Pure steam sterilization system

The Pure steam sterilization system is a critical equipment widely applied in pharmaceutical, biopharmaceutical, and other industries with strict sterile requirements. It utilizes pure steam generated from purified water as the sterilizing medium to achieve efficient and reliable sterilization of equipment, pipelines, containers, and production environments.

The working principle of this system relies on the high-temperature and high-pressure characteristics of saturated pure steam. When pure steam comes into contact with the surface of the object to be sterilized, it releases a large amount of latent heat, rapidly raising the temperature of the object to above 121°C. Under such high-temperature conditions, the proteins and nucleic acids of microorganisms (including heat-resistant spores) are denatured and destroyed, thereby achieving thorough sterilization.

A series of notable advantages make this system stand out in sterile production. Firstly, it boasts thorough sterilization efficacy, with a killing rate of over 99.99% for various microorganisms, ensuring the sterility of the sterilized objects. Secondly, there is no risk of secondary pollution. Since the pure steam is produced from purified water, it contains no impurities, toxic substances, or residual pollutants. After sterilization, the condensed steam becomes sterile water, which will not introduce new contaminants into the production system, unlike some traditional sterilization methods. Moreover, it is highly compatible with the pharmaceutical industry, perfectly meeting the stringent requirements for sterile environments in pharmaceutical production processes and effectively guaranteeing biological safety throughout the production chain.

The pure steam sterilization system, with its superior sterilization performance and safety, finds extensive application in multiple fields that demand strict sterility control.

In the pharmaceutical industry, it is indispensable for sterilizing key production equipment such as drug manufacturing reactors, mixing tanks, and filling machines, as well as the entire pipeline systems that transport raw materials, intermediates, and finished drugs. It also plays a crucial role in sterilizing packaging materials like glass vials, ampoules, and rubber stoppers before they come into contact with pharmaceuticals, ensuring compliance with GMP standards throughout the drug production process.

Within the biopharmaceutical sector, the system is widely used for sterilizing bioreactors where cell cultures and fermentation occur, along with associated accessories such as filters, hoses, and sampling devices. It effectively eliminates potential microbial contaminants that could compromise the integrity and safety of biological products, including vaccines, antibodies, and recombinant proteins.

In medical device manufacturing, it is applied to sterilize reusable medical devices such as surgical instruments, endoscopes, and dental tools, as well as single-use devices during production to prevent microbial contamination and ensure patient safety.

Additionally, it is utilized in laboratory and research settings for sterilizing laboratory glassware, culture media, and experimental equipment, maintaining sterile conditions for biological experiments, cell culture studies, and pharmaceutical research and development.