What Are The Contamination And Common Sterilization Methods Used in Cleanrooms

As a critical environment in the medical and pharmaceutical industries, the cleanliness of cleanrooms is directly related to product quality and safety. However, the greatest source of contamination in Cleanrooms often comes from the users themselves, especially microorganisms shed from the skin. These microorganisms can be spread through the airflow and pose a threat to the clean environment. Therefore, controlling microbial contamination and taking effective disinfection measures are the core tasks of cleanroom management.

What to look for keeping the Cleanroom clean?

1. Inner surfaces of the cleanroom and its internal equipment

In order to comply with GMP and achieve cleanliness specifications, all surfaces of the cleanroom should be smooth and impermeable and not produce their own contamination, i.e., not produce dust, or falling debris, corrosion-resistant, easy to clean, or else provide a place for microorganisms to multiply, and the surfaces should be rugged and not cracked, broken or dented.

In accordance with the requirements of cleanrooms at all levels of regular cleaning and disinfection, the frequency can be every operation after use, many times a day, every day, every few days, once a week, etc. for cleaning and disinfection. It is recommended to clean and disinfect the operating surface after each operation, disinfect the floor every day, the wall every week, and the space every month, and strictly clean and disinfect the operation according to the cleanroom level and the set standard specification, and make a good registration record.

2. Control of air in the Clean Room

The Clean Room needs regular maintenance and good daily monitoring. Special attention should be paid to the monitoring of bacterial plankton in the pharmaceutical clean room, the bacterial plankton in the space with the bacterial plankton sampler to extract a certain volume of air in the space, the air flow through the filling of a specific culture medium contact dish, the contact dish will capture microorganisms, and then will be placed in the dish into the incubator culture and counting the number of colonies, calculated the number of microorganisms in the space. The microorganisms in the laminar flow layer also need to be detected, with the corresponding laminar flow layer plankton sampler, the working principle is similar to the space sampling, but the sampling point should be put into the laminar flow layer.

If compressed air is used in the sterile room, microbial detection of compressed air is also required, using the corresponding compressed air tester, the air pressure of the compressed air needs to be adjusted to the appropriate range to prevent microorganisms and culture medium from being destroyed.

3. Commonly used disinfection methods in cleanrooms

1. Ultraviolet lamp disinfection sterilization

2. Ozone sterilization

3. Gas sterilization disinfectant solution has formaldehyde, epoxy hashane, peroxyacetic acid, carbolic acid and lactic acid mixture, etc. Common disinfectants are isopropyl alcohol (75%), ethanol (75%), garrison aldehyde, jerricans and so on. Sterilizers used in the sterile room must be sterilized and filtered through a 0.22 μm membrane in a biological safety cabinet.

Therefore, the contamination control of cleanrooms needs to start from various aspects such as surface cleaning, air monitoring and disinfection methods. Through regular cleaning, strict monitoring and scientific selection of disinfection methods, microbial contamination can be effectively reduced to ensure that the cleanroom environment complies with GMP standards and other relevant norms. Only by continuously focusing on cleanroom cleaning and disinfection can we provide the medical and pharmaceutical industries with a safe and reliable production environment that safeguards product quality and patient safety.