer
回答
There is no documented evidence of resistance, but to address all types of bacterial and mold contamination a rotation program utilizing a general-purpose disinfectant with surfactant, as well as a sporicidal agent, is effective at eliminating vegetative forms and spores.
没有书面的耐受性证据，但为了解决所有类型的细菌和霉菌污染，使用带有表面活性剂的广谱消毒剂以及杀孢子剂的轮换程序可有效消除繁殖体和芽孢。
Question
问题
Can you comment on the degree of disinfectant resistance between fungi and bacterial spores?
能评论一下真菌和细菌芽孢的消毒剂耐受性吗？
Answer
回答
Among the bacteria, the spore formers are harder to eliminate. For example,Bacillus cereus has the least kill even with sporicidal agents. It is hard for the disinfectant to penetrate the spore structure. As for ascomycotous mold, whose sexual spores are protected by two layers as compared to one layer in bacterial spores, it is harder to eliminate these fungi. Hence, preventing the entry of hard-to-kill bacterial spores and ascomycotous fungi that are soil or cellulous material-borne respectively is a winning strategy.
在细菌中，芽孢更难消除。例如，即使使用杀孢子剂，对蜡样芽孢杆菌的杀伤力也最低。消毒剂很难穿透芽孢结构。至于子囊菌霉菌，其有性芽孢受到两层保护，而细菌芽孢中有一层，因此更难消除这些真菌。因此，防止土壤或纤维材料携带的难以杀死的细菌芽孢和子囊菌真菌进入是一种成功的策略。
