The MoldyNightmare: Questions and Answers, Part 1
霉菌的噩夢(mèng)：?jiǎn)栴}和答案，第 1 部分
以下問(wèn)答來(lái)自 PDA 藥物微生物學(xué)會(huì)議的早餐會(huì)議“霉菌污染和修復(fù)——發(fā)霉的噩夢(mèng)”。后發(fā)表在PDA電子期刊，The Moldy Nightmare: Questions and Answers, Part 1，作者真菌學(xué)家Ziva Abraham，在微生物和質(zhì)量保證方面擁有超過(guò)35年的學(xué)術(shù)，研究，和工作經(jīng)驗(yàn)。
Question
問(wèn)題
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?
如果每三個(gè)月左右在更衣間更衣長(zhǎng)凳上檢測(cè)到低水平霉菌（1 或 2 CFU），而更衣室中沒(méi)有檢測(cè)到其他微生物，你會(huì)懷疑是清潔措施不足嗎？
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.
更衣區(qū)域的低回收是一種普遍現(xiàn)象，因?yàn)檫@是從非受控制區(qū)域進(jìn)入受控區(qū)域的入口。話雖如此，制定一個(gè)基于科學(xué)的清潔程序來(lái)解決可以通過(guò)人員帶入的所有霉菌非常重要。清潔和消毒程序應(yīng)包括使用帶有表面活性劑的廣譜消毒劑以幫助打破表面張力并有助于清潔，以及定期使用殺孢子劑來(lái)解決細(xì)菌和真菌芽孢。
Question
問(wèn)題
If mold is found only in air sampling (not on surface), what should be the action plan?
如果僅在空氣采樣中發(fā)現(xiàn)霉菌（而不是在表面上），應(yīng)該采取什么行動(dòng)計(jì)劃？
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.
空氣樣品中的霉菌可能由多種原因造成。表面污染物可能會(huì)在空氣中傳播，因此可能來(lái)源于足底或輪子上的污染物。監(jiān)測(cè)設(shè)備保存不當(dāng)和擦拭程序不當(dāng)可能是另一個(gè)原因。眾所周知，排氣沒(méi)有HEPA過(guò)濾的監(jiān)測(cè)設(shè)備是污染源。HEPA過(guò)濾器受損泄漏后墻壁上的霉菌生長(zhǎng)，或密封件上的霉菌生長(zhǎng)會(huì)導(dǎo)致空氣中的霉菌。追蹤霉菌的來(lái)源及其傳播途徑也很重要。通常，死區(qū)（例如，潔凈室中局部區(qū)域由于HEPA過(guò)濾器的位置布局而空氣未被清除），回風(fēng)以及潔凈室和屏障系統(tǒng)的集成可能會(huì)使污染物長(zhǎng)時(shí)間徘徊。
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.
如果在灌裝區(qū)域（尤其是RAB）中發(fā)現(xiàn)霉菌，則沒(méi)有散流板的HEPA之間的區(qū)域很難清潔，并且可能會(huì)容納可能通過(guò)空氣傳播的污染物。
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，根據(jù)回收的霉菌種類(lèi)，特別是增殖非常快的半知菌類(lèi)真菌，應(yīng)考慮水分，碳源，礦物油等非生物因素。
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.
綜上所述，調(diào)查應(yīng)以所檢測(cè)到的霉菌的屬和來(lái)源為依據(jù)，補(bǔ)救措施應(yīng)以上述幾點(diǎn)為依據(jù)。
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.
一旦確定了霉菌來(lái)源，建議增加殺孢子劑的使用，特別是在發(fā)現(xiàn)霉菌源的情況下，并建議使用趨勢(shì)監(jiān)測(cè)數(shù)據(jù)來(lái)評(píng)估補(bǔ)救措施的有效性。如果決定使用霧化（消毒），由于根本原因尚未確定，應(yīng)考慮（消毒劑）霧的化學(xué)性質(zhì)、（消毒劑）霧的大小以及用于覆蓋相關(guān)區(qū)域的霧化器數(shù)量。霧粒徑越小，浮力越大，使其在空氣中停留的時(shí)間更長(zhǎng)。
Question
問(wèn)題
What mold genus should be included in disinfection efficacy studies?
消毒功效研究中應(yīng)包括哪些霉菌屬？
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推薦的曲霉菌菌株以及從環(huán)境或產(chǎn)品測(cè)試中回收的一種或兩種主要霉菌分離株是有益的。根據(jù)最近的歐洲標(biāo)準(zhǔn)EN 13697，建議使用成熟的曲霉菌孢子進(jìn)行消毒劑確認(rèn)。
Question
問(wèn)題
Why do some molds fail during disinfectant qualification studies?
為什么有些霉菌在消毒劑確認(rèn)研究中會(huì)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.
消毒劑標(biāo)簽聲明測(cè)試是使用無(wú)色半知菌類(lèi)霉菌曲霉菌和毛癬菌進(jìn)行的。使用這種測(cè)試方法時(shí)，具有殺真菌聲明的消毒劑可能無(wú)法殺死一些有色的半知菌類(lèi)霉菌，大多數(shù)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.
建議了解在潔凈室中回收的霉菌的結(jié)構(gòu)，以對(duì)照那些測(cè)試的殺真菌標(biāo)簽聲明。在某些情況下，增加接觸時(shí)間可能有助于所需的殺滅，而在其他情況下，預(yù)防是最好的策略。
Question
問(wèn)題
Is rotation of cleaning agent essential? Is it true that microbes grow resistant to the cleaning agent?
清潔劑的輪換是否必不可少？微生物對(duì)清潔劑產(chǎn)生耐受性是真的嗎？
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.
沒(méi)有書(shū)面的耐受性證據(jù)，但為了解決所有類(lèi)型的細(xì)菌和霉菌污染，使用帶有表面活性劑的廣譜消毒劑以及殺孢子劑的輪換程序可有效消除繁殖體和芽孢。
Question
問(wèn)題
Can you comment on the degree of disinfectant resistance between fungi and bacterial spores?
能評(píng)論一下真菌和細(xì)菌芽孢的消毒劑耐受性嗎？
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.
在細(xì)菌中，芽孢更難消除。例如，即使使用殺孢子劑，對(duì)蠟樣芽孢桿菌的殺傷力也最低。消毒劑很難穿透芽孢結(jié)構(gòu)。至于子囊菌霉菌，其有性芽孢受到兩層保護(hù)，而細(xì)菌芽孢中有一層，因此更難消除這些真菌。因此，防止土壤或纖維材料攜帶的難以殺死的細(xì)菌芽孢和子囊菌真菌進(jìn)入是一種成功的策略。
