近日，PDA在PDA-letter上发表了关于 如何洗手/手消，及如何穿戴无菌手套 的文章——《控制手部污染的最佳方法是什么？》，并给出洁净室洗手、手消和穿戴无菌手套的详细操作的建议，如下：

 

洗手（在制药设施内的任何地方或进入更衣室时）：

 

用温水（85 - 100 华氏度或 29 - 38 摄氏度）冲洗双手 4 - 5 秒。

用洗手液和温水洗手 20 秒，清洗双手的所有表面，包括手心、手背和手指间。

用温水冲洗双手，直到手上看不到肥皂。

用洁净室专用的热风干手器或低颗粒无菌擦拭巾擦干双手。

向双手喷洒 4 - 5 毫升异丙醇，保持湿润一分钟，然后让双手自然风干。

 

无菌手套消毒：

 

用异丙醇充分喷洒无菌手套的外包装，保持湿润接触时间一分钟。

戴上第一双无菌手套（颜色较深）。

喷洒异丙醇使手套湿透，然后让其自然风干。

穿上无菌操作所需的无菌洁净服。

再次喷洒异丙醇使手套湿透，然后让其自然风干。

戴上第二双无菌手套（颜色较浅）。

喷洒异丙醇使手套湿透，然后让其自然风干。

进入洁净室环境并开始工作。仅在接触非无菌表面或部件容器后对双手进行消毒（2 - 3 次）。

每 15 - 30 分钟或在剧烈操作后检查手套是否有穿孔，并根据需要进行更换。

 

翻译如下：

 

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 员工作者大卫・贾沃斯基，MBA

 

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

一个多世纪以来，洗手一直是药品生产良好卫生规范的重要组成部分。

 

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，无菌药品生产人员在穿戴洁净服前和佩戴无菌手套时，有很多方法来清洁和消毒双手。洗手方式已从简单的用温水洗手演变为复杂的流程，比如洗手并洗至肘部的前臂至少 30 秒、清洁指甲下方，并用低绒一次性毛巾或湿巾擦干。使用 70% 异丙醇（IPA）也已成为一种替代洗手的做法，从简单地在手上喷洒酒精，到将手完全浸泡在异丙醇中，用无菌湿巾擦干手，然后再使用异丙醇，然后让手自然风干。

 

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.

在过去 30 年里，无菌操作人员在进行无菌工作时，对外层（第二双）无菌手套频繁使用异丙醇已逐渐成为一种标准做法。在疫情期间，关于用肥皂和水还是异丙醇洗手消毒以预防病毒传播哪种方式更好存在很大争议。争论中所依据的证据支持不同立场，没有一种做法能提供 100% 的可靠性。无菌生产中也存在同样的情况。本文将回顾相关证据，并就穿戴洁净服前清洁和消毒双手的最佳流程，以及是否需要经常往无菌手套上使用无菌异丙醇给出建议。

 

A Review of the Available Literature

现有文献综述

 

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.

在研究了相关文献（115 项研究和参考文献）后发现，许多关于洗手和使用酒精消毒双手的研究并不规范，无法用于确定这两种方法的真正有效性。许多研究是在医疗环境中进行的，而在制药无菌洁净室中的研究很少。只有四项已发表的研究考察了无菌洁净室操作中的洗手情况，其中两项研究是在配制操作中进行的。

 

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，基恩等人进行了一项对照研究，以确定在小鼠手术后用 70% 异丙醇接触 30 秒对手术手套和器械进行消毒，是否能使相同的手套和器械在不进行灭菌的情况下重复使用。研究发现，用异丙醇对手套和器械进行消毒，可使手套在多达五次小鼠手术中免受细菌污染，并且在研究过程中使用相同器械时，只有两个手术器械样本受到污染。在消毒前对手套进行术后采样发现，在使用异丙醇消毒前，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.

在所有对照组和实验组中，每次手术前对高压灭菌器械和无菌手术手套进行检测，均未发现细菌生长。

 

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.

医院设备受病毒污染导致的临床不良事件促使里贝罗等人研究用 70% 异丙醇对设备表面进行消毒。虽然这项研究没有专门关注手部或手套的消毒，但它确实提供了一些在制定手部和手套消毒程序时可被认为重要的信息。该研究发现，用异丙醇在材料表面擦拭 10 秒进行消毒后，在进行的 282 次有效性测试中有 104 次（36.9%）检测到微生物，在 92 次功效测试中有 23 次（25.0%）检测到微生物。现场研究发现，在之前清洁过的 218 种产品中，有 74 种（33.9%）未达到消毒效果。在对照实验室研究中，异丙醇消毒对 30 种产品中的 11 种（36.7%）和 62 种非无菌产品中的 12 种（19.4%）无效。

 

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.

实验发现，用异丙醇擦拭 10 秒可有效消除单纯疱疹病毒，但在样本中发现了 5 型腺病毒。腺病毒是一组容易感染人类的 DNA 病毒，可引起普通感冒和其他病毒感染。一种 8 型腺病毒在接触眼压计的患者中引发了流行性角结膜炎爆发，尽管眼压计用 70% 异丙醇进行了清洁。

 

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.

该研究得出结论，用异丙醇擦拭 10 秒的程序对于消毒半关键器械上的微生物污染并不安全。不同的消毒方法应根据微生物负荷、有机和无机残留物以及被消毒器械的类型来选择。这警示我们，根据污垢负荷情况，用异丙醇在手套上擦拭 10 秒可能无法有效对手套进行消毒。

 

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，安德森等人进行了一项关于各种洗手方法对包膜病毒和非包膜病毒效果的研究，该研究采用了严格控制的逆转录定量聚合酶链式反应（RT-qPCR）测试程序，是已发现的关于洗手的最佳研究之一。研究发现，在实验室环境中，几种替代洗手方法（但并非全部）在去除和灭活病毒替代物方面与用肥皂和水洗手 20 秒的效果相同。用肥皂水和单独用水洗手 20 秒的测试数据与用肥皂和水洗手 20 秒相似。此外，研究发现用异丙醇对手进行消毒对包膜病毒有效，但对非包膜病毒无效，这与之前的实验室研究预期相符。测试结果还发现，用毛巾洗手的方法无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・纳森等人在医院对护士进行的一项有趣研究发现，使用 0.175% 对氯间二甲苯酚 / 0.3% 水杨酸肥皂洗手与用 70% 乙醇擦手在减少手部生物负荷方面没有显著差异。使用洗手方法时，总菌落数平均减少 59.5%，使用 70% 乙醇擦手时减少 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.

对护士进行的基线检测发现，10 个样本（47.62%）中有表皮葡萄球菌，6 个样本（28.75%）中有凝固酶阴性葡萄球菌（CoNS），2 个样本（9.52%）中有枯草芽孢杆菌，2 个样本（9.52%）中有产酸克雷伯菌，1 个样本（4.76%）中含有大肠杆菌。使用 70% 乙醇擦手后，测试样本中未发现产酸克雷伯菌和大肠杆菌，但仍在 10 个样本（55.55%）中发现了表皮葡萄球菌，6 个样本（33.33%）中发现了凝固酶阴性葡萄球菌，2 个样本（11.12%）中发现了枯草芽孢杆菌。这些发现支持了在无菌操作中佩戴无菌手套的要求，因为即使洗手或用酒精擦手可降低生物负荷，但洗手后双手并非无菌状态。

 

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.

美国食品药品监督管理局（FDA）的《农产品安全规则》提供了与制药卫生计划类似的通用指南。一项针对农场工人的研究表明，需要有效的洗手程序来减少微生物污染。虽然普林斯 - 格拉等人进行的研究考察的是污染严重的手，但所评估的程序为在制药行业中的应用提供了良好的基础。

 

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.

农场工人在收获不同农产品时，手上的污垢浓度和一些细菌指标存在显著差异。在不进行手部卫生清洁的情况下，观察到细菌浓度为 0.88 - 5.1 log10 CFU / 手，并且污垢负荷与细菌浓度之间存在中等相关性（ρ = -0.41 - 0.56）。研究数据发现，在减少农场工人手上的细菌方面，两步式异丙醇干预与用肥皂和水洗手的效果相当，但洗手并不总是能降低手上的生物负荷。

 

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.

农场工人洗手的方式是在饮用水下冲洗双手，将 2 毫升非抗菌洗手液涂抹在手上揉搓约 15 - 20 秒，再用饮用水冲洗，然后用一次性纸巾擦干双手。

 

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.

两步式异丙醇擦拭过程是先将 3 - 4.5 毫升（两到三泵）异丙醇涂抹在手上。揉搓双手约 15 - 20 秒后，用一次性纸巾擦掉多余的异丙醇。最后，再挤出一泵异丙醇，工人双手揉搓直至干燥。

 

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.

结果显示，与对照组相比，洗手可使手部微生物生物负荷降低约 1.4 log10，两步式异丙醇程序可使手部微生物生物负荷降低约 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.

美国食品药品监督管理局（FDA）的《食品安全现代化法案》中关于农产品安全的最终规定要求人员用肥皂和水洗手，但 FDA 的《农产品安全规则》明确指出，“不得使用抗菌擦手液替代肥皂（或其他有效表面活性剂）和水”，因为当人们手上有污垢、油脂时，抗菌擦手液无法有效去除细菌。普林斯 - 格拉等人假设，农场工人洗手前手上的污垢和微生物的数量及类型可能会影响不同手部卫生方法减少微生物污染的效果，他建议 FDA 关于农产品安全的最终规定应允许在无法用肥皂和水洗手的地方使用两步式异丙醇手部消毒程序。

 

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，在设计制药用卫生计划时需要基于科学的灵活性。

 

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.

众所周知，人们洗手的情况并不一致。陈石等人进行的一项观察视频和污垢去除研究强调了在对 664 名受试者的 744 个视频进行观察并根据观察到的行为进行评分时发现的差异。

 

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

个人洗手效果通过每个受试者手背和手掌区域残留荧光凝胶的百分比来量化。

 

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.

手指间揉搓是最常被遗漏的步骤，而揉搓手指背是最常做错的步骤。在考虑了与洗手相关的所有变量后，冲洗时揉搓双手和冲洗时间与洗手效果显著相关。最佳的整体洗手时间是 31 秒，除了手指间揉搓外，每个步骤理想情况下持续 4 - 5 秒。双手掌心的荧光残留比手背少。出现残留的区域依次是手腕、指尖、指缝和拇指。

 

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.

这项研究强调了进行有效人员培训的必要性，以便按照一致的逐步流程洗手，强调不允许走捷径。培训人员在培训制药人员时，可以将洗手前涂抹在手上的荧光凝胶作为一种有价值的工具。

 

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・罗斯博士进行的一项关于用肥皂洗手预防急性呼吸道感染有效性的荟萃分析支持了前面讨论的研究结果，即在低收入和中等收入国家的医疗环境中实施干预性洗手后，感染发生率有所降低（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.

劳里・M・史密斯等人进行的一项有争议的研究《戴手套和不戴手套后洁净室操作人员服装表面细菌污染的比较》发现，穿戴洁净室服装后有明显的污染。这项研究仅对 27 次操作人员穿戴服装的事件进行了采样，包括戴手套和不戴手套的情况。令人惊讶的是，在穿戴后，在服装背部中间观察到了污染。然而，关于操作人员所接受的培训、他们的资质结果或观察到的穿戴操作规范的信息很少。此外，在穿戴过程的每一步之后，对于使用异丙醇对装衣服的包装、洁净室的工作台或手套进行消毒的问题也没有讨论。这篇文章还提出，裸手、非无菌手套或无菌洁净室手套对操作人员服装的细菌污染水平没有差异。鉴于上述缺陷，这项研究应该使用更大的样本量并遵循当前制药无菌穿戴规范重新进行。

 

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.

在佩戴无菌手套方面，手术中心对一些常见的误解进行了研究。丹妮丝・科尔涅维奇和马赫・埃尔 - 马斯里探讨了手术中戴双层手套的好处以及洁净室手套使用中的人为因素。他们进行了一项为期 24 个月的研究，发现无菌手套在佩戴过程中会随着时间推移出现微小穿孔。戴两层手套的过程需要精心设计，要注意所购买无菌手套的类型和品牌，以保持灵活性和穿戴便利性。该研究还发现，在戴双层手套时使用不同颜色的手套可以更早发现穿孔并及时更换手套，从而降低污染风险。

 

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・桑德尔博士在 2023 年提出了一种手套消毒方案，为无菌操作中手套的使用设定了有效的基准（2）。在他的文章中，讨论了手套选择、穿戴过程设计、手套消毒、洁净室物品处理和操作评估等每个要素的重要性，以及与无菌手套处理相关的数据。如前所述，这篇文章主要参考的是在医疗环境中进行的研究，只有少数涉及制药无菌操作实践。

 

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 多年的制药无菌洁净室运营管理经验，我观察了多年的员工穿戴测试数据，发现当进行有效的员工培训并保持严格的无菌操作规范时，手套和工作服的污染率极低。

 

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，这个结论有一个前提条件，即基于有效的设施和工艺设计、全面的污染控制流程、所有洁净室和支持性操作的有效维护，以及购买有效生产无菌药品或生物制品所需的高质量无菌组件、用品和材料。

 

Proposal

建议

 

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.

根据本文所提供的数据，我建议将洗手过程设定为五个步骤，而作为洁净室着装一部分的无菌手套穿戴则遵循九个步骤，且仅在接触非无菌表面后使用异丙醇（IPA）进行消毒。有一些人支持仅使用异丙醇洗手，但由于异丙醇在去除手上污垢和某些病毒方面存在局限性，采用混合方法更适合解决减少污垢和微生物负荷的所有问题。

 

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

洗手（在制药设施内的任何地方或进入更衣室时）：

 

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

用温水（85 - 100 华氏度或 29 - 38 摄氏度）冲洗双手 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.

用洗手液和温水洗手 20 秒，清洗双手的所有表面，包括手心、手背和手指间。

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

用温水冲洗双手，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.

用洁净室专用的热风干手器或低颗粒无菌擦拭巾擦干双手。

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

向双手喷洒 4 - 5 毫升异丙醇，保持湿润一分钟，然后让双手自然风干。

 

Sterile glove sanitization:

无菌手套消毒：

 

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

用异丙醇充分喷洒无菌手套的外包装，保持湿润接触时间一分钟。

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

按照 PDA 无菌工艺培训课程推荐的程序，戴上第一双无菌手套（颜色较深）。

Spray IPA to saturate gloves and let air dry.

喷洒异丙醇使手套湿透，然后让其自然风干。

Don sterile apparel required for aseptic operations.

穿上无菌操作所需的无菌服装。

Spray IPA to saturate gloves and let air dry.

再次喷洒异丙醇使手套湿透，然后让其自然风干。

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

戴上第二双无菌手套（颜色较浅）。

Spray IPA to saturate glove and let air dry.

喷洒异丙醇使手套湿透，然后让其自然风干。

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

进入洁净室环境并开始工作。仅在接触非无菌表面或部件容器后对双手进行消毒（2 - 3 次）。

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

每 15 - 30 分钟或在剧烈操作后检查手套是否有穿孔，并根据需要进行更换。

 

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.

不同的消毒方法应根据微生物负荷、有机和无机残留物以及制药洁净室中正在进行的工艺的关键程度来选择。洗手是降低手部生物负荷的关键第一步，之后手部会用于处理工作服组件。洗手可将第一双无菌手套被污染的风险降至最低，而这双手套随后会接触到用于包裹在制药洁净室工作的人员的无菌服装组件。所提议的五步统一流程将降低环境监测中检测到的污染事件发生率，并降低注射药品的污染风险。

 

References

参考文献

 

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・罗斯博士、莎拉・比克硕士、菲利普・阿耶科博士、罗伯特・德赖贝尔比斯博士、珍妮弗・沃尔夫博士、马修・C・弗里曼教授等。用肥皂洗手预防低收入和中等收入国家急性呼吸道感染的有效性：系统评价和荟萃分析。《柳叶刀》第 401 卷，第 10389 期，第 1681 - 1690 页，2023 年 5 月 20 日，开放获取。

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・桑德尔。手套消毒和无菌技术：为洁净室和实验室创建一个方案。《欧洲肠胃外与制药科学杂志》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 无菌工艺培训课程；https://pda.org/global-event-calendar/training/pda-aseptic-processing-training-courses

 

来源：Internet

关键词： 洁净室