The latest dynamic observation of VHP sterilizer and VHP sterilization system

Abstract: Taking the MQ series sterilization system of low temperature vaporized hydrogen peroxide (VHP sterilizer) developed by Zibo Weishi Medical Technology Co., Ltd. as an example, the latest technical trends of VHP sterilizer are introduced, and its management in GMP is discussed. Aspects of the advantages.

Key words: VHP sterilizer; equipment characteristics; GMP;

In the already published version of China's 2010 GMP, the production requirements for sterile drugs have been greatly improved. Moreover, sterilization has always been a key part of the production of sterile pharmaceuticals. In order to improve the quality of the drug, it is particularly important to choose an appropriate sterilization method.

Among various sterilization techniques, the bactericidal performance of liquid hydrogen peroxide has been recognized more than 100 years ago. However, liquid hydrogen peroxide requires a high concentration and a long contact time to have sporicidal ability. Later, it was found that gaseous hydrogen peroxide has a higher sporicidal ability than the liquid state at a low concentration. The main principle is to generate free hydrogen groups for attacking cellular components, including lipids, proteins and DNA. Based on this, Zibo Weishi Medical Technology Co., Ltd. has designed a new type of low temperature vaporized hydrogen peroxide (VHP sterilizer) MQ series sterilization system suitable for the pharmaceutical industry, which can be widely used in pharmaceutical product packaging and diagnosis. The instrument is sterilized.

1, equipment characteristics

The MQ Series VHP sterilizer provides an efficient low temperature sterilization method that utilizes vaporized hydrogen peroxide as a sterilizing agent for sterilization. The unit is designed as a self-contained unit that is fully integrated into the production line. The sterilization cycle time is greatly reduced compared to conventional sterilization methods. The control system of the equipment can control the sterilization cycle, selection and monitoring throughout the process, and realize the full automation of the process. The touch screen design makes the operation of the system easier. Moreover, the sterilization method of the device has good material compatibility and is suitable for many metals and plastics. After sterilization, only non-toxic residual substances such as oxygen and water are produced. VHP sterilizers have a broad spectrum of bactericidal action against microorganisms and are suitable for killing various fungi, bacteria, viruses and spores.

In addition, the VHP sterilizer has the following features:

(1) Independent temperature and pressure cycle detection system;

(2) Designs that meet GMP requirements;

(3) Applicable to parameter release;

(4) Permanent programming of the cyclic program;

(5) By-products such as water vapor and oxygen meet environmental protection requirements;

(6) No additional ventilation and detoxification equipment is required;

(7) No plasma is required.

2, equipment structure and working principle

2.1 Equipment structure

The MQ series sterilizer is mainly composed of the following parts:

(1) Temperature control table;

(2) Built-in printer;

(3) Touch the display screen;

(4) sterilization chamber;

(5) sterilizing agent vaporization chamber.

In addition, the inside of the sterilization cycle also includes an ejector, a vacuum pump, a catalyst, and the like.

2.2 Working principle of the device

The sterilization cycle of a hydrogen peroxide sterilizer is divided into three phases: pretreatment, sterilization, and ventilation, wherein the pretreatment also includes a leak test of the device prior to the start of the sterilization cycle. Leakage test: All valves in the sterilization chamber are closed, and the pressure rise in the cabin is observed by the differential pressure gauge. If the rate of pressure rise meets the requirements of the preset procedure, the system is considered to be closed and pretreatment can be started.

(1) Pretreatment: Open the ventilation valve and fill the cabin with dry, sterile air. The sterilized articles are dried to facilitate the full diffusion of hydrogen peroxide in the sterilization chamber and then enter the sterilization period.

(2) Sterilization: After the hydrogen peroxide solution is injected into the vaporization chamber through the peristaltic pump, it is rapidly vaporized into hydrogen peroxide vapor, filtered through a high-efficiency filter and injected into the sterilization space until the target sterilization concentration of VHP is reached, and vaporization is achieved. The high injection rate of hydrogen peroxide in the stage will quickly reach the target sterilization concentration in the sealed space.

(3) Ventilation: During the ventilation phase, the Danfoss refrigeration system performs condensation and dehumidification of the cavity. The collected hydrogen peroxide solution is removed by the peristaltic pump line, and the palladium catalyst degradation unit degrades the hydrogen peroxide gas; When the concentration of hydrogen peroxide is less than 75ppm, the air inlet valve of the air inlet valve is opened, and the EBM speed control exhaust fan is operated to accelerate the gas replacement of the cavity and shorten the ventilation and disassembly time.

2.3 Confirmation of sterilization effect

The bactericidal effect identification is mainly verified by a chemical indicator card and a biological indicator.

(1) Chemical indicator card detection:

To detect the concentration of hydrogen peroxide. When using, place the chemical indicator card in the center of the package to be sterilized. After the sterilization is finished, take out the chemical indicator card and observe the color of the chemical indicator card. It is qualified from blue to beige.

(2) Biological indicator detection:

It is usually verified by Bacillus stearothermophilus. In use, the biological indicator is placed in the center of the package to be sterilized. After the sterilization is finished, the biological indicator is taken out, the cover is vertically held in the hand, and the bottle is sterilized by a special tool, so that the culture liquid flows out of the immersion. The bacteria pieces were observed after culturing at 55 to 60 ° C for 4 days. Keeping the medium in purple is considered as sterile growth, and the positive control medium is qualified from a purple clear liquid to yellow or turbid.

3. GMP compliance study

The MQ series hydrogen peroxide sterilization system eliminates the need for additional ventilation and detoxification equipment. The oxygen and water generated by the sterilization can be directly discharged, which not only saves the cost of the manufacturer, but also is more economical and environmentally friendly. The independent unit design is fully integrated into the current production line, reducing finished product inventory and reducing delivery time. The small size greatly facilitates the installation, disassembly and easy cleaning of the device. Through the above analysis, it is not difficult to see that the device is more in line with GMP standards [3].

4, the conclusion

The MQ series hydrogen peroxide sterilization system is a new equipment for low temperature sterilization and sterilization. It has been widely used in food, medical and health, pharmaceutical industry, bioengineering, disease prevention and control, inspection and quarantine. Because of its rapid, non-toxic, environmentally friendly and easy to install and use, it has attracted more and more attention and attention from the pharmaceutical industry, and is rapidly becoming the mainstream product in the pharmaceutical low-temperature sterilization equipment market.

Supplier Extract Powder

We're Professional Supplier Extract Powder manufacturers and suppliers in China specialized in providing high-quality products at low price. We warmly welcome you to buy or wholesale bulk Supplier Extract Powder for sale here from our factory. For a free sample, contact us now.