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With the implementation and promotion of the new version of GMP, corresponding requirements have been put forward for the production of sterile drugs. Sterilization has always been a key part of sterile products.In order to improve product quality, it is particularly important to choose a suitable sterilization method.

Among the various sterilization technologies, hydrogen peroxide sterilizers are recognized as the ideal sterilization method.Hydrogen peroxide vapor (VHP) disinfection technology is rapidly becoming the choice of biological purification methods in the pharmaceutical, biotechnology and medical and health industries. The killing rate of Bacillus thermophilus with the same biological indicators as pressure cookers has reached 6-log.This sterilization method has been widely used in pharmaceutical, biotechnology, biomedicine, healthcare, biology, food, environmental protection and many other fields.

Disinfection principle of hydrogen peroxide disinfection machine：
Hydrogen peroxide has a bactericidal effect because of its redox effect, especially for anaerobic bacteria. It dissociates highly active hydroxyl groups through complex chemical reactions and is used to attack cellular components, including cell membranes, lipids, proteins, DNA, etc.

Liquid H2O2 is converted into VHP by "flash", which can be effectively carried out at room temperature and humidity without special pretreatment such as dehumidification.The VHP is evenly introduced into the confined space, and the inner surface is completely exposed to the VHP, forming a layer of about 1m hydrogen peroxide film, attached to the surface of a possible resident microorganism.The microorganism itself will be wrapped in micro-condensation as the core, and will be quickly killed by this process.

The purpose of sterilization is to kill the 6-log biological indicator double, the commonly used double is Bacillus thermophilus.After disinfection, VHP is catalytically decomposed into water vapor and oxygen.It can also be completely decomposed by using a powerful ventilation device, or by using a building air-conditioning and ventilation system.For freeze dryers, its vacuum system can be used to quickly remove residual VHP.

Disinfection process of hydrogen peroxide disinfection machine
(1) Conditioning preparation: The evaporator of the hydrogen peroxide generator is stable at about 120~130, which takes about 5~10 minutes.
(2) Inflatable intake: Use an easy-to-obtain medical-grade 30%~35% w/w hydrogen peroxide solution, which is dynamically sprayed into the target area after the generator evaporates (flashes) instantly.Use the nozzle to increase the steam flow rate to close to 30.48m/s, while rotating horizontally and vertically to ensure
(3) Stay and maintain: The hydrogen peroxide sterilizer maintains a certain time range in the target area to ensure complete biological killing.This process completely and additionally exposes the target area to hydrogen peroxide vapor to ensure a successful result.
(4) Aeration and ventilation: use the ventilation system of the facility to discharge steam from the target area, or use a ventilation device to quickly catalyze the decomposition of steam into water and oxygen.When there is no suitable valve or it is not easy to control, it makes sense to adopt an independent ventilation system.

Since the concept of VHP sterilization was born, this technology has evolved from focusing on small enclosed systems such as isolators and transfer compartments to larger spaces such as rooms, suites and even entire buildings.