Superheated water sterilizer for large volume parenterals
In the pharmaceutical and biotechnology industries, sterilizing large volume parenterals (LVPs) such as liquids in sealed containers poses challenges due to the sensitivity of the products to heat and pressure, as well as the risk of container deformation during the sterilization process.
Perform counterpressure sterilization with superheated water
The FOW Superheated Water Sterilizer by Fedegari is designed for the counterpressure sterilization of large volume parenteral solutions using a superheated water spray system. This system adheres to cGMP and FDA standards, ensuring compliance and safety. The FOW sterilizer addresses the issue of container deformation by equalizing pressure inside the chamber and the containers. For products susceptible to separation or requiring rapid temperature transitions, the load can be rotated during the sterilization process. This results in more uniform heat distribution and improved sterilization efficiency. The system allows for faster process times compared to air-steam sterilization and is suitable for temperatures below 105°C. The Thema4 process controller, pre-validated according to GAMP5 and compliant with 21 CFR Part 11, facilitates easy integration with SCADA and other Fedegari systems, minimizing qualification time and project risks.
Benefits
- Ensures compliance with cGMP and FDA standards
- Prevents container deformation through pressure equalization
- Facilitates rapid thermal transitions with rotating load capability
- Reduces process time compared to air-steam sterilization
- Allows easy validation and integration with existing systems