The company is engaged in clean rooms and sterile rooms(Including clean and sterile rooms, as well as various sterile rooms ranging from one hundred to three hundred thousand levelsA comprehensive large-scale enterprise that integrates planning and design, various air purification equipment, purification plants, production design and decoration of air filters, as well as research, development, design and production of laboratory basic equipment. It is a professional in the South China regionOne of the companies.

sterile roomUsually located in an area within a microbiology laboratory. The area should not be too large, about 15-20 square meters is sufficient, with a height of about 2.5 meters. A buffer room needs to be set up outside the sterile room, and the doors of the buffer room and the sterile room should not face in the same direction to prevent air flow from bringing in miscellaneous bacteria. The sterile room and buffer room must be sealed. Indoor ventilation equipment must have air purification and filtration devices. The conventional design and production of sterile rooms should be equipped with sterile operating rooms and buffer rooms. The cleanliness of sterile operating rooms is generally level 10000, and local cleanliness is level 100 (usually controlled by ultra clean workbenches). The indoor temperature should be maintained at 20-24 ℃, and the humidity should be maintained at 45-65%. The cleanliness of the ultra clean workbench should reach level 100.

Aseptic rooms are often used in microbiology laboratories. Generally, sterile laboratories use ultra clean tables for operational experiments. The main function of the ultra clean table is to use an air laminar flow device to remove various small dust, including microorganisms, from the upper part of the workbench. By using an electric device to pass air through a high-efficiency filter and enter the workbench, the workbench is always kept under the control of flowing sterile air. And there is a high-speed air curtain on the side close to the outside to prevent external contaminated air from entering. If there is an odor or unsafe gas generated during the experiment, it is necessary to set up a fume hood or biosafety cabinet to ensure safety. Please refer to:

The floor and walls in the sterile room must be flat, not prone to dirt and grime, and easy to clean. The tabletop of the workbench should be in a horizontal position. Both the sterile room and the buffer room are equipped with ultraviolet lamps, and the ultraviolet lamps in the sterile room are 1 meter away from the workbench. Staff entering the sterile room should wear sterilized clothing and hats. The conventional classification of sterile rooms: 1. Secondary and tertiary sterile rooms comply with the health industry standard of the People's Republic of China: WS233-2002 "General Guidelines for Biosafety in Microbiology and Biomedical Laboratories".

Aseptic room classification:

1. The Level 2 (P2) sterile room is classified as Class 10000 and Class 100 locally, in compliance with the currently recognized US Federal 209E standard. The secondary sterile room includes high, medium, and primary filtration systems, a small central air conditioning system, laminar air supply, and well return air. The changing room and air shower room are equipped with a human body automatic sensing system.

2. The technical indicators of each system are as follows: the wind speed of the air supply outlet in the changing room and operating room is ≥ 0.3 meters/second, the wind speed in the air shower room is ≥ 15 meters/second, the static pressure difference between the operating room and the environment is ≥ 5Pa, and the system noise is ≤ 60dB

In addition to the characteristics of a Level 2 sterile room, a Level 3 (P3) sterile laboratory is also equipped with electronic interlocking doors, transmission window door interlocks, epoxy resin self leveling floors, and sewage disinfection facilities. Configure a secondary biosafety cabinet, with negative pressure spaces in both the laboratory and buffer room. The relative pressure in the experimental room ranges from -30Pa to -40Pa, while the relative pressure in the buffer room ranges from -15Pa to -20Pa.

Aseptic room structure:
Firstly, the main structure
The main body consists of color steel plates and aluminum alloy profiles.
All indoor corners, both inside and outside, are made of 50 round aluminum alloy to solve problems such as easy pollution, dust accumulation, and difficulty in cleaning. The structure is sturdy, the lines are concise, the appearance is elegant, and the sealing is good.

Secondly, purify the air conditioning system
According to different actual situations of customers, different air conditioning systems are adopted. Overall, it can be divided into two types: one is the FFU air supply system, which is characterized by uniform air supply and simple installation. The second is a centralized air supply system, which can effectively handle the air.

Thirdly, the lighting system
All use purification lamps that are easy to clean and disinfect.
Fourthly, disinfection:
There are ultraviolet lamps installed inside the room for disinfection purposes.
Fifth, the ground
It is recommended to use PVC roll flooring or self leveling flooring for the ground, which has good overall integrity. Easy to clean and corrosion-resistant. If conditions permit, terrazzo flooring can also be used, or large tiles (at least 800mm x 800mm) with joints less than 2mm.

Attention should be paid to:
1. The sterile room should be kept clean and debris should not be piled up to prevent contamination.

2. The sterile room should be regularly sterilized and cleaned with appropriate disinfectant to ensure that the cleanliness of the sterile room meets the requirements.

3. Strictly prevent contamination of all sterilization equipment and culture media, and those who have been contaminated should stop using them.

4. The sterile room should be equipped with disinfectant solutions of working concentration, such as 5% cresol solution, 70% alcohol, 0.1% chlorhexidine solution, etc.

5. All instruments, apparatus, petri dishes, and other items that need to be brought into the sterile room should be tightly wrapped and sterilized using appropriate methods.

Before entering the sterile room, staff must wash their hands with soap or disinfectant, and then change into specialized work clothes, shoes, hats, masks, and gloves in the buffer room (or wipe their hands again with 70% ethanol) before entering the sterile room for operation.

7. Before using the sterile room, the UV lamp must be turned on to irradiate and sterilize for more than 30 minutes, and at the same time, the ultra clean table must be turned on for blowing. After the operation is completed, the sterile room should be cleaned in a timely manner, and then sterilized by irradiation with ultraviolet light for 20 minutes.

Before inspection, the outer packaging of the test sample should be kept intact and not opened to prevent contamination. Before inspection, disinfect the outer surface with a 70% alcohol cotton ball.

During each operation, a negative control should be performed to check the reliability of aseptic procedures.

10. When suctioning bacterial liquid, it must be suctioned with an ear ball, and do not directly touch the straw with your mouth.

11. The inoculation needle must be sterilized by flame burning before and after each use, and the culture can only be inoculated after cooling.

12. Straws, test tubes, culture dishes, and other vessels containing bacterial liquid should be soaked in a disinfection bucket containing 5% Lysol solution for disinfection, and taken out and rinsed after 24 hours.

13. If bacterial liquid is spilled on the table or floor, it should be immediately overturned in the contaminated area with a 5% bicarbonate solution or 3% Lysol solution for at least 30 minutes before treatment. When work clothes and hats are contaminated with bacterial liquid, they should be immediately removed and washed after high-pressure steam sterilization.

14. All items containing live bacteria must be disinfected before being rinsed under the faucet, and it is strictly prohibited to contaminate the sewer.

15. The sterile room should check the bacterial count monthly. In the open state of the ultra clean workbench, take several sterile culture dishes with an inner diameter of 90mm, inject about 15ml of nutrient agar medium melted and cooled to about 45 ℃ for sterile operation, and let it solidify. Invert it in a 30-35 ℃ incubator for 48 hours to prove sterility. After confirming sterility, take 3-5 plates and place them in the left, middle, right and other positions of the working position. Open the cover and expose for 30 minutes, invert it in a 30-35 ℃ incubator for 48 hours, and take them out for inspection. The average number of miscellaneous bacteria on the flat plate of a 100 level clean room shall not exceed 1 colony, and the average number of bacteria in a 10000 level clean room shall not exceed 3 colonies. If the limit is exceeded, the sterile room should be thoroughly disinfected until repeated inspections meet the requirements.

The above content refers to
Refer to the "Chinese Drug Inspection Standard Operating Procedures" and "Drug Hygiene Inspection Methods" chapter (Aseptic Inspection Method) of the Chinese pharmaceutical industry standard YY/T0188.6-1995 "Drug Inspection Operating Procedures"

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