控制潔凈廠房設計施工的微生物環境
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- 發布日期：2017-04-13 16:21:36
潔凈廠房設計施工分為生物潔凈室和非生物潔凈室兩種。生物潔凈室空氣凈化系統必須連續運轉；非生物潔凈室使用前空氣凈化系統應提前4小時開啟。檢測塵埃粒子用塵埃粒子計數器，在環境衛生清潔后緩沖0.5～1小時之后進行，為避免人為造成的污染，靜態測試時潔凈室內僅限兩人。注射劑的生產過程中應對關鍵控制點進行動態監控。
Clean room design and construction is divided into two kinds of biological clean room and clean room. Clean room air purification system must be continuous operation; non biological clean room before the use of the air purification system should be 4 hours ahead of time. Detection of dust particles with dust particles counter, in the environment after the buffer 0.5 ~ 1 hours after the buffer, in order to avoid the pollution caused by human, the static test of the clean room is only two people. Dynamic monitoring of key control points in the production process of injection.
微生物含量的控制?？刂茲崈羰噎h境中的微生物含量仍然是靠良好的空氣凈化系統設施，其過濾效率可以達到99.9%～99.99%地濾除空氣中的細菌和塵埃。生產中潔凈室內溫度嚴格控制在18～26℃、相對濕度控制在45%～65%，以破壞有利于細菌的生長條件，加之消毒液的清潔消毒，環境控制效果令人滿意。關于日常消毒液消毒，每天生產結束后，用75%乙醇或2‰新潔爾滅溶液擦拭機臺、桌面、門窗、墻壁等，用3%～5%的來蘇兒對地面擦拭消毒。每3天生產結束后，用75%乙醇或2‰新潔爾滅溶液對潔凈室內所有設施表面及頂棚、照明等表面進行擦拭消毒， 3%～5%的來蘇兒對地面進行消毒，目的是殺死因生產過程中產生的細菌繁殖體，控制潔凈室內微生物含量。這些措施僅能控制潔凈室內空氣中的細菌量及雜菌種類，如果霉菌較多，就要先用5%石碳酸全面噴灑室內，然后用甲醛熏蒸才能達到無菌效果，而且只有這樣才能殺死細菌、雜菌芽孢。每個生產周期結束，下個周期生產前對有無菌要求的潔凈室先進行消毒液消毒，檢測潔凈室內塵埃粒子數符合規定后，再對潔凈室內進行甲醛氣體熏蒸，從長期檢測的結果來看，這種環境滅菌方法效果很好。
Control of microbial content. Control of microbial content in the clean room environment is still a good air purification system facilities, and its filtering efficiency can reach 99.9% ~ 99.99% to filter out bacteria and dust in the air. Production in clean indoor temperature strictly control in the 18 to 26 degrees, relative humidity control at 45% ~ 65%, to destroy is conducive to bacterial growth conditions, coupled with disinfection liquid cleaning and disinfection, environmental control effect is satisfaction. About daily disinfection, after the end of the daily production, with 75% ethanol or 2 per thousand new clean Er destroy solution cleaning machine, desktop, doors, windows, walls, with 3% ~ 5% to su er on the ground to wipe disinfection. Every 3 days after the end of the production, with 75% ethanol or 2 per thousand new clean Er de solution on the surface of the clean room facilities in all surface and ceiling, lighting and other to wipe disinfection, 3% ~ 5% to su er on the ground for disinfection to kill the bacteria as a result of the production process of propagules, control the clean indoor microbial content. These measures can only control the amount of bacteria in clean indoor air and mixed bacteria, if more mold, it is necessary to first with 5% carbolic comprehensive indoor spraying and formaldehyde fumigation to reach the sterile effect, and the only way to kill bacteria, Bacillus bacteria. After the end of each production cycle, before the next cycle production of sterile clean room disinfection, detection clean indoor dust particle number in accordance with the provisions, the clean room were formaldehyde fumigation, from the point of view of the detection of long-term results, result of sterilization method of this kind of environment very good.
甲醛氣體滅菌技術。甲醛熏蒸不僅對不易殺死的霉菌有很好的滅菌效果，而且對環境中的細菌芽孢殺滅效果較好。潔凈廠房設計施工 http://www.jnjkjh.com/ 甲醛熏蒸操作需要注意：首先保證室溫達到35℃以上、相對濕度在60%以上；其次要保證甲醛用量達到房間體積10克/立方米的比例；另外，房間消毒時間不少于12小時；特別值得提醒的是在甲醛置換前用同比例的氨水進行中和，這樣將最大限度地減少對人體的危害以及對環境的污染。為了防止細菌對甲醛產生耐藥性，可以用臭氧進行交替效果會更好。
Formaldehyde gas sterilization technology. Formaldehyde fumigation not only for the non - easy to kill the mold has a very good sterilization effect, but also on the environment of bacterial spores to kill the effect is better. Clean plant design and construction of formaldehyde fumigation operation need to pay attention to: first, ensure room temperature reaches 35 degrees above, relative humidity above 60%; secondly, to ensure that the amount of formaldehyde reached the room volume 10 grams / cubic meters of proportion; in addition, room disinfection time not less than 12 hours; worth to remind is in formaldehyde before replacement with the same proportion of the ammonia neutralization, which will maximize the reduce the harm to the human body and the environmental pollution. In order to prevent the bacteria to produce drug resistance, ozone can be used for alternating effect will be better.
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