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Three Precautions For Keeping Clean Room

Three Precautions For Keeping Clean Room

2022-04-12

In the medical and pharmaceutical industries, the control of microorganisms is very important, especially those that may fall off from the skin and deposit into the airflow.The study of clean room microbiota is important for microbiologists and quality controllers to assess the changing trends, especially for the screening of drug-resistant strains and cleaning and disinfection methods.

 

1. Internal surface and internal equipment of the clean room

 

The principle is that the selection of materials is important, and the daily cleaning and disinfection is more important.In order to comply with GMP and achieve cleanliness specifications, all surfaces of the clean room should be smooth and airtight, and do not produce their own pollution, that is, no dust, or dust, corrosion resistance, easy to clean, otherwise it will provide a place for microbial reproduction, the surface should be strong and durable, can not crack, broken or depression.There are many options available for cleanroom materials.Regular cleaning and disinfection according to the requirements of each level of cleaning room, the frequency can be multiple times a day, once a day, once a few days, and once a week.It is recommended that the operation table should be cleaned and disinfected after each operation, the floor should be disinfected every day, the wall is weekly and the space every month, strictly cleaned and disinfected according to the clean room grade and the set standards and specifications, and records should be made.

 

2. Control of clean indoor air

 

In general, we should choose the appropriate clean room design, regular maintenance, and daily monitoring and management.Special attention should be paid to the pharmaceutical clean room planktonic bacteria in the space with planktonic bacteria sampler to extract a certain volume of air in the space, airflow through the filling of a specific medium contact plate, contact plate will capture microorganisms, after the plate into the incubator culture count colonies, calculate the number of microorganisms in the space.Microorganisms in the laminar layer also need to be detected, with the corresponding laminar spheric planktonic bacteria sampler, which works similar to spatial sampling, but the sampling point should be placed in the laminar layer.If compressed gas is needed in the sterile room, it also needs to be detected on compressed air. With the corresponding compressed air detector, the air pressure of compressed gas should be adjusted to the appropriate range to prevent the destruction of microorganisms and culture medium.

 

3. Requirements for the personnel in the clean room

 

Clean room working personnel should receive regular training in pollution control theory.They go in and out of the clean room through air locks, air shower and dressing rooms, and they must wear specially designed clothes covering the pollutants naturally produced by the skin and body.

Based on the classification and function of the clean room, the staff may simply protect the experimental suit and headgear, or completely wrap it without exposing any skin.

Clean clothing is used to prevent particles and or microbes released from the wearer's body and contaminating the environment.The clean suit itself does not release particles or fibers.This type of personnel contamination can be reduced, applicable in the semiconductor and pharmaceutical industries, and it can prevent cross-infection between medical personnel and the patient in the healthcare industry.

Clean protective equipment includes protective clothing, boots, shoes, aprons, beard covers, round hats, masks, tooling / lab suits, robes, gloves and finger covers, sleeves and shoes, boot covers.The type of clean clothing used shall reflect the clean room and product category.Low grade cleanrooms may require special shoes with completely smooth soles and do not stand with dust or dirt.

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Suzhou Pharma Machinery Co.,Ltd.

2022/04/12

Alice




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