Pure Steam (PS) is a high-grade steam that, when condensed, meets the stringent quality standards required for Water for Injection (WFI). This type of steam is considered a critical clean utility within the pharmaceutical and life science industries, as it plays a vital role in ensuring the sterility and cleanliness of various production processes and equipment.
Pure Steam is primarily used for the sterilization of product-contact surfaces, such as equipment, piping, and containers, which come into direct contact with pharmaceutical products. Sterilization through steam ensures that any microorganisms, particulates, or contaminants are effectively eliminated, making it an essential element in maintaining high standards of hygiene and safety. Pure Steam is also used for air humidification in cleanroom environments, ensuring that the controlled air supply within these highly regulated areas remains free of contaminants while maintaining the required humidity levels.
In addition to its widespread use in pharmaceuticals, Pure Steam is also used in other industries where sterility and cleanliness are paramount, such as biotechnology, cosmetics, and food production. The ability of Pure Steam to meet WFI standards ensures that it is free from endotoxins, minerals, and other impurities, making it suitable for applications that require high-purity environments.
Application Fields:
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- Pharmaceutical: Pure Steam is extensively used for sterilizing equipment and components in pharmaceutical manufacturing, ensuring that all product-contact surfaces are free from contaminants. It is also used to humidify the air in cleanrooms and isolators, maintaining the required environmental conditions for sterile production processes.
- Cosmetic: In the cosmetics industry, Pure Steam is used in the sterilization of equipment and containers that are in direct contact with skincare and beauty products, ensuring that the manufacturing process remains clean and safe.
- Biotechnology: Biotechnology facilities often rely on Pure Steam to sterilize equipment used in research, production, and laboratory environments. This helps maintain the purity of biologic materials and minimizes the risk of contamination during sensitive production processes.
- Food and Beverage: Pure Steam plays an important role in food and beverage production, particularly in sterilizing equipment and piping systems. Its use ensures that products remain uncontaminated during processing, contributing to the overall safety and quality of the final goods.
- Veterinary: In the veterinary industry, Pure Steam is utilized to sterilize equipment used in the development and production of veterinary medicines, ensuring that the highest standards of cleanliness and safety are met.
- Industrial: In various industrial applications, particularly those involving sensitive or high-purity products, Pure Steam is used for sterilization purposes and to maintain clean environments where contamination control is crucial.
The widespread use of Pure Steam across multiple sectors highlights its importance as a reliable and effective clean utility that ensures sterility and compliance with strict regulatory standards.