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1. Cleanrooms (sterile rooms) must meet the requirements of the regulations
The sterile room should have good lighting, avoid moisture, and be far away from toilets and contaminated areas. The area is generally not more than 10m2, not less than 5m2, and the height is not more than 2.4m. It consists of 1-2 buffer rooms and operating rooms (the doors of the operating room and the buffer room should not be directly opposite), and there should be a sample transfer box with sterilization function between the operating room and the buffer room.
There should be a wash basin, towel, sterile clothes and pants rack and hooks, slippers, etc. in the buffer, and incubators and other sundries should not be placed; the sterile room should be smooth and flat on all six sides and can withstand cleaning and disinfection. The connection between the wall and the ground and the ceiling should be concave arc, without gaps and dead corners. Sewers should not be installed in the operating room.
The clean room operating room should have a one-way air flow device with air sterilization and filtration, the operating area should have a cleanliness level of 100 or a Clean bench of the same level, the indoor temperature should be controlled at 18-26℃, and the Relative humidity should be 45%-65%.
(Figure 1: GMP Clean room)
Ultraviolet lamps or other suitable disinfection devices that can achieve air disinfection effects should be installed in the buffer and operating room. The static pressure difference between adjacent rooms with different air cleanliness levels should be greater than 5Pa, and the static pressure difference between the clean room (area) and the outdoor atmosphere should be greater than 10Pa. The lighting in the sterile room should be embedded in the ceiling, and the indoor light should be evenly distributed, with an illumination of not less than 300lx.
The ultraviolet germicidal lamps (2-2.5w/m3) installed in the buffer room and the operating room should be regularly checked for radiation intensity, and the requirement is to reach 40uw/m2 on the operating surface. Ultraviolet germicidal lamps that do not meet the requirements should be replaced in time.
2. Establish A Clean Room use registration system
The following items can be set in the register: such as use date, time, user, equipment operation status, temperature, humidity, cleanliness status (settled bacteria count, floating bacteria count, dust particle count), repair reason, repair result, cleaning work (countertop, floor, surface, ceiling, transfer window, door handle), disinfectant name, etc.
3. Establish a standard operating procedure (SOP) for the use of clean rooms and strictly manage it
The content should at least include the following points:
(1) Specify the operating time of the purification system. Before each experiment, the purification system should be turned on for at least 1 hour, and the purification table and ultraviolet lamp should be turned on at the same time.
(2) Basic requirements for items entering the clean room (sterile room): All items entering the clean room (sterile room) must first be disinfected and sterilized with disinfectants on the external surface in the first buffer room, and then sent to the sterile room after passing through the logistics buffer room and transfer window for more than 1 hour and sterile air blowing. Note that fiber-bearing and dust-prone items must not be brought into the clean room. Fixed items in the sterile room must not be moved out at will.
(Figure 2: Clean room operation)
(3) Requirements for personnel entering the clean room (sterile room): Experimental personnel must not wear makeup, watches, rings or other jewelry when entering the clean room (sterile room); they must not eat or chew gum.
After cleaning hands, you should enter the first buffer room to change clothes, put on disinfected isolation slippers, take off your outer clothes, disinfect your hands with disinfectant, put on sterile gloves, put on a sterile hood (do not let your hair, clothes, etc. be exposed), and put on a sterile mask.
Then, change or put on a second pair of sterile gloves, and change to a second pair of disinfected isolation slippers when entering the second buffer room. After a 30-second air shower in the air shower, enter the sterile room.
(4) Requirements for observation of clean room temperature and humidity: Observe whether the temperature and humidity displayed on the thermometer and hygrometer in the room are within the specified range, and record them as the original data of the experiment. If any problems are found, the cause should be found in time, repaired in time and reported to the laboratory supervisor in time, and the cause and result of the repair should be recorded and filed.
(5) Requirements for sedimentation colony count and floating bacteria determination: At the same time as each experiment, microbial sedimentation colony counts should be performed on the operating room and laminar flow table, and the results should be recorded in the usage registration book and recorded in the experimental report as the original data of the experimental environment. Once a week, or when necessary for sterility inspection, the floating bacteria in the operating room and clean bench are measured at the same time during each experiment, and the results are recorded in the usage registration book and recorded as the original data of the experimental environment in the experimental report.
(6) Clean room disinfection requirements: The sterile room should be cleaned with 0.1% chlorhexidine or 2% cresol wave or other suitable disinfectants every week and before each operation (common disinfectants include: 5-20 times diluted iodine tincture solution, 0.1% chlorhexidine solution, 1:50 84 disinfectant, 75% ethanol solution, 3% iodine solution, 5% carbolic acid disinfectant, 2% glutaraldehyde aqueous solution, paraben ethanol disinfectant (prescription: methyl parahydroxybenzoate 21.5g; propyl parahydroxybenzoate 8.6g, 75% ethanol 10m), etc.
(Figure 3: Clean room disinfection)
The types of disinfectants used and their use must be verified for effectiveness before use, and the types of disinfectants should be changed regularly) to wipe the operating table and dead corners that may be contaminated. The method is to use sterile gauze soaked in disinfectant solution to clean the entire inner surface and top surface of the clean bench, as well as the sterile room, personnel flow, logistics, and the floor, transfer window, and door handles in the middle.
The cleaning and disinfection procedure should be from the inside to the outside, from the high clean area to the low clean area. Gradually exit the clean area. Then turn on the sterile Air Filter and UV light for 1-2 hours to kill the remaining microorganisms. After each operation, wipe the work surface with the above disinfectant solution, remove the indoor moisture, and sterilize with UV light for 30 minutes.
(7) Other requirements: In case of power outage, stop the experiment immediately and leave the sterile room. Turn off all switches. Turn on the machine room for at least 1 hour before re-entering the sterile room. Clean room (sterile room) is an important place and the most basic facility for microbial testing. It is an important material basis for the quality assurance of microbial testing.
Therefore, its design should be carried out in accordance with the national standard "Clean Factory Design Specifications" and Article 18 of the "Laboratory Quality Management Specifications for Drug Inspection Institutes (Trial)" issued by the State Food and Drug Administration.
The construction, installation and acceptance of the clean room of the microbiological laboratory should be carried out in accordance with the national industry standard "Construction and Acceptance Specifications for Clean Rooms". For microbial testing workers and users, a larger amount of work is to carry out normal management and daily use. The standards of clean rooms (sterile rooms) must meet the GMP cleanliness standards.
