To carry out sterility inspection and microbial limit inspection, firstly, according to the requirements of the "Quality Management Regulations of the Laboratory of Drug Inspection Institute" and the "Good Manufacturing Practices for Pharmaceutical Products", establish a sterile room with reasonable layout, convenient use and safe operation. It is equipped with complete experimental facilities and management system. Sterility examination, microbial limit examination, and inoculation room (inoculation of control bacteria, strain passage) should be strictly separated. Laboratories with dangerous strains and toxins such as Clostridium tetani and aflatoxin should be used separately to control Prevent spread.
1, the layout of the sterile room
1 According to the sample inspection requirements, generally should include at least the dressing buffer system, the microbial limit examination room, the sterility examination room, the positive bacteria chamber and the logistics channel.
2 The dressing system should include at least one (including more shoes), two more (including hand washing), cushioning, and pedestrian flow corridors.
3 The logistics channel should consider the layout of the net pollution diversion, and the conditional can set the dirt corridor.
2, the design requirements of the sterile room
1 Purification level: clean corridor, examination room, positive bacteria room should be 10,000 grades; other rooms should be 100,000 grades.
2 Airflow organization: The positive bacteria chamber is negatively pressed to the corridor, the corridor has a positive pressure of 5Pa for buffering; the positive bacteria chamber is completely exhausted.
3Electrical control: control switch external; set communication system.
3. Structure and requirements
Sterile clean room should not be located on the bottom layer, moisture-proof, mildew-proof, good lighting, away from traffic trunks, toilets and contaminated areas, the area does not exceed 10m2, the height does not exceed 2.4m, consists of two buffer rooms and operation rooms. There should be a sample transfer window between the buffer rooms in the operation room, and the doors entering and exiting the operation room and the buffer room should not be directly opposite. The sterile room should be smooth and flat on all sides, no gaps, no dust, no dust, corrosion resistance, easy to clean. The connection between the wall and the ground, the wall and the ceiling should be concave and curved, and the sewer should not be installed in the operation room.
The lighting in the sterile room should be embedded in the ceiling, the lighting area should be large, the light should be evenly distributed, and the illuminance should be no less than 300 lux. The buffer room and the operation room should be equipped with ultraviolet germicidal lamps (2-25w/m3)' for air disinfection. Ultraviolet wavelengths of 200-300nm have a bactericidal effect, of which 265-266nm has the strongest bactericidal effect, which is consistent with the absorption spectrum of DNA. The bactericidal mechanism may be caused by the formation of thymine dimer in bacterial cell DNA, thereby interfering with bacteria. Cellular DNA replicates, causing bacterial variability to die. Ultraviolet germicidal lamp has the best sterilization effect within 1m distance, and the illumination time is 30min each time. The radiation intensity of the UV lamp should be checked regularly, and should not be less than 70μW·cm-21m. The disadvantage is that the penetrating power is weak. A piece of cardboard can block the transmission of light and cannot penetrate the solid matter, so it can only be used for surface disinfection and disinfection of some heat-resistant or chemical disinfectant articles.
4, temperature, humidity
The sterile indoor temperature and relative humidity directly affect the sterilization effect of the ultraviolet germicidal lamp, so the temperature is preferably controlled at 25±2°C and the relative humidity is 40-60%. The clean air of the operating room or the clean bench should be kept at a positive pressure to the environment, not less than 49Pa.
5, the operation room
An air sterilization filter laminar flow device and a temperature control device should be installed in the sterile room. Cleanliness requirements: Clean bench cleanliness is 100, and sterile rooms should be 10,000.
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