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.潔凈室常見污染物包括固體灰塵、液體、細菌、真菌、人體皮膚細胞和毛發、微量水分、溢出物和滲漏物、化妝品、香水、絨毛、纖維等。絕大多數潔凈室污染物都來自于在其中工作的人員。

Cleanroom design and construction address contamination in a few ways:

潔凈室的設計和構造通過以下幾種方式解決污染問題：

Preventing particle entry from air filtration systems or air gaps

防止顆粒從空氣過濾系統或空氣間隙進入

Purging and filtering room air throughout the production process

在整個生產過程中對室內空氣進行凈化和過濾

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

設置不同潔凈度的并行區域和相鄰房間，例如：用于穿戴潔凈服的更衣間、用于準備和存儲的級聯前室和緩沖室

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

層流罩內的隔離潔凈空間和氣壓，用于無菌配藥或危險化學品等隔離操作

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

進入室、更衣間、前室的最佳實踐

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

進入潔凈室的區域至少應與潔凈室本身一樣潔凈

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

所有個人物品，如鑰匙、手表、戒指、火柴、打火機和香煙等，應存放在更衣室外的個人儲物柜中

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

在更衣間入口處放置粘塵墊，并在附近設置廢物容器，用于丟棄飽和的粘塵墊

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

手表、珠寶和所有衣物應存放在更衣間的 “較污染一側”

Don’t smoke 30 minutes before entering.

進入前 30 分鐘內禁止吸煙

Hand Washing Best Practices for Cleanrooms

潔凈室洗手最佳實踐

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.

在潔凈室中戴手套是標準操作，手部衛生不佳會增加潔凈室受細菌污染的風險，并可能導致病毒、真菌等微生物的傳播或引入。

How to Wash Hands with Soap & Water in a Cleanroom

潔凈室中用肥皂/洗手液和水洗手的方法

Wet hands first with water, then apply soap

先用水濕潤雙手，然后涂抹肥皂/洗手液

Apply the manufacturer recommended amount of soap

按照制造商建議的用量使用肥皂/洗手液

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

禁止使用紙巾，應使用配備 HEPA 過濾器的干手器

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

搓洗雙手至少 15 秒，并覆蓋手部所有表面

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

避免使用熱水，以免增加患皮炎的風險

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

了解員工關于任何香料或刺激性問題的反饋

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

徹底洗手前，切勿觸摸潔凈的衣物或潔凈材料

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

對于 EPA（靜電防護區域）潔凈室，應使用 ESD 護膚液，因為標準護膚液可能會影響 ESD 腕帶和監測站的有效性

Keep natural fingernails less than 1/4″ long

保持自然指甲長度不超過0.6cm

Monitor the volume of use for alcohol based hand rubs

監控酒精類洗手液的使用量

Cleanroom Gloves

潔凈室手套

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.

潔凈室手套的佩戴有兩個原因：一是保護佩戴者免受危險或刺激性物質的接觸；二是保護潔凈室產品免受操作人員、設備或空氣中顆粒帶來的污染。制藥商通常要求無菌手套采用潔凈室專用包裝。標準手術手套包裝通常使用聚纖維素紡粘織物，在打開和處理時會產生大量顆粒。潔凈室手套包裝采用聚乙烯易開啟包裝，經去離子水清洗，在A級環境中組裝。

Best Practices for Donning Cleanrooms Gloves

佩戴潔凈室手套的最佳實踐

You Should:

應該做：

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

在潔凈室和無菌操作中使用無菌手套，絕不要使用粉末手套

Dry hands completely before donning gloves

戴手套前確保雙手完全干燥

Don dominant hand first

先戴優勢手（常用手）

Use wall mount consumable dispenser for easy access      and less movement

可以使用壁掛式分配器，方便取用，減少移動

You Should Not:

不應該做：

Wear jewelry, fingernail polish, or cosmetics.

佩戴珠寶、指甲油或化妝品

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

使用酒精后，不要揮舞戴手套的手來加速干燥

Never touch exposed skin with a gloved hand.

勿用戴手套的手觸摸裸露的皮膚

Cleanroom Gowning Procedure and Protocol

潔凈室更衣程序和規范

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.

潔凈室更衣規范因潔凈室等級和應用而異。被歸類為C級或B級（或更高級別）的潔凈室則需要潔凈服連體服，以及頭罩、手套和鞋套。對于無菌操作，需要額外注意，確保在更衣、操作或清潔過程中，無菌表面不會接觸到非無菌表面。

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

最后，高危害潔凈室（如三級實驗室）在無菌和非無菌環境下都有操作，因此更衣順序也有所不同。

Cleanroom Gowning Procedure Checklist

潔凈室更衣程序清單

Before entering gowning room taking at least three small steps with each foot; remove dirty sticky mat layer if needed.進入更衣間前，每只腳至少在粘塵墊上踩三下；必要時移除較臟的粘塵墊層

Don shoe cover booties穿上鞋套

Don cleanroom bouffant戴上潔凈室圓帽

Wash hands thoroughly徹底洗手

Put on cleanroom glove liners戴上潔凈室手套內襯

Apply alcohol solution to outside of liners向內襯外側涂抹酒精溶液

Put on cleanroom gloves戴上潔凈室手套

Wash or apply alcohol solution to cleanroom gloves清洗或向潔凈室手套涂抹酒精溶液

Apply cleanroom bouffant (beard covers for those with facial hair) 戴上潔凈室圓帽（有胡須者需戴胡須罩）

Apply a freshly laundered cleanroom hood戴上新洗過的潔凈室頭罩

Attach facemask戴上口罩/面罩

Apply coveralls, only touch the floor on the clean side of a gowning bench穿上連體服，只接觸更衣凳的潔凈側

Hoods are tucked inside of coveralls將頭罩塞進連體服內

Put on cleanroom booties穿上潔凈室鞋套

Put on cleanroom gloves戴上潔凈室手套

Ensure that booties and gloves overlap the coveralls確保鞋套和手套包裹連體服

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

Use cleanroom mirror for self-check使用潔凈室鏡子進行自我檢查

Personnel Cleansing and Garbing Best Practices

人員清潔和更衣最佳實踐

You Should:

應該做：

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

讓員工參與質量保證過程，并向他們通報衛生或程序評估的正面和負面結果

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

在前期房間進行仔細徹底的手部清潔是必不可少的衛生措施，且要在穿上不脫落纖維的潔凈服之前完成

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

確保各種身材和體型的操作人員都能獲得合身的服裝

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)

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

You Should Not

不應該做：

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

不要用刷子擦洗雙手，因為任何皮膚損傷都會增加皮膚脫落

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帶有 HEPA 過濾功能的電子干手器外，不要使用任何類型的干擦布

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.

在完成適當的手部衛生前，不要穿上潔凈服，因為穿著不脫落纖維的潔凈服時，水槽濺出的水可能成為微生物污染的來源。