A sterile room is usually a small room dedicated to the microbiology laboratory. It can be constructed with boards and glass. The area should not be too large, about 4- is sufficient, and the height is about 2.5. A buffer room should be set up outside the sterile room, and the doors of the buffer room and the sterile room should not face in the same direction to prevent the airflow from bringing in miscellaneous bacteria. Both the sterile room and buffer room must be sealed. Indoor ventilation equipment must have air filtration devices.

二

two

生物無菌室主要控制有生命微粒與無生命微粒（塵埃）對工作對象的污染；而生物潔凈室又可分為：

The biological sterile room mainly controls the pollution of living and inanimate particles (dust) on the working objects; And the biological clean room can be divided into:

一般生物無菌室主要控制微生物對象的污染。同時其內部材料要能經受各種劑侵蝕，內部一般保證正壓。實質上其內部材料要能經受各種處理的工業潔凈室。例：制藥工業醫院（手術室無菌病房）食品化妝品飲料產品生產動物實驗室理化檢驗室血站等。

The general biological sterile room mainly controls the pollution of microbial objects. At the same time, its internal materials must be able to withstand various agents' erosion, and the internal pressure is generally guaranteed to be positive. Essentially, its internal materials need to be able to withstand various treatments in an industrial clean room. Example: Pharmaceutical Industry Hospital (Operating Room Sterile Ward) Food, Cosmetics and Beverage Product Production Animal Laboratory Physical and Chemical Laboratory Blood Station, etc.

生物學無菌室主要控制工作對象的有生命微粒對外界和人的污染。內部要保持與大氣的負壓。例：**學生物學潔凈實驗室物物工程（重組基因疫苗制備）。

The biological sterile room mainly controls the pollution of living particles to the outside world and humans. Maintain negative pressure internally with the atmosphere. Example: * * Biology Clean Laboratory Material Engineering (Preparation of Recombinant Gene Vaccine).

工業以無生命微粒的控制為對象。主要控制空氣塵埃微粒對工作對象的污染，內部一般保持正壓狀態。 它適用于精密機械工業電子工業（半導體集成電路等）宇航工業高純度化學工業原子能工業光磁產品工業（光盤膠片磁帶生產）LCD（液晶玻璃）電腦硬盤電腦磁頭生產等多行業。

Industry targets the control of inanimate particles. Mainly controls the pollution of air dust particles on the working object, and generally maintains a positive pressure state internally. It is suitable for various industries such as precision machinery industry, electronic industry (semiconductor integrated circuits, etc.), aerospace industry, high-purity chemical industry, atomic energy industry, optical and magnetic product industry (optical disc film and tape production), LCD (liquid crystal glass), computer hard disk, computer magnetic head production, etc.

三藥品潔凈無塵室的三態原則：

Three state principles for clean and dust-free rooms with three drugs:

空態無菌室已經建造完成并可以投入使用的潔凈室（設施）。它具備所有有關的服務和功能。但是，在設施內沒有操作人員操作的設備。

A clean room (facility) where an empty sterile room has been constructed and can be put into use. It has all relevant services and functions. However, there are no equipment operated by operators within the facility.

靜態無菌室各種功能完備設定安裝妥當，可以按照設定使用或正在使用的潔凈室（設施），但是設施內沒有操作人員。

The various functions of the static sterile room are fully set and installed, and can be used according to the settings or the clean room (facility) in use, but there are no operators in the facility.

動態無菌室處于正常使用的潔凈室，服務功能完善，有設備和人員；如果需要，可從事正常的工作。

The dynamic sterile room is in a clean room that is in normal use, with complete service functions, equipment, and personnel; If necessary, can engage in normal work.

四 無菌藥品生產環境的空氣潔凈度級別要求：

Air cleanliness level requirements for sterile drug production environments:

*終**藥品：100級或10 000級背景下的局部100級：

*Final drug: Local level 100 under the background of level 100 or 10000:

大容量注射劑（>50毫升）的灌封；10 000級：注射劑的稀配 濾過；小容量注射劑的灌封；直接接觸藥品的包裝材料的*終處 理。100 000級：注射劑濃配或采用密封系統的稀配。

Filling and sealing of large volume injections (> 50 milliliters); Grade 10000: Diluted filtration of injection; Sealing of small volume injections; Final treatment of packaging materials that come into direct contact with drugs. Class 100000: Injection concentrated or diluted using a sealed system.

非*終**藥品：100級或10 000級背景下局部100級：

Non final * * drugs: Local level 100 in the context of level 100 or 10000:

灌裝前不需**濾過的藥液配制；注射劑的灌封分裝和壓塞；直V型大風量過濾器接接觸藥品的包裝材料*終處理后的暴露環境。10 000級：灌裝 前需**濾過的藥液配制。100 000級：軋蓋，直接接觸藥品的包 裝材料*后一次精洗的*低要求。

Preparation of filtered solution is not required before filling; Filling, packaging, and tamping of injections; The exposure environment after the final treatment of the packaging material of the direct V-shaped high air volume filter in contact with the drug. Grade 10 000: Preparation of filtered solution is required before filling. Level 100000: Low requirements for capping, packaging materials that come into direct contact with drugs, and subsequent fine cleaning.

其他無菌藥品：10 000級：供角膜創傷或手術用滴眼劑 的配制和灌裝。

Other sterile drugs: Grade 10000: Preparation and filling of eye drops for corneal trauma or surgery.

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