近日，PDA在PDA-letter上發表了關于 如何洗手/手消，及如何穿戴無菌手套 的文章——《控制手部污染的最佳方法是什么？》，并給出潔凈室洗手、手消和穿戴無菌手套的詳細操作的建議，如下：

 

洗手（在制藥設施內的任何地方或進入更衣室時）：

 

用溫水（85 - 100 華氏度或 29 - 38 攝氏度）沖洗雙手 4 - 5 秒。

用洗手液和溫水洗手 20 秒，清洗雙手的所有表面，包括手心、手背和手指間。

用溫水沖洗雙手，直到手上看不到肥皂。

用潔凈室專用的熱風干手器或低顆粒無菌擦拭巾擦干雙手。

向雙手噴灑 4 - 5 毫升異丙醇，保持濕潤一分鐘，然后讓雙手自然風干。

 

無菌手套消毒：

 

用異丙醇充分噴灑無菌手套的外包裝，保持濕潤接觸時間一分鐘。

戴上第一雙無菌手套（顏色較深）。

噴灑異丙醇使手套濕透，然后讓其自然風干。

穿上無菌操作所需的無菌潔凈服。

再次噴灑異丙醇使手套濕透，然后讓其自然風干。

戴上第二雙無菌手套（顏色較淺）。

噴灑異丙醇使手套濕透，然后讓其自然風干。

進入潔凈室環境并開始工作。僅在接觸非無菌表面或部件容器后對雙手進行消毒（2 - 3 次）。

每 15 - 30 分鐘或在劇烈操作后檢查手套是否有穿孔，并根據需要進行更換。

 

翻譯如下：

 

What is the Best Way to Control Contamination on the Hands?

控制手部污染的最佳方法是什么？

 

PDA staff author David Jaworski, MBA

PDA 員工作者大衛?賈沃斯基，MBA

 

Handwashing has been an essential part of good hygiene practices for manufacturing drug products for over a century.

一個多世紀以來，洗手一直是藥品生產良好衛生規范的重要組成部分。

 

At present, there are many methods that are used by sterile drug manufacturing employees to clean and sanitize their hands before gowning and while wearing sterile gloves. Handwashing has evolved from simply washing hands with hot water to complex processes such as washing hands and forearms up to elbows for at least 30 seconds, cleaning under fingernails and drying with low-lint disposable towels or wipes. The use of 70% isopropyl alcohol (IPA) has also become a practice that is used in lieu of handwashing, which ranges from simple spritzes of alcohol on the hands to total soaking of hands with IPA, wiping off the hands with a sterile wipe and applying IPA a second time then allowing hands to air dry.

目前，無菌藥品生產人員在穿戴潔凈服前和佩戴無菌手套時，有很多方法來清潔和消毒雙手。洗手方式已從簡單的用溫水洗手演變為復雜的流程，比如洗手并洗至肘部的前臂至少 30 秒、清潔指甲下方，并用低絨一次性毛巾或濕巾擦干。使用 70% 異丙醇（IPA）也已成為一種替代洗手的做法，從簡單地在手上噴灑酒精，到將手完全浸泡在異丙醇中，用無菌濕巾擦干手，然后再使用異丙醇，然后讓手自然風干。

 

Over the last 30 years, aseptic personnel have gradually become a standard practice to apply IPA frequently to their outer (second pair) sterile gloves as they perform their aseptic work. During the COVID-19 pandemic, there were significant arguments over whether it was better to use soap and water or IPA to wash and sanitize hands to prevent virus transmission. The evidence relied on during the arguments supported one or the other position, with no one practice providing 100% reliability. The same situation is found in aseptic manufacturing. This article will review the evidence and provide recommendations on the best processes to use for cleaning and sanitizing hands before gowning and the need for frequent application of sterile IPA to sterile gloves.

在過去 30 年里，無菌操作人員在進行無菌工作時，對外層（第二雙）無菌手套頻繁使用異丙醇已逐漸成為一種標準做法。在疫情期間，關于用肥皂和水還是異丙醇洗手消毒以預防病毒傳播哪種方式更好存在很大爭議。爭論中所依據的證據支持不同立場，沒有一種做法能提供 100% 的可靠性。無菌生產中也存在同樣的情況。本文將回顧相關證據，并就穿戴潔凈服前清潔和消毒雙手的最佳流程，以及是否需要經常往無菌手套上使用無菌異丙醇給出建議。

 

A Review of the Available Literature

現有文獻綜述

 

After researching the literature (115 studies and references), it became evident that many of the studies performed on handwashing and alcohol use to sanitize hands were not standardized and could not be used to determine the true effectiveness of either method. Many of the studies were performed in healthcare settings and studies in pharmaceutical aseptic cleanrooms were rare. Only four published studies examined handwashing within an aseptic cleanroom operation, and two of those studies were in a compounding operation.

在研究了相關文獻（115 項研究和參考文獻）后發現，許多關于洗手和使用酒精消毒雙手的研究并不規范，無法用于確定這兩種方法的真正有效性。許多研究是在醫療環境中進行的，而在制藥無菌潔凈室中的研究很少。只有四項已發表的研究考察了無菌潔凈室操作中的洗手情況，其中兩項研究是在配制操作中進行的。

 

In 2010, Keen et al. did a controlled study to determine if glove and surgical instrument disinfection after mouse surgeries using a thirty-second contact time with 70% IPA would allow the same gloves and instruments to be used repeatedly without sterilization. The study found that the IPA sanitization of the gloves and instruments prevented bacterial contamination of the gloves for up to five mouse surgeries, and only two samples from surgical instruments were contaminated using the same instruments during the study. The gloves post-surgical sampling before disinfection found elevated levels of microbial contaminants on the gloves prior to sanitization with the IPA.

2010 年，基恩等人進行了一項對照研究，以確定在小鼠手術后用 70% 異丙醇接觸 30 秒對手術手套和器械進行消毒，是否能使相同的手套和器械在不進行滅菌的情況下重復使用。研究發現，用異丙醇對手套和器械進行消毒，可使手套在多達五次小鼠手術中免受細菌污染，并且在研究過程中使用相同器械時，只有兩個手術器械樣本受到污染。在消毒前對手套進行術后采樣發現，在使用異丙醇消毒前，手套上的微生物污染物水平有所升高。

 

Across all control and experimental groups, no bacterial growth was found on autoclaved instruments and sterile surgical gloves prior to each procedure.

在所有對照組和實驗組中，每次手術前對高壓滅菌器械和無菌手術手套進行檢測，均未發現細菌生長。

 

Clinical adverse events caused by viral contamination of hospital equipment led Ribeiro et, al. to study surface disinfection of equipment surfaces with 70% IPA. Although this study did not look specifically at hand or glove sanitization, it did provide information that could be considered important when preparing procedures for hand and glove sanitization. This study found that after materials were disinfected with IPA rubbed on surfaces for 10 seconds, microorganisms were detected in 104/282 (36.9%) effectiveness tests and in 23/92 (25.0%) efficacy tests that were conducted. Field studies found that disinfection was not achieved for 74/218 (33.9%) of the products that were submitted to previous cleaning. In controlled laboratory studies, IPA disinfection was not efficacious in 11/30 (36.7%) and non-sterile 12/62 (19.4%) products, respectively.

醫院設備受病毒污染導致的臨床不良事件促使里貝羅等人研究用 70% 異丙醇對設備表面進行消毒。雖然這項研究沒有專門關注手部或手套的消毒，但它確實提供了一些在制定手部和手套消毒程序時可被認為重要的信息。該研究發現，用異丙醇在材料表面擦拭 10 秒進行消毒后，在進行的 282 次有效性測試中有 104 次（36.9%）檢測到微生物，在 92 次功效測試中有 23 次（25.0%）檢測到微生物。現場研究發現，在之前清潔過的 218 種產品中，有 74 種（33.9%）未達到消毒效果。在對照實驗室研究中，異丙醇消毒對 30 種產品中的 11 種（36.7%）和 62 種非無菌產品中的 12 種（19.4%）無效。

 

The experiment found that the IPA 10-second rubbing was effective at eliminating herpes simplex virus, but type 5 adenovirus was found on the samples. Adenoviruses are a group of DNA viruses that easily infect humans and are responsible for the common cold and other viral infections. A type 8 adenovirus caused an epidemic keratoconjunctivitis outbreak in patients exposed to a pneumotonometer despite the fact it was cleaned with 70% isopropyl alcohol.

實驗發現，用異丙醇擦拭 10 秒可有效消除單純皰疹病毒，但在樣本中發現了 5 型腺病毒。腺病毒是一組容易感染人類的 DNA 病毒，可引起普通感冒和其他病毒感染。一種 8 型腺病毒在接觸眼壓計的患者中引發了流行性角結膜炎爆發，盡管眼壓計用 70% 異丙醇進行了清潔。

 

This study concluded that procedures using a 10-second rub with IPA are not safe for disinfection of microbial contamination found on semi-critical instruments. Different disinfection methods should be based on the microorganism bioburden, organic and inorganic residues, and the type of instruments being disinfected. This is cautionary evidence that a 10-second rub with IPA on gloves may not effectively disinfect the gloves used in cleanrooms, depending upon the dirt load.

該研究得出結論，用異丙醇擦拭 10 秒的程序對于消毒半關鍵器械上的微生物污染并不安全。不同的消毒方法應根據微生物負荷、有機和無機殘留物以及被消毒器械的類型來選擇。這警示我們，根據污垢負荷情況，用異丙醇在手套上擦拭 10 秒可能無法有效對手套進行消毒。

 

A 2023 study on the efficacy of various handwashing methods against enveloped and non-enveloped viruses by Anderson et al. relied upon very controlled test procedures using RT-qPCR and is one of the best studies found on handwashing. The study found that several alternative handwashing methods, but not all, were as effective in a laboratory setting for the removal and inactivation of viral surrogates as washing with soap and water for 20 seconds. Washing with soapy water and water alone for 20 seconds had testing data similar to washing with soap and water for 20 seconds. Additionally, the study found that IPA disinfection of hands was effective for enveloped viruses but not for non-enveloped viruses, which was expected based on previous laboratory studies. The test results found that handwashing using towel methods did not remove the viral surrogates used.

2023 年，安德森等人進行了一項關于各種洗手方法對包膜病毒和非包膜病毒效果的研究，該研究采用了嚴格控制的逆轉錄定量聚合酶鏈式反應（RT-qPCR）測試程序，是已發現的關于洗手的最佳研究之一。研究發現，在實驗室環境中，幾種替代洗手方法（但并非全部）在去除和滅活病毒替代物方面與用肥皂和水洗手 20 秒的效果相同。用肥皂水和單獨用水洗手 20 秒的測試數據與用肥皂和水洗手 20 秒相似。此外，研究發現用異丙醇對手進行消毒對包膜病毒有效，但對非包膜病毒無效，這與之前的實驗室研究預期相符。測試結果還發現，用毛巾洗手的方法無法去除所用的病毒替代物。

 

An interesting study conducted using nurses in a hospital setting conducted by Aman Nation et al. found there was no significant difference between using a 0.175% chloroxylenol/0.3% salicylic acid soap handwashing method compared to a 70% ethyl alcohol rub in reducing the bioburden on hands. The average of total colonies decreased by 59.5% using the handwashing method and by 47.2% using the 70% ethyl alcohol rub.

阿曼?納森等人在醫院對護士進行的一項有趣研究發現，使用 0.175% 對氯間二甲苯酚 / 0.3% 水楊酸肥皂洗手與用 70% 乙醇擦手在減少手部生物負荷方面沒有顯著差異。使用洗手方法時，總菌落數平均減少 59.5%，使用 70% 乙醇擦手時減少 47.2%。

 

Baseline testing of the nurses found Staphylococcus epidermidis in 10 samples (47.62%), coagulase-negative staphylococci (CoNS) in 6 samples (28.75%), Bacillus subtilis in 2 samples (9.52%), Klebsiella oxytoca in 2 samples (9.52%) and 1 sample containing Escherichia coli (4.76%). After using the 70% ethyl alcohol hand rub, test samples did not find Klebsiella oxytoca and E. coli. Still, they did find Staphylococcus epidermidis on ten samples (55.55%), CoNS in six samples (33.33%) and Bacillus subtilis in two samples (11.12%). The findings support the requirement that sterile gloves be worn during aseptic operations even though bioburden is reduced by hand washing or alcohol rubs because the hands are not sterile after washing.

對護士進行的基線檢測發現，10 個樣本（47.62%）中有表皮葡萄球菌，6 個樣本（28.75%）中有凝固酶陰性葡萄球菌（CoNS），2 個樣本（9.52%）中有枯草芽孢桿菌，2 個樣本（9.52%）中有產酸克雷伯菌，1 個樣本（4.76%）中含有大腸桿菌。使用 70% 乙醇擦手后，測試樣本中未發現產酸克雷伯菌和大腸桿菌，但仍在 10 個樣本（55.55%）中發現了表皮葡萄球菌，6 個樣本（33.33%）中發現了凝固酶陰性葡萄球菌，2 個樣本（11.12%）中發現了枯草芽孢桿菌。這些發現支持了在無菌操作中佩戴無菌手套的要求，因為即使洗手或用酒精擦手可降低生物負荷，但洗手后雙手并非無菌狀態。

 

The U.S. Food and Drug Association’s (FDA) Produce Safety Rule provides general guidelines like those found in a pharmaceutical hygiene program. A study conducted using farmworkers demonstrated the need for an effective handwashing procedure to reduce microbial contamination. Although the study conducted by Prince-Guerra et al. examined highly soiled hands, the procedures evaluated provide a good basis for application within the pharmaceutical industry.

美國食品藥品監督管理局（FDA）的《農產品安全規則》提供了與制藥衛生計劃類似的通用指南。一項針對農場工人的研究表明，需要有效的洗手程序來減少微生物污染。雖然普林斯 - 格拉等人進行的研究考察的是污染嚴重的手，但所評估的程序為在制藥行業中的應用提供了良好的基礎。

 

The concentrations of soil and some bacterial indicators on hands significantly differed across produce commodities that the farm workers were harvesting. Without hand hygiene, bacterial concentrations of 0.88 – 5.1 log10 CFU/hand) were observed and there was a moderate correlation (ρ = −0.41 – 0.56) between soil load and bacterial concentrations. Data in the study found that a two-step IPA intervention was comparable to handwashing with soap and water in reducing bacteria on farmworker hands, but handwashing does not always reduce bioburden on the hands.

農場工人在收獲不同農產品時，手上的污垢濃度和一些細菌指標存在顯著差異。在不進行手部衛生清潔的情況下，觀察到細菌濃度為 0.88 - 5.1 log10 CFU / 手，并且污垢負荷與細菌濃度之間存在中等相關性（ρ = -0.41 - 0.56）。研究數據發現，在減少農場工人手上的細菌方面，兩步式異丙醇干預與用肥皂和水洗手的效果相當，但洗手并不總是能降低手上的生物負荷。

 

The farm workers performed handwashing by rinsing hands under potable water, rubbing 2 ml of non-antimicrobial hand soap onto the hands for ∼15 – 20 seconds, rinsing again with potable water and then drying the hands with a single-use paper towel.

農場工人洗手的方式是在飲用水下沖洗雙手，將 2 毫升非抗菌洗手液涂抹在手上揉搓約 15 - 20 秒，再用飲用水沖洗，然后用一次性紙巾擦干雙手。

 

The two-step IPA rub process starts by applying 3 – 4.5 ml (two to three dispenser pumps) of IPA to the hands. After rubbing the hands for ∼15 – 20 seconds, excess IPA is wiped off with a single-use paper towel. Lastly, an additional pump of IPA is dispensed, and the worker’s hands are rubbed together until dry.

兩步式異丙醇擦拭過程是先將 3 - 4.5 毫升（兩到三泵）異丙醇涂抹在手上。揉搓雙手約 15 - 20 秒后，用一次性紙巾擦掉多余的異丙醇。最后，再擠出一泵異丙醇，工人雙手揉搓直至干燥。

 

The results were that handwashing exhibited ∼1.4 log10 reduction and the two-step IPA procedure exhibited ∼ 0.4 log10 reduction in hand microbial bioburden compared with the control groups.

結果顯示，與對照組相比，洗手可使手部微生物生物負荷降低約 1.4 log10，兩步式異丙醇程序可使手部微生物生物負荷降低約 0.4 log10。

 

The U.S. Food and Drug Administration's (FDA) Food Safety Modernization Act, Final Rule on Produce Safety requires that personnel wash their hands with soap and water but the FDA’s Produce Safety Rule clearly states that “you may not use antiseptic hand rubs as a substitute for soap (or other effective surfactant) and water” because they are ineffective at removing bacteria when dirt, grease and oil are present on people's hands. Prince-Guerra et al. hypothesized that the amount and types of soil and microbes present on farmworker hands prior to handwashing might influence the efficacy of different hand hygiene methods at reducing microbial contamination, and he recommend that the FDA Final Rule on Produce Safety should allow the use of a two-step IPA hand sanitization procedure in places where handwashing with soap and water is not available.

美國食品藥品監督管理局（FDA）的《食品安全現代化法案》中關于農產品安全的最終規定要求人員用肥皂和水洗手，但 FDA 的《農產品安全規則》明確指出，“不得使用抗菌擦手液替代肥皂（或其他有效表面活性劑）和水”，因為當人們手上有污垢、油脂時，抗菌擦手液無法有效去除細菌。普林斯 - 格拉等人假設，農場工人洗手前手上的污垢和微生物的數量及類型可能會影響不同手部衛生方法減少微生物污染的效果，他建議 FDA 關于農產品安全的最終規定應允許在無法用肥皂和水洗手的地方使用兩步式異丙醇手部消毒程序。

 

The Prince-Guerra article demonstrates the need for science-based flexibility when designing hygiene programs for pharmaceutical use.

普林斯 - 格拉的文章表明，在設計制藥用衛生計劃時需要基于科學的靈活性。

 

It is known that people do not consistently wash their hands. An observational video and soil removal study by Chen Shi et al. highlighted the variability found when a total of 744 videos of 664 subjects were reviewed and graded on the observed practices.

眾所周知，人們洗手的情況并不一致。陳石等人進行的一項觀察視頻和污垢去除研究強調了在對 664 名受試者的 744 個視頻進行觀察并根據觀察到的行為進行評分時發現的差異。

 

Individual hand - washing effectiveness was quantified by the percentage of residual fluorescent gel on each subject's hands' back and palm areas.

個人洗手效果通過每個受試者手背和手掌區域殘留熒光凝膠的百分比來量化。

 

Rubbing between fingers was the most frequently omitted step, and rubbing the back of fingers was the most frequently performed incorrectly. After considering all variables associated with washing hands, rubbing hands during rinsing and rinsing time were significantly associated with hand washing effectiveness. The optimal overall hand washing time was 31 seconds, with each step ideally lasting 4 – 5 seconds, except for rubbing between fingers. The palms of both hands had fewer fluorescent residuals than the back of the hands. The areas where residuals appeared were wrists, followed by fingertips, finger webs and thumbs.

手指間揉搓是最常被遺漏的步驟，而揉搓手指背是最常做錯的步驟。在考慮了與洗手相關的所有變量后，沖洗時揉搓雙手和沖洗時間與洗手效果顯著相關。最佳的整體洗手時間是 31 秒，除了手指間揉搓外，每個步驟理想情況下持續 4 - 5 秒。雙手掌心的熒光殘留比手背少。出現殘留的區域依次是手腕、指尖、指縫和拇指。

 

This study reinforced the need for effective personnel training to perform hand washing in a consistent step - by - step process that emphasizes no shortcuts are allowed. Trainers can use fluorescent gel applied to the hands before washing as a valuable tool when training pharmaceutical personnel.

這項研究強調了進行有效人員培訓的必要性，以便按照一致的逐步流程洗手，強調不允許走捷徑。培訓人員在培訓制藥人員時，可以將洗手前涂抹在手上的熒光凝膠作為一種有價值的工具。

 

A meta - analysis conducted by Ian Ross, PhD, on the effectiveness of handwashing with soap to prevent acute respiratory infections supports previously discussed study results that show reduced incidence of infection after interventional handwashing is instituted in health care settings of low - and middle - income countries (1).

伊恩?羅斯博士進行的一項關于用肥皂洗手預防急性呼吸道感染有效性的薈萃分析支持了前面討論的研究結果，即在低收入和中等收入國家的醫療環境中實施干預性洗手后，感染發生率有所降低（1）。

 

One contrarian study, A Comparison of the Bacterial Contamination of the Surface of Cleanroom Operators’ Garments Following Donning with and Without Gloves, by Laurie M. Smith et, al. found significant contamination of cleanroom garments after donning. This study only had 27 operator gowning events that were sampled with and without wearing gloves. It was astonishing to find that contamination was observed in the middle of the back of the garments after donning. However, there was little information on the training used for the operators, their qualification results or observed gowning practices. Additionally, the use of IPA was not discussed to decontaminate the packages holding the garments, the bench in the cleanroom or the gloves after each step of the donning process. This article further proposes that there was no difference in the levels of bacterial contamination on operator garments between bare hands, non - sterile gloves or sterile cleanroom gloves. Given the deficiencies noted above, this study should be repeated using larger populations and following current pharmaceutical aseptic gowning practices.

勞里?M?史密斯等人進行的一項有爭議的研究《戴手套和不戴手套后潔凈室操作人員服裝表面細菌污染的比較》發現，穿戴潔凈室服裝后有明顯的污染。這項研究僅對 27 次操作人員穿戴服裝的事件進行了采樣，包括戴手套和不戴手套的情況。令人驚訝的是，在穿戴后，在服裝背部中間觀察到了污染。然而，關于操作人員所接受的培訓、他們的資質結果或觀察到的穿戴操作規范的信息很少。此外，在穿戴過程的每一步之后，對于使用異丙醇對裝衣服的包裝、潔凈室的工作臺或手套進行消毒的問題也沒有討論。這篇文章還提出，裸手、非無菌手套或無菌潔凈室手套對操作人員服裝的細菌污染水平沒有差異。鑒于上述缺陷，這項研究應該使用更大的樣本量并遵循當前制藥無菌穿戴規范重新進行。

 

When it comes to wearing sterile gloves, there are a few myths that have been studied by the surgery centers. Denise Korniewicz and Maher El - Masri explored the benefits of double gloving during surgery and the human factors associated with cleanroom glove use. They conducted a 24 - month study and found that sterile gloves develop micro - perforations over time as they are worn. The process of wearing two gloves needs to be carefully designed with attention paid to the type and make of sterile gloves purchased to maintain dexterity and ease of donning. The study also found that wearing different colored gloves in a double - gloving practice allows for earlier detection of perforations and timely glove replacement, thereby reducing the risk of contamination.

在佩戴無菌手套方面，手術中心對一些常見的誤解進行了研究。丹妮絲?科爾涅維奇和馬赫?埃爾 - 馬斯里探討了手術中戴雙層手套的好處以及潔凈室手套使用中的人為因素。他們進行了一項為期 24 個月的研究，發現無菌手套在佩戴過程中會隨著時間推移出現微小穿孔。戴兩層手套的過程需要精心設計，要注意所購買無菌手套的類型和品牌，以保持靈活性和穿戴便利性。該研究還發現，在戴雙層手套時使用不同顏色的手套可以更早發現穿孔并及時更換手套，從而降低污染風險。

 

Tim Sandle, PhD, proposed a schema for glove disinfection in 2023 that set an effective baseline for the use of gloves in aseptic operations (2). In his article, the importance of each element of glove selection, donning process design, glove disinfection, handling of cleanroom items and assessment of practices was discussed along with data related to sterile glove handling. As stated earlier, this article also mainly references studies conducted in healthcare settings with only a few that address pharmaceutical aseptic practices.

蒂姆?桑德爾博士在 2023 年提出了一種手套消毒方案，為無菌操作中手套的使用設定了有效的基準（2）。在他的文章中，討論了手套選擇、穿戴過程設計、手套消毒、潔凈室物品處理和操作評估等每個要素的重要性，以及與無菌手套處理相關的數據。如前所述，這篇文章主要參考的是在醫療環境中進行的研究，只有少數涉及制藥無菌操作實踐。

 

Based upon over 40 years of pharmaceutical aseptic clean room operations management, I have observed years of employee gowning test data and have found that there are exceptionally low rates of glove and gown contamination when effective employee training and disciplined aseptic practices are maintained.

基于 40 多年的制藥無菌潔凈室運營管理經驗，我觀察了多年的員工穿戴測試數據，發現當進行有效的員工培訓并保持嚴格的無菌操作規范時，手套和工作服的污染率極低。

 

There is, however, a prerequisite for this conclusion that is based upon effective facility and process designs, a comprehensive contamination control process, effective maintenance of all cleanrooms and support operations, and purchase of high - quality sterile components, supplies, and materials needed to effectively manufacture a sterile drug or biologic product.

然而，這個結論有一個前提條件，即基于有效的設施和工藝設計、全面的污染控制流程、所有潔凈室和支持性操作的有效維護，以及購買有效生產無菌藥品或生物制品所需的高質量無菌組件、用品和材料。

 

Proposal

建議

 

Looking at the data presented in this article, I propose that handwashing becomes a five-step process and that donning sterile gloves as part of cleanroom gowning follow a nine-step process in which they are only sanitized with IPA based upon contact with less-than-sterile surfaces. There are some proponents of IPA-only hand washing. However, due to the limitations of IPA in removing soil and some viruses from hands, a hybrid approach is more appropriate to address all issues of soil and microbial bioburden reduction.

根據本文所提供的數據，我建議將洗手過程設定為五個步驟，而作為潔凈室著裝一部分的無菌手套穿戴則遵循九個步驟，且僅在接觸非無菌表面后使用異丙醇（IPA）進行消毒。有一些人支持僅使用異丙醇洗手，但由于異丙醇在去除手上污垢和某些病毒方面存在局限性，采用混合方法更適合解決減少污垢和微生物負荷的所有問題。

 

Handwashing (Anywhere within a pharmaceutical facility or upon entry into a gowning cleanroom):

洗手（在制藥設施內的任何地方或進入更衣室時）：

 

Rinse hands with hot water (85 – 100°F or 29 – 38°C) for 4 – 5 seconds.

用溫水（85 - 100 華氏度或 29 - 38 攝氏度）沖洗雙手 4 - 5 秒。

Use hand soap to wash hands with hot water for 20 seconds, washing all surfaces of the hands: front, back and between the fingers.

用洗手液和溫水洗手 20 秒，清洗雙手的所有表面，包括手心、手背和手指間。

Rinse hands with hot water until soap is not visible on hands.

用溫水沖洗雙手，直到手上看不到肥皂。

Dry hands with a hot-air dryer designed for cleanroom use or low particulate sterile wipe.

用潔凈室專用的熱風干手器或低顆粒無菌擦拭巾擦干雙手。

Spray hands with 4 – 5 mL of IPA and maintain wet for one minute. Let the hands air dry.

向雙手噴灑 4 - 5 毫升異丙醇，保持濕潤一分鐘，然后讓雙手自然風干。

 

Sterile glove sanitization:

無菌手套消毒：

 

Liberally spray the outer package of sterile gloves with IPA and maintain wet contact time for one minute.

用異丙醇充分噴灑無菌手套的外包裝，保持濕潤接觸時間一分鐘。

Don 1st pair of sterile gloves (Darker color) following the PDA recommended procedure used by the PDA Aseptic Process Training Courses.

按照 PDA 無菌工藝培訓課程推薦的程序，戴上第一雙無菌手套（顏色較深）。

Spray IPA to saturate gloves and let air dry.

噴灑異丙醇使手套濕透，然后讓其自然風干。

Don sterile apparel required for aseptic operations.

穿上無菌操作所需的無菌服裝。

Spray IPA to saturate gloves and let air dry.

再次噴灑異丙醇使手套濕透，然后讓其自然風干。

Don 2nd pair of sterile gloves (Lighter color).

戴上第二雙無菌手套（顏色較淺）。

Spray IPA to saturate glove and let air dry.

噴灑異丙醇使手套濕透，然后讓其自然風干。

Enter cleanroom environment and perform work duties. Only sanitize the gloves after touching non-sterile surfaces or component containers (2-3).

進入潔凈室環境并開始工作。僅在接觸非無菌表面或部件容器后對雙手進行消毒（2 - 3 次）。

Examine gloves every 15 – 30 minutes or after strenuous manipulation for perforations and replace as needed.

每 15 - 30 分鐘或在劇烈操作后檢查手套是否有穿孔，并根據需要進行更換。

 

Different disinfection methods should be based on the microorganism bioburden, organic and inorganic residues, and the criticality of the processes being performed in a pharmaceutical cleanroom. Handwashing is a critical first step to reduce the bioburden of hands, which are subsequently used to handle gown components. Handwashing minimizes the risk of contamination of the first pair of sterile gloves, which subsequently contact the sterile components of garments used to envelop the persons working in the pharmaceutical cleanrooms. The proposed five-step uniform process will reduce the incidence of contamination events that are detected during environmental monitoring and reduce the risk of contamination in injectable drug products.

不同的消毒方法應根據微生物負荷、有機和無機殘留物以及制藥潔凈室中正在進行的工藝的關鍵程度來選擇。洗手是降低手部生物負荷的關鍵第一步，之后手部會用于處理工作服組件。洗手可將第一雙無菌手套被污染的風險降至最低，而這雙手套隨后會接觸到用于包裹在制藥潔凈室工作的人員的無菌服裝組件。所提議的五步統一流程將降低環境監測中檢測到的污染事件發生率，并降低注射藥品的污染風險。

 

References

參考文獻

 

Ian Ross, PhD Sarah Bick, MSc Philip Ayieko, PhD Robert Dreibelbis, PhD, Jennyfer Wolf, PhD, Prof Matthew C Freeman, PhD et al. Effectiveness of handwashing with soap for preventing acute respiratory infections in low-income and middle-income countries: a systematic review and meta-analysis. Lancet Volume 401, Issue 10389 p1681-1690, May 20, 2023 Open access.

伊恩?羅斯博士、莎拉?比克碩士、菲利普?阿耶科博士、羅伯特?德賴貝爾比斯博士、珍妮弗?沃爾夫博士、馬修?C?弗里曼教授等。用肥皂洗手預防低收入和中等收入國家急性呼吸道感染的有效性：系統評價和薈萃分析。《柳葉刀》第 401 卷，第 10389 期，第 1681 - 1690 頁，2023 年 5 月 20 日，開放獲取。

Tim Sandle. Glove disinfection and aseptic technique: Creating a schema for the cleanroom and laboratory. EJPPS. 282 (2023) | https://doi.org/10.37521/ejpps.28201

蒂姆?桑德爾。手套消毒和無菌技術：為潔凈室和實驗室創建一個方案。《歐洲腸胃外與制藥科學雜志》2023 年第 282 期 | https://doi.org/10.37521/ejpps.28201

PDA Aseptic Processing Training Courses; https://pda.org/global-event-calendar/training/pda-aseptic-processing-training-courses

PDA 無菌工藝培訓課程；https://pda.org/global-event-calendar/training/pda-aseptic-processing-training-courses