Some of the most common cleanroom contamination include solid dust, liquid, bacteria, fungus, human skin cells and hair, trace moisture, spills and leaks, cosmetics, perfumes, lint, fibers, and more. The vast majority of cleanroom contamination comes from those that work within it.洁净室常见污染物包括固体灰尘、液体、细菌、真菌、人体皮肤细胞和毛发、微量水分、溢出物和渗漏物、化妆品、香水、绒毛、纤维等。绝大多数洁净室污染物都来自于在其中工作的人员。

Cleanroom design and construction address contamination in a few ways:

洁净室的设计和构造通过以下几种方式解决污染问题：

Preventing particle entry from air filtration systems or air gaps

防止颗粒从空气过滤系统或空气间隙进入

Purging and filtering room air throughout the production process

在整个生产过程中对室内空气进行净化和过滤

Providing parallel stages and adjacent rooms of differing cleanliness eg; gowning or garbing room for dressing and donning, cascaded anter and buffer rooms for preparation and storage

设置不同洁净度的并行区域和相邻房间，例如：用于穿戴洁净服的更衣间、用于准备和存储的级联前室和缓冲室

Isolated clean spaces and air pressure within laminar flow hoods for isolated procedures such as sterile compounding or hazardous chemicals

层流罩内的隔离洁净空间和气压，用于无菌配药或危险化学品等隔离操作

Best Practices for Entrance Rooms, Garment Rooms, Ante-rooms

进入室、更衣间、前室的最佳实践

The section leading into a cleanroom should be at least as clean as the room itself

进入洁净室的区域至少应与洁净室本身一样洁净

All personal items such as keys, watches, rings, matches, lighters and cigarettes should be stored in the personal locker outside the gowning room.

所有个人物品，如钥匙、手表、戒指、火柴、打火机和香烟等，应存放在更衣室外的个人储物柜中

Place a sticky mat at the entrance of a gowning room with a waste receptacle nearby for discarding saturated sticky tack layers

在更衣间入口处放置粘尘垫，并在附近设置废物容器，用于丢弃饱和的粘尘垫

Watches, jewelry, and any clothing should be stored on the “dirty” side of the gowning room.

手表、珠宝和所有衣物应存放在更衣间的 “较污染一侧”

Don’t smoke 30 minutes before entering.

进入前 30 分钟内禁止吸烟

Hand Washing Best Practices for Cleanrooms

洁净室洗手最佳实践

While wearing gloves in a cleanroom is standard practice, poor hand hygiene increase the vulnerability of cleanrooms to bacteria and potential transfer or introduction of microbes such as viruses and fungus.

在洁净室中戴手套是标准操作，手部卫生不佳会增加洁净室受细菌污染的风险，并可能导致病毒、真菌等微生物的传播或引入。

How to Wash Hands with Soap & Water in a Cleanroom

洁净室中用肥皂/洗手液和水洗手的方法

Wet hands first with water, then apply soap

先用水湿润双手，然后涂抹肥皂/洗手液

Apply the manufacturer recommended amount of soap

按照制造商建议的用量使用肥皂/洗手液

Use of paper towels is prohibited. Use HEPA equipped hand dryers

禁止使用纸巾，应使用配备 HEPA 过滤器的干手器

Scrub hands for at least 15 seconds, and cover all hand surfaces

搓洗双手至少 15 秒，并覆盖手部所有表面

Avoid using hot water, which may increase the risk of dermatitis

避免使用热水，以免增加患皮炎的风险

Do not add soap to a partially empty soap dispenser

不要向未用完的瓶子中添加肥皂/洗手液

Get input from employees about any fragrance or irritation issues

了解员工关于任何香料或刺激性问题的反馈

Never touch a clean garment of clean material before thorough hand washing

彻底洗手前，切勿触摸洁净的衣物或洁净材料

For EPA (electrostatic protected areas) cleanrooms, apply an ESD lotion, as standard lotions may compromise the effectiveness of ESD wristbands and monitoring stations

对于 EPA（静电防护区域）洁净室，应使用 ESD 护肤液，因为标准护肤液可能会影响 ESD 腕带和监测站的有效性

Keep natural fingernails less than 1/4″ long

保持自然指甲长度不超过0.6cm

Monitor the volume of use for alcohol based hand rubs

监控酒精类洗手液的使用量

Cleanroom Gloves

洁净室手套

Cleanroom gloves are worn for one of two reasons: to protect the wearer from exposure to dangerous or irritative substances, and to protect cleanroom products from contaminants introduced through operators, equipment, or airborne particles. Pharmaceutical manufacturers will generally require sterile gloves with cleanroom designated packaging. Standard surgical glove packaging generally uses a polycellulose spunwoven fabric which generates a high count of particles when opened and handled. Cleanroom glove packaging features a polyethylene, easy open packaging which is washed with deionized water, assembled in an ISO Class 4 cleanroom, and then packaged for delivery in an ISO Class 5 Cleanroom.

洁净室手套的佩戴有两个原因：一是保护佩戴者免受危险或刺激性物质的接触；二是保护洁净室产品免受操作人员、设备或空气中颗粒带来的污染。制药商通常要求无菌手套采用洁净室专用包装。标准手术手套包装通常使用聚纤维素纺粘织物，在打开和处理时会产生大量颗粒。洁净室手套包装采用聚乙烯易开启包装，经去离子水清洗，在A级环境中组装。

Best Practices for Donning Cleanrooms Gloves

佩戴洁净室手套的最佳实践

You Should:

应该做：

Usesterile gloves for cleanroom and aseptic processing, and never use powdered gloves.

在洁净室和无菌操作中使用无菌手套，绝不要使用粉末手套

Dry hands completely before donning gloves

戴手套前确保双手完全干燥

Don dominant hand first

先戴优势手（常用手）

Use wall mount consumable dispenser for easy access      and less movement

可以使用壁挂式分配器，方便取用，减少移动

You Should Not:

不应该做：

Wear jewelry, fingernail polish, or cosmetics.

佩戴珠宝、指甲油或化妆品

Do not wave gloved hands to speed drying after applying alcohol      solution.

使用酒精后，不要挥舞戴手套的手来加速干燥

Never touch exposed skin with a gloved hand.

勿用戴手套的手触摸裸露的皮肤

Cleanroom Gowning Procedure and Protocol

洁净室更衣程序和规范

Cleanroomgowning protocol differs depending on cleanroom class and application. In ISO Class 7 or ISO Class 8 cleanrooms, frocks are often acceptable. A cleanroom classified as ISO Class 5 or ISO Class 6 (or cleaner) requires cleanroom coveralls, along with hoods, gloves, and booties (shoe covers). For sterile processing, additional precaution is needed to assure that no sterile surfaces contact non-sterile surfaces during gowning, processing, or cleaning.

洁净室更衣规范因洁净室等级和应用而异。被归类为C级或B级（或更高级别）的洁净室则需要洁净服连体服，以及头罩、手套和鞋套。对于无菌操作，需要额外注意，确保在更衣、操作或清洁过程中，无菌表面不会接触到非无菌表面。

Finally, hazardous cleanrooms operate in both sterile and non-sterile realms, thus gowning order varies.

最后，高危害洁净室（如三级实验室）在无菌和非无菌环境下都有操作，因此更衣顺序也有所不同。

Cleanroom Gowning Procedure Checklist

洁净室更衣程序清单

Before entering gowning room taking at least three small steps with each foot; remove dirty sticky mat layer if needed.进入更衣间前，每只脚至少在粘尘垫上踩三下；必要时移除较脏的粘尘垫层

Don shoe cover booties穿上鞋套

Don cleanroom bouffant戴上洁净室圆帽

Wash hands thoroughly彻底洗手

Put on cleanroom glove liners戴上洁净室手套内衬

Apply alcohol solution to outside of liners向内衬外侧涂抹酒精溶液

Put on cleanroom gloves戴上洁净室手套

Wash or apply alcohol solution to cleanroom gloves清洗或向洁净室手套涂抹酒精溶液

Apply cleanroom bouffant (beard covers for those with facial hair) 戴上洁净室圆帽（有胡须者需戴胡须罩）

Apply a freshly laundered cleanroom hood戴上新洗过的洁净室头罩

Attach facemask戴上口罩/面罩

Apply coveralls, only touch the floor on the clean side of a gowning bench穿上连体服，只接触更衣凳的洁净侧

Hoods are tucked inside of coveralls将头罩塞进连体服内

Put on cleanroom booties穿上洁净室鞋套

Put on cleanroom gloves戴上洁净室手套

Ensure that booties and gloves overlap the coveralls确保鞋套和手套包裹连体服

Wipedown the gowning bench with a clean, sterile wiper用干净、无菌的擦拭布擦拭更衣凳

Use cleanroom mirror for self-check使用洁净室镜子进行自我检查

Personnel Cleansing and Garbing Best Practices

人员清洁和更衣最佳实践

You Should:

应该做：

Do include employees in the quality assurance process and keep them informed of positive and negative hygiene or procedure evaluations. 

让员工参与质量保证过程，并向他们通报卫生或程序评估的正面和负面结果

Careful and thorough hand cleansing is essential hygiene performed in the anteroom and prior to donning a non-shedding gown. 

在前期房间进行仔细彻底的手部清洁是必不可少的卫生措施，且要在穿上不脱落纤维的洁净服之前完成

Ensure that operators of all shapes and body sizes have access to properly fitting garments. 

确保各种身材和体型的操作人员都能获得合身的服装

Wash hands and forearms up to the elbows for at least 30 seconds with soap and water in the ante-area. (either non-antimicrobial or antimicrobial soap)

在前期区域用肥皂/洗手液和水清洗双手和前臂直至肘部，至少 30 秒（使用非抗菌或抗菌肥皂/洗手液均可）

You Should Not

不应该做：

Don’t use scrub brushes on the hands as any skin damage increases skin shedding.

不要用刷子擦洗双手，因为任何皮肤损伤都会增加皮肤脱落

Don’t use any type of drying wipe except disposable wipes or an electronic hand dryer with HEPA filtration

除了一次性擦拭布或带有 HEPA 过滤功能的电子干手器外，不要使用任何类型的干擦布

Don’t don a gown before completing      proper hand hygiene, as splashes from the sink while wearing a      non-shedding gown could be a source of microbial contamination.

在完成适当的手部卫生前，不要穿上洁净服，因为穿着不脱落纤维的洁净服时，水槽溅出的水可能成为微生物污染的来源。