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.
How the Finn-Aqua BPS Sterilizer Works
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.
Why Choose Finn-Aqua BPS Sterilizers?
- Durability and Reliability – Chamber material is AISI 316L stainless steel with a maximum carbon content of less than 0.03% to reduce corrosion and help extend chamber lifespan.
- Customization – A broad selection of features and cycles are available for all applications (pharmaceutical manufacturing, research, etc.)
- Easy to Validate – Systems are fully tested and pre-validated during factory qualification under simulated production conditions and provided with full documentation.
- Compliant – Systems are designed, manufactured, tested and documented in adherence to the latest global standards and practices to facilitate compliance with GMP, cGMP, GAMP and other guidelines.
- Productivity – The rigorous design and accurate control system of the Finn-Aqua BPS Sterilizer assure effective and reproducible cycles. Available cycles include B, BX, C, CX, DEC F, DEC V, DEC +C, SAMX, AC, GdT and RP.
- Flexibility – Systems are designed for a variety of demanding applications with cycle versatility to accommodate varying load types and a full range of loading, transfer and other auxiliary equipment.
GMP Statement
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.
GAMP Statement
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.
EU Annex 1 Statement
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.
21 CFR Part 11 Statement
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.
Unique Features & Cycle Alternatives
Finn-Aqua BPS Sterilizers feature a broad and unique set of features and cycles to choose from.