Clean room (aseptic room) is an important place and the most basic facility for microbial testing. It is an important material basis for quality assurance of microbial detection. For microbiological detection workers and clean room use managers, a greater amount of work is to carry out normal management to daily use. The standard of clean room (aseptic room) should meet the requirements of GMP cleanliness standard. The use and management of clean room (aseptic room) should do the following:

1. Clean room (aseptic room) should meet the standard requirements: 

The aseptic room should have good lighting, avoid moisture and stay away from contaminated areas. The area is generally not more than 10㎡, not less than 5㎡and the height shall not exceed 2.4m. It is composed of 1-2 buffer rooms and operation rooms (The doors of the operation room and buffer room should not be directly opposite); Transfer window with sterilizing function between handling room and buffer room. In the buffer room, there should be a wash sink, sterile clothes, slippers and wardrobe, etc., there should not be other debris placed. The wall of the sterile room should be smooth and smooth, and can withstand cleaning and disinfection. The connection between the wall and the floor and the ceiling should be in a concave arc shape, without gaps, leaving no dead corners. The aseptic operation room should have a unidirectional air device for air sterilization filtration, a super-clean workbench with a cleanliness of 100 or the same level, indoor temperature control of 18-26 ℃, and relative humidity of 45%-65%. The buffer room and the operating room should be equipped with UV lamps or other appropriate disinfection devices that can achieve the effect of air disinfection. 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 aseptic room should be embedded in the ceiling, the indoor light should be evenly distributed, and the illuminance is not less than 300lx.

2. Establish the use of standard operating specifications (SOP) and strict management:

(1)Items entering the clean room (aseptic room) basic requirements: All items entering the clean room (aseptic room) must be sterilized with disinfectant on the external surface in the first buffer room, and then sent to the aseptic room through the logistics buffer room, transfer window for more than 1 hour, and sterile air drying. Sterile indoor fixed items shall not be arbitrarily brought out.

(2) Personnel entering the clean room (aseptic room) requirements: experimental personnel entering the clean room (aseptic room) shall not make up, wear watches, rings and other jewelry. After cleaning your hands, you should enter the first buffer room and change your clothes. At the same time, you should change your disinfecting slippers, take off your coat, disinfect your hands with disinfectant, put on sterile gloves, change your sterile hoodie (do not expose your hair, clothes, etc.), and put on a sterile mask. Then put on a second pair of sterile gloves, and change a second pair of disinfectant isolation slippers when entering the second buffer room. Then through the air shower room 30s air shower into the sterile room.

(3) Temperature and humidity observation requirements: Observe whether the temperature and humidity displayed on the thermometer and hygrometer are within the specified range.

(4) Settling colony count and plankton determination requirements: at the same time of each experiment, count the settling colony of microorganisms in the operating room and laminar flow table, record the results in the user log, and record the original data of the experimental environment in the experiment report.

(5) Disinfection requirements: Every week and every operation in the sterile room, the operating table and the dead corners should be wiped with appropriate disinfectant. The specific method is to use sterile gauze impregnation disinfection solution to clean the entire inner surface of the super clean bench, and aseptic room, flow of people, logistics, buffer room floor, transfer window, door handle. Cleaning and disinfection procedures should be from the inside out, from high clean areas to low clean areas. Gradually exit the clean area. Then turn on the aseptic air filter and UV lamp for 1-2h sterilization to kill the remaining microorganisms. At the end of each operation, wipe the workbench with the above disinfection solution, remove indoor moisture, and sterilize with UV lamp for 30min.

(6) Other requirements: In case of power failure, stop the experiment immediately and leave the aseptic room. Turn off all the switches. Open the machine room for at least 1h before re-entering the aseptic room.

3. Requirements and methods of cleanliness inspection: 

The number of colonies in the air should be checked after disinfection, before sterile test and during operation to determine whether the aseptic room reaches the specified cleanliness, and there are often settling bacteria and floating bacteria determination methods.

4. Regular revalidation of cleanliness: 

Periodically (every quarter, half a year, one year) or when there is a major change in the clean room facilities, the cleanliness should be re-verified according to the national standard to ensure that the cleanliness meets the requirements, and the original verification records are kept and archived regularly. The verification results were recorded in the aseptic room use register as the original basis of the experimental environment and trend analysis data.

5. Regular replacement of new UV lamps, replacement of the purification system of the initial effect, medium effect, high efficiency head: regular (at least once a year) replacement of new UV lamps to ensure that UV lamp sterilization continues to be effective. At least once every 2 years, or according to the cleanliness to verify the actual situation, regularly replace the initial effect, medium effect, high efficiency head. To ensure that the function of the purification system continues to be effective, and at the same time, make a replacement record in the use of the log, and regularly archive and save.

6. During use, the movement or activity of personnel should be reduced as much as possible: 

Usually, the movement or activity of personnel should be reduced as much as possible in the laboratory, and the door of the clean room should be closed or automatic door closers should be installed to keep it closed.

7. Stop use immediately when the cleanliness does not meet the requirements: 

When the cleanliness does not meet the requirements, it should be stopped immediately, find the cause, thoroughly clean, must be verified by the cleanliness and meet the requirements, and then use again, and record the situation in the aseptic room use register, regular archival storage.

8. Guidance and supervision of incoming foreign personnel or maintenance personnel: 

non-microbial room inspection personnel shall not enter the clean room (aseptic room), and foreign personnel or maintenance personnel who must enter shall be guided and supervised.

9. Clean room (aseptic room) daily management: 

establish a safety and health duty system, once found ventilation system, walls, ceilings, floors, doors, windows and public media systems and other facilities have damage, to report in time and take appropriate repair measures, and keep records in a timely manner.

Suzhou Pharma Machinery Co.,Ltd.

2023/12/11

Tia