Water-Cascade Sterilizer
Kaye Solutions for Water Cascade Autoclaves
Water Cascade or Waterfall Sterilizers are specialized moist heat sterilizers used for sterilizing temperature-sensitive products and materials. They allow for the elimination of germs and microorganisms without damaging the products through high temperatures. This method is mainly applied in the medical and pharmaceutical industries, as well as partially in food processing.
Principles of Water Cascade Sterilization:
The operation of these sterilizers is similar to steam sterilizers or autoclaves, with the main difference being the temperatures and cycle times used. While classical steam autoclaves typically reach temperatures between 121°C/ 250°F and 134°C/ 274°F, Water Cascade Sterilizers operate at lower temperatures, usually below 110°C/ 230°F.
Critical Sterilization Parameters:
- Temperature:
Defining the exact temperature is crucial for the effectiveness of sterilization. This is achieved by hot water spraying over the objects to be sterilized. - Time:
Working at lower temperatures requires longer sterilization times to achieve the same microbial kill rate as higher temperatures. - Pressure:
During the sterilization process, an overpressure is generally maintained to ensure the penetration of hot water and uniform heat distribution.
Measurement and Control of Sterilization Parameters:
To ensure reliable and reproducible sterilization, temperature, time, and pressure must be continuously monitored and precisely controlled. These critical sterilization parameters must also be documented during Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) as well as during regular annual qualification and validation to ensure compliance with applicable regulations. Standards such as ISO 17665-1 for moist heat sterilization and guidelines from the US FDA and the European Medicines Agency (EMA) must be considered.
Applications and Benefits:
Water Cascade Sterilizers are especially suitable for products that could be damaged by high temperatures. These include:
- Medical devices made of plastic
- Pharmaceutical products like nutrient solutions and eye drops
- Food packaging
- And many others
Thanks to the ability to use lower temperatures and longer sterilization cycles, Water Cascade Sterilizers offer a gentle and effective method for sterilizing temperature-sensitive products. The Kaye AVS and ValProbe-RT validation systems are ideal for the qualification and validation of Water Cascade Autoclaves and the sterilization of temperature-sensitive products with moist heat. These modern monitoring technologies ensure process safety and high operational efficiency, which ultimately enhances the quality and integrity of pharmaceutical products.
For more information about our products and solutions, please visit our website. We are happy to support you with tailored solutions for your specific requirements in the pharmaceutical and biotechnology industries.