1、按生產工藝流程布（bù）置。流程盡可能短，減少交叉往複，人流、物流走向合理。必須配備人員淨化（huà）室（存外衣室、盥洗（xǐ）室、穿潔（jié）淨工（gōng）作服室及緩衝（chōng）室）、物（wù）料淨化室（脫外包間、緩衝室和雙層傳遞窗），除配備產品工序要求的用室外（wài），還應配備潔具室、洗衣間、暫存室、工位器具清洗間等，每間用室相互獨立，潔（jié）淨車間的麵積應在保證基本要求前提（tí）下，與生產規模相適應。
1. According to the production process. The process should be as short as possible to reduce cross reciprocating, and the flow of people and logistics should be reasonable. It must be equipped with personnel purification room (coat storage room, washroom,
clean work clothes room and buffer room), material purification room (unpacking room, buffer room and double-layer transfer window). In addition to the room required for product process, it should also be equipped with sanitary ware room, laundry
room, temporary storage room, cleaning room for working equipment, etc. each room is independent of each other, and the area of clean workshop should be guaranteed to be basic Under the premise, it is suitable for the production scale.
2、按空氣（qì）潔淨度級別，可以寫成按人流方向，從低到高；車間是從內向外，由高到低。
2. According to the air cleanliness level, it can be written from low to high according to the direction of people flow; the workshop is from inside to outside, from high to low.
3、同一潔淨（jìng）室（區）內或相鄰潔淨室（區）間不產（chǎn）生交叉汙染生產過程（chéng）和原材料不會對產品質量產生相互影響；不同級別的潔淨室（區）之間有（yǒu）氣閘（zhá）室或防汙（wū）染（rǎn）措施，物料的傳送通過雙層傳遞窗。
3. There is no cross contamination in the same clean room (area) or between adjacent clean rooms (areas). The production process and raw materials will not affect the product quality; there are airlocks or anti pollution measures between clean rooms (areas)
of different levels, and materials are transported through double-layer transfer windows.
4、空氣淨化（huà）應符合GB 50457-2008《醫藥工業潔淨廠房設（shè）計規範》第九（jiǔ）章的要求。潔淨室裏的（de）新鮮空氣量，應取下列大值：
4. The air purification should meet the requirements of Chapter 9 of GB 50457-2008 code for design of clean workshop in pharmaceutical industry. The amount of fresh air in the clean room should be taken as follows:
1）補償室內排風量和保持（chí）室內正（zhèng）壓所需新鮮空氣量；
1) Compensation of indoor exhaust air volume and fresh air volume required for keeping indoor positive pressure;
2）室內沒（méi）人（rén）新鮮空（kōng）氣不應小（xiǎo）於40m3/h。
2) When there is no one in the room, the fresh air should not be less than 40m3 / h.
5、淨化車間人均麵積應不少於4mm（除走廊、設備等物品外），保證操作區域。
5. The per capita area of purification workshop shall not be less than 4mm (except for corridor, equipment and other items) to ensure the operation area.
6、如屬體外診斷試劑的應符合《體外診斷試劑生產實施細則（試行）》的要求。其中陰性、陽（yáng）性血清、質粒或血液製品的處理（lǐ）操作應當在至少萬級環境下進行，與相鄰區或保持相對（duì）負壓（yā），並符合（hé）防護要（yào）求。
6. If it is an in vitro diagnostic reagent, it shall meet the requirements of the implementation rules for in vitro diagnostic reagent production (Trial). Among them, the treatment of negative and positive serum, plasmid or blood products should be carried
out in an environment of at least ten thousand level, keep relative negative pressure with the adjacent area, and meet the protection requirements.
7、應標明回風、送風及製水（shuǐ）管道的（de）走向（xiàng）。
7. The direction of return air, supply air and water supply pipeline shall be indicated.
昆（kūn）山昌瑞空調淨化（huà）技術有限公司，專注從事
空氣過濾器係列產品（初/中/高效、化學過（guò）濾器等）、潔淨室淨（jìng）化（huà）設備（拋棄式/可更換式/自動卷繞式（shì）過濾（lǜ）器（qì）、
高效送風口、FFU高效過濾器淨化機組）的研發、生產、銷售和售後。
Changrui Air Conditioning Purification Technology Co., Ltd. focuses on the R&D, production, sales and after-sales of air filter series products (primary/medium/high-efficiency, chemical filters, etc.) and clean room purification equipment (disposable/replaceable/automatic
winding filters, high-efficiency air supply outlets, FFU high-efficiency filter purification units).
昌瑞空調（diào）手機網 
