控制洁净厂房设计施工的微生物环境
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- 发布日期：2017-04-13 16:21:36
洁净厂房设计施工分为生物洁净室和非生物洁净室两种。生物洁净室空气净化系统必须连续运转；非生物洁净室使用前空气净化系统应提前4小时开启。检测尘埃粒子用尘埃粒子计数器，在环境卫生清洁后缓冲0.5～1小时之后进行，为避免人为造成的污染，静态测试时洁净室内仅限两人。注射剂的生产过程中应对关键控制点进行动态监控。
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。控制洁净室环境中的微生物含量仍然是靠良好的空气净化系统设施，其过滤效率可以达到99.9%～99.99%地滤除空气中的细菌和尘埃。生产中洁净室内温度严格控制在18～26℃、相对湿度控制在45%～65%，以破坏有利于细菌的生长条件，加之消毒液的清洁消毒，环境控制效果令人满意。关于日常消毒液消毒，每天生产结束后，用75%乙醇或2‰新洁尔灭溶液擦拭机台、桌面、门窗、墙壁等，用3%～5%的来苏儿对地面擦拭消毒。每3天生产结束后，用75%乙醇或2‰新洁尔灭溶液对洁净室内所有设施表面及顶棚、照明等表面进行擦拭消毒， 3%～5%的来苏儿对地面进行消毒，目的是杀死因生产过程中产生的细菌繁殖体，控制洁净室内微生物含量。这些措施仅能控制洁净室内空气中的细菌量及杂菌种类，如果霉菌较多，就要先用5%石碳酸全面喷洒室内，然后用甲醛熏蒸才能达到无菌效果，而且只有这样才能杀死细菌、杂菌芽孢。每个生产周期结束，下个周期生产前对有无菌要求的洁净室先进行消毒液消毒，检测洁净室内尘埃粒子数符合规定后，再对洁净室内进行甲醛气体熏蒸，从长期检测的结果来看，这种环境灭菌方法效果很好。
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.
甲醛气体灭菌技术。甲醛熏蒸不仅对不易杀死的霉菌有很好的灭菌效果，而且对环境中的细菌芽孢杀灭效果较好。洁净厂房设计施工 http://www.jnjkjh.com/ 甲醛熏蒸操作需要注意：首先保证室温达到35℃以上、相对湿度在60%以上；其次要保证甲醛用量达到房间体积10克/立方米的比例；另外，房间消毒时间不少于12小时；特别值得提醒的是在甲醛置换前用同比例的氨水进行中和，这样将最大限度地减少对人体的危害以及对环境的污染。为了防止细菌对甲醛产生耐药性，可以用臭氧进行交替效果会更好。
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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