[Original] Analysis of Environmental Disinfection Method in Clean Room-Workshop (Production Department)



Summary: At present, formaldehyde steam fumigation is mostly used for environmental disinfection of clean rooms in our country to achieve the effect of killing microorganisms. This method has good disinfection and sterilization effect and can kill most kinds of microorganisms, but it has great irritation to human body and residue problems, which makes users have headaches, with the development of modern technology and reference to foreign products, we can now find more suitable items to replace them to solve the harm to human body caused by environmental disinfection and sterilization.

Key Words: Clean Room Disinfection and Sterilization Solution Harms Human Body

1. Formaldehyde Steam Sterilization Effect and Harm: In order to meet the requirements of relative aseptic environment in most sanitary clean rooms, especially pharmaceutical factories, formaldehyde fumigation steam is mostly introduced into the clean room through purification air conditioner, and then the air conditioner is turned off to keep formaldehyde gas in the room for about 6 hours. Disinfection after disinfection and sterilization, after the air is exhausted, ammonia fumigation steam is introduced into the clean room according to the proportion for neutralization, and finally the air is exhausted. This method generally takes 2 days according to the procedure, and the environment can be detected on the 3rd day. The main method is to collect biological ions in the air in a petri dish through the principle of natural deposition of indoor dust particles, and to evaluate the cleanliness of the clean room by breeding the number of colonies in the courseware under adaptive conditions for a certain period of time.

Formaldehyde can inactivate microorganisms by more than 95%, and there are basically no living microorganisms in the Petri dishes. For many years, clean rooms of pharmaceutical factories have been relying on this method. Many enterprises often find that the equipment and most white powder covered on the ground surface after ammonia neutralization are mainly neutralized products. For pharmaceutical clean rooms, especially high-risk products such as injections, secondary pollution requires enterprises to do a lot of work to eliminate, this method should no longer be widely used today when the new version of GMP requires as much as possible to reduce pollution sources.

Formaldehyde is a colorless, strong pungent odor of aqueous solution, China's toxic chemicals priority control list of formaldehyde in the second place, has been listed as carcinogenic and teratogenic substances by WHO, is recognized as the source of allergic reactions, but also one of the potential strong mutagens. The effects on human health are manifested in the aspects of abnormal smell, irritation, allergy, abnormal lung function, abnormal liver function and immune function. For the employees of pharmaceutical enterprises who operate this method, the amount of inhalation at one time is very large. Although there is a protective cover, it cannot completely prevent inhalation. The cleanliness after disinfection and sterilization has different degrees of pungent odor in the first few days, and some people will feel uncomfortable or dizzy, spicy eyes and other bad feelings.

2. Disinfectant and Disinfection and Sterilization Method for Replacing Formaldehyde: Glutaraldehyde, peracetic acid, hydrogen peroxide, etc. are commonly used as disinfectant for clean environment space in the market. Glutaraldehyde is mainly sprayed by atomizer in the area to be disinfected to achieve the disinfection effect. After repeated use, the disinfection effect is general, more yellow residues are easily produced, and it is also irritating to people. Peracetic acid is heated and evaporated in an alcohol furnace to evaporate the solution into the air to achieve the disinfection effect. This method has higher operation requirements for the operator and strict ratio requirements. The solution splashed into the skin or eyes is easy to burn and cause damage. The secondary pollution caused by combustion makes pharmaceutical enterprises use this method less and less. Hydrogen peroxide is a disinfectant with strong disinfection and sterilization ability, and its biggest advantage is that there is no residue, it mainly uses a sprayer to atomize the solution to diffuse the space to achieve the disinfection effect. After verification, the disinfection effect is relatively ideal, the relative side effects are also small, and the disadvantage of strong corrosiveness to metals and the like is particularly obvious. Some enterprises have overcome this problem after special technical treatment of hydrogen peroxide disinfectant, and optimize it to be non-toxic and harmless. The automatic spraying device has even improved the disinfection method by one order.