With the application of hydrogen peroxide sterilization technology in high-clean places such as biopharmaceutical plants, the process, verification methods and critical control points of using hydrogen peroxide for isolators and clean spaces are very important, therefore, the advantages and disadvantages of hydrogen peroxide steam sterilization technology have become the key elements that must be considered in the selection of sterilization methods in clean areas of biopharmaceutical plants. Biopharmaceuticals have high requirements for the sterilization effectiveness of the clean area, and must have at least the following five requirements: (1) the use and operation are simple and convenient, and will not cause danger to personnel and the environment; (2) The sterilization efficacy needs to meet the sterilization standards stipulated in the 2020 edition of the Pharmacopoeia, that is, it can achieve a lethality rate of 104~106 for Bacillus subtilis and Bacillus thermophilus: (3) Good material compatibility and will not cause damage to the equipment in the clean fishing area, color steel plate, ring gas resin ground, high-efficiency air supply outlet, same air outlet, glass, etc.: (4) No residue, the residue of disinfection and sterilizant after fertilizer sterilization will not constitute any form of pollution to the drug: (5) The diffusion part is good, It can spread to all directions in the sterilized environment without leaving dead corners.

The traditional sterilization methods of pharmaceutical plants mainly include disinfectant wiping method, ultraviolet lamp irradiation method, formaldehyde re-evaporation sterilization technology, ozone sterilization, etc., these methods have poor repeatability, difficult to verify, destructive, need to consume a lot of manpower, and will endanger the health of operators and other shortcomings, in order to solve the above problems, in recent years, vaporized hydrogen peroxide steam sterilization technology has been introduced, according to the requirements of relevant laws and regulations, it is necessary to verify the sterilization effect of using hydrogen peroxide sterilization technology, and process for biopharmaceutical clean areas. Standardized sterilization methods provide guidance and assistance.

In today's pharmaceutical industry, hydrogen peroxide has gradually replaced the traditional sterilization method, becoming a common method of surface or space disinfection and sterilization, hydrogen peroxide is composed of water and oxygen, both are very safe, due to the hydrogen bonding to produce "viscous molecules", resulting in hydrogen peroxide-based vapor is not easy to diffuse, which may produce certain challenges to the vapor distribution in the sterilization process, and the poor diffusion of xenon peroxide vapor in the sterilization process may have a certain impact on the safety parts used, because the vapor of the leaking source is more inclined to "hover" At the leakage site, it is not easy to spread without external force. Therefore, it is necessary to provide additional kinetic energy to promote vapor diffusion, and the common practice is to use an injector, etc.

Safety: Use steam sterilization to limit access throughout the sterilization process, and can be safely restored if sterilization fails.

Reliable: Through vaporized hydrogen peroxide sterilization treatment, the logarithmic value of air and surface sterilization in the sealing barrier can reach 104 ~ 106, and the whole sterilization process is simple and reliable

Intelligent: It can be integrated with building facilities and BMS, and the operator can be replaced in the entire disinfection process to reduce the dependence on operators.

Standardization: The combination of hydrogen peroxide sterilization technology and air conditioning system can effectively avoid the problems of traditional sterilization methods that are difficult to standardize and verify

At present, the common hydrogen peroxide disinfection methods in pharmaceutical plants mainly include vaporized hydrogen peroxide, air source atomized hydrogen peroxide and power supply atomized hydrogen peroxide sterilization

Measurement and evaluation of disinfection effectiveness: For pharmaceutical companies, disinfection requirements vary depending on the level of clean area. In the case of Grade B zone, the spores of Steatobacterium jelly in |g6 must be used as a biochallenger to evaluate the disinfection effect

Corrosivity evaluation: It is mainly for the corrosivity evaluation of color steel plate and galvanized sheet materials that are easy to oxidize.

Measurement and evaluation of disinfection process: There are some noteworthy defects in the use of hydrogen peroxide steam for disinfection and sterilization, and a suitable hydrogen peroxide disinfection equipment must take into account the disinfection effect and corrosiveness.