SteriBowl is the first Steam-Sterilizable Isolator designed to clean and sterilize in place (SIP) vibratory bowls and indirect contact components. Eliminating the need for disassembly, SteriBowl provides a revolutionary approach that enhances sterility assurance while reducing setup time in aseptic filling lines.
Introducing
Ensuring Compliance with Annex-1 & FDA Regulations
With the implementation of Annex-1 in 2022, the pharmaceutical industry faced new sterilization challenges. Traditional methods, such as Vaporized Hydrogen Peroxide (VHP), fail to penetrate beneath the silicon layer of vibratory bowls and lanes. As a result, compliance with sterilization standards became increasingly difficult.
Key benefits
After Sterilization cycle has been completed, there is no need for human intervention to re-install vibratory bowls into isolators and the sterile environment is upgraded with both unidirectional sterile airflow and dedicated systems to monitor viable/non viable presence as in standard Grade A isolators.
Main Features
Vibratory bowls and lanes are sterilized within the production line using steam, without the need for disassembly or relocation. SteriBowl is the first prototype currently undergoing qualification. This includes the technical solutions necessary to ensure that the air filters are sterilized and tested, a unidirectional flow is created by a CG type diffusor capable of withstanding clean steam, the membranes and machine parts are not damaged by temperature and pressure differences, environmental monitoring does not compromise sterility, and a SAL of 10-12 can be guaranteed.
The Ultimate Hybrid Isolator-Autoclave Solution
Innovative Design & Advanced Sterilization Technology
SteriBowl combines the proven effectiveness of saturated steam sterilization with cutting-edge isolator technology, creating a comprehensive solution for aseptic processing.
