Although many companies in China use hydrogen peroxide to sanitize cleanrooms, many in the industry are sceptical about its effectiveness. This article summarizes the requirements of different domestic and foreign laws and regulations/guidelines for the concentration and conditions of hydrogen peroxide disinfection for your reference:
“Technical Specifications for Disinfection and Sterilization” GB 28232 – “Hydrogen peroxide generator anquan and hygiene standards”
Air disinfection: Hydrogen peroxide can obviously kill microorganisms in the air. Hydrogen peroxide with a concentration of 20 mg/m3 is used for 30 minutes, and the killing rate of natural bacteria can reach more than 90 points.
Surface disinfection: disinfection with hydrogen peroxide gas. Hydrogen peroxide can kill microorganisms that are contaminated on the surface of items, but the effect is slow. It generally requires 60mg/m3, 70 points of relative humidity, and 60 min ~ 120 min to achieve the disinfection effect.
Verification Guide
When sterilizing, close the corresponding fresh air inlet and return air discharge valves, so that the air in the entire sterilized clean area circulates through the air duct of the purification system, and the hydrogen peroxide generator starts to work. If air disinfection is done every day, it can generally be started for 1 to 1.5 hours; if the surface, walls, floors, and equipment are disinfected by fumigation with hydrogen peroxide instead of chemical reagents every week, it can generally be started for 2 to 2.5 hours.
For planktonic bacteria in the air, the concentration of hydrogen peroxide sterilization is (2 ~ 4) 10-6; the sedimentation bacteria on the surface of the object is (10 ~ 15) 10-6
Design and apply hydrogen peroxide to sterilize for 60 minutes, and then keep it for a period of time (1 ~ 1.5 h) to kill bacteria deposited on the surface of machinery, equipment and buildings.
Principles of PDA TR 70 aseptic production equipment cleaning and disinfection program
Another way to treat small-scale or large-scale operations with gas is to use hydrogen peroxide. Hydrogen peroxide is produced by increasing the voltage with oxygen. The system uses high-concentration hydrogen peroxide gas and integrates a gas generator to release hydrogen peroxide to the area to be disinfected. The design specification of the system is generally that the concentration of hydrogen peroxide is 200ppm or higher (Note: hydrogen peroxide is 1ppm, 2mg/m3, 200ppm, 400mg/m3), the relative humidity is 80 points or higher, and the treatment time depends on the size of the area, its bioburden and the obstacles in the area thing. This system has been used in many industrial settings and is now considered as a possible alternative in GMP operations.
Whenever chemicals are used for large-scale gas treatment or atomization in cleanrooms, bixu considers anquanity. All of the disinfectants in question can cause personal injury or death if proper precautions are not taken to ensure that chemical disinfectants are contained in the area to be treated.
For most of the disinfectants discussed, residue on surfaces in contact with the product is also an important issue, bixu assessed.
While these disinfection methods are effective, they are not intended to replace routine procedures for cleaning and disinfecting cleanroom areas. If used as standard practice, they should be validated to demonstrate that they can