Finn-Aqua® BPS Sterilizers offer reliable performance for the most demanding GMP and research applications. For over 40 years, STERIS has delivered flexible and customized sterilizers to biopharmaceutical, pharmaceutical, research and development facilities.
Finn-Aqua BPS Sterilizers can be utilized for a variety of applications, including sterile room supply, media preparation and terminal sterilization of hard goods, vented liquids and sealed packaged liquids. They also support decontamination of loads within biosafety classified applications.
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Finn-Aqua BPS Sterilizers provide shortened validation time, increased flexibility and unsurpassed reliability in applications including sterile room supply, media preparation and terminal sterilization of hard goods, vented liquids and sealed packaged liquids. They also support decontamination of loads within biosafety classified applications.
Finn-Aqua BPS Sterilizers are optimized to facilitate your most demanding biopharmaceutical, pharmaceutical, research and development applications.
Finn-Aqua BPS Sterilizer cycles are pre-programmed and selected via a “recipe” list. Most parameters are user customizable and exposure temperatures are maintained within +/- 0.5 °C.
For applicable sections, the design and construction of Finn-Aqua BPS Sterilizers follows current Good Manufacturing Practice (cGMP) as enforced by the United States Food and Drug Administration (FDA) and European GMP regulations.
Finn-Aqua BPS Sterilizers follow the GAMP 5, A Risk-Based Approach to Compliant GxP Computerized Systems.
GAMP 5 is built around a Risk-Based Management System for the development, supply and maintenance of automated systems by a supplier. Adherence to this management system by the supplier provides both the system and sufficient documentary records to enable the complete system to be accepted and validated by the user. GAMP provides documented evidence and a high degree of assurance that the specific process will consistently produce a product meeting its pre-determined specifications and quality attributes.
Finn-Aqua BPS Sterilizers designed for pharmaceutical, biopharmaceutical and medical device manufacturing applications conform to applicable requirements of the current EU Annex 1: Manufacture of Sterile Medicinal Products.
STERIS develops, documents and enforces policies and procedures that ensure the security of electronic records, according to 21 CFR Part 11/EU Annex 11. Together with our Customers, STERIS will assist with the implementation and enforcement of 21 CFR Part 11/EU Annex 11 by providing compliant solutions involving validation, audit trails and security of computer systems. Please refer to additional options for added electronic data security features.
Finn-Aqua BPS Sterilizers feature a broad and unique set of features and cycles to choose from.
Certificates of manufacture/analysis for consumable products by product ID and lot number. (Adobe® Acrobat® Reader required)