Application of Vaporized Hydrogen Peroxide Space Sterilization in Pharmaceutical Production

Hydrogen peroxide, with the chemical formula of H2O2, is commonly found in aqueous hydrogen peroxide solutions at concentrations of 30% or 35%, and is considered a broad-spectrum bactericide. In pharmaceutical clean rooms, it can create a sterile environment for drug production; in the food industry, it can be used to sterilize food processing equipment and environments to ensure food safety; in the medical field, it can be used for the disinfection of medical devices and the cleaning of ward environments; in the chemical industry, it can also assist in the sterilization of production processes. Based on its significant sterilization effect and environmentally friendly characteristics, hydrogen peroxide is currently recognized as one of the most ideal bactericides in the world.

During the normal operation of the pharmaceutical production workshop, due to the frequent entry and exit of raw materials and intermediates, the core production area urgently needs an efficient and reliable sterilization method. The project faces challenges such as high sterilization frequency, the need to shorten the operation cycle, reduce the impact on the clean room environment, ensure personnel safety, and environmental harmlessness. Finally, a sterilization solution combining a fixed vaporized hydrogen peroxide device with a clean room air conditioning system was adopted.

Vaporized hydrogen peroxide equipment generally includes VHP pass box, VHP isolators, VHP generators, etc. Its process flow is: first dehumidify to control the humidity in the clean area below 60%; then adjust and close the fresh air and exhaust valves, increase the relevant valves, start the generator to quickly increase the VHP concentration, and maintain the humidity at about 55%; then sterilize, maintain a certain VHP concentration to sterilize the system; finally ventilate, close the equipment and valves, open the fresh air exhaust, and discharge the residual hydrogen peroxide through the catalytic degradation device. When the concentration is lower than 1ppm, the ventilation ends and the air conditioning system returns to normal. The sterilization parameters are set as: VHP concentration 650mg/m³, temperature 24-26℃, humidity ≤55%, ventilation frequency>15 times/h. ​

In terms of the design of the clean room maintenance structure, the enclosure structure uses 50mm thick sandwich color steel panel, the floor uses polyurethane colored sand materials, and the panel door uses melamine resin panel doors. In the design of the air conditioning system, the VHP equipment is combined with the air conditioning system, the VHP air supply duct is vertically inserted into the air conditioning air supply duct, and the air conditioning system materials are mostly 304 stainless steel and other VHP-resistant materials. Daily operation and maintenance require the formulation of relevant SOPs and maintenance plans, management of instrument measurements, and training of operators. ​

The combination of VHP sterilization and air conditioning systems has good operability and verifiability, meets the needs of high frequency and short sterilization cycles in clean room drug production, and provides a practical case for clean space sterilization in the pharmaceutical industry.