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Rules for the construction and use of sterile air filtration facilities

Rules for the construction and use of sterile air filtration facilities

Rules for the construction and use of sterile air filtration facilities

2023-02-16

Rules for the construction and use of sterile air filtration facilities

Construction rules

1、Aseptic room should have two different parts, an operation room, and a buffer room, the cleanliness of the operation room should reach 10000 level, the temperature should be kept between 20--24℃, and the humidity should be maintained between 45--60%;

2、The aseptic room should be kept clean, it is strictly forbidden to pile up all kinds of miscellaneous things;

3. Proper management measures should be taken to prevent the contamination of sterilization equipment and culture media, and if the facilities are contaminated, they should be stopped immediately;

4. The room should be equipped with the appropriate concentration of the disinfectant solution, such as 5% cresol solution, 70% alcohol, 0.1% methadone solution, etc;

5. Special disinfectant solutions should be used regularly to sterilize and clean the indoor environment to ensure that its cleanliness is always in line with production requirements;

6, part of the need to bring into the sterile room to use instruments, etc. should be tightly wrapped and sterilized before bringing them in;

7, staff must wash their hands with disinfectant before entering the aseptic room, then change the special work clothes, shoes, and hats in the buffer room, etc., all the preparations are completed before entering the aseptic room;

8. Before use, the UV lamp in the sterile room must be opened for irradiation sterilization for about 30 minutes or more, while the ultra-clean table is opened for blowing; wait until the corresponding work is completed to clean up the indoor environment in time, and then use the UV lamp for irradiation sterilization for about 20 minutes.

Cautions

1. The various accessories used in the sterile room should be kept intact in their outer packaging before installation and should not be opened at will to prevent any kind of contamination;

2. A negative control should be done during each operation to check the reliability of the operation;

3. When using the bacterial solution, the aspirator must be used for aspiration, not directly touching the pipette;

4. Some pipettes and test tubes with a bacterial solution should be soaked in a special disinfection bucket after use for about 24 hours;

5. If you spill any bacterial solution on the table or floor, you should dispose of it promptly and specifically;

6. All items with live bacteria must be strictly disinfected before being rinsed under the tap to avoid contamination of the drain;

7. The bacteria count in the room should be checked regularly every month, and the process is very simple. If any of these are exceeded, the sterile room should be thoroughly disinfected until it meets the requirements.