Kaye Solutions Dry Heat Sterilization
Hot Air Sterilization: An Overview of Methods and Standards
Hot air sterilization, also known as dry heat sterilization or depyrogenation, is a critical process for the removal of pyrogens and microorganisms from materials such as glassware and metal parts. This method is frequently used in the pharmaceutical and biotech industries and operates at high temperatures, typically up to 350+ ºC/ 662+°F or more. For effective sterilization, it is essential that both temperature and exposure time are precisely controlled to ensure the complete destruction of microorganisms.
The documentation of these parameters within the framework of IQ/OQ/PQ (Installation Qualification, Operational Qualification, and Performance Qualification) is important. These parameters must also be determined during the regular, annual qualification of the equipment according to existing norms and regulations in the GxP (Good Practice) area.
Static applications such as dry heat ovens provide a reliable method for sterilizing surgical instruments, glass vials, and other medical devices through the even distribution of hot air. This uniform temperature distribution is essential for an optimal sterilization outcome.
Continuous sterilization tunnels are another proven technology in hot air sterilization. They enable the continuous sterilization of products, such as vials, before they are fed into the filling line. This method offers efficient and safe sterilization, especially for large quantities.
For further information on normative requirements and guidelines, it is advisable to consult relevant ISO standards such as ISO 20857 (Sterilization of health care products – Dry heat – Requirements for the development, validation, and routine control of a sterilization process for medical devices) or other pertinent regulations as a basis.
The Kaye AVS (Automated Validation System) and ValProbe-RT validation systems are ideal for the qualification and validation of dry heat sterilizers, both in static applications and in sterilization tunnels. Our innovative monitoring technologies ensure process safety and high operational efficiency, ultimately enhancing the quality and integrity of pharmaceutical products.
For more information on our products and solutions, please visit our website. We are happy to assist you with customized solutions for your specific requirements in the pharmaceutical and biotechnology sectors.