GMP steam sterilizer for applications such as sterile room supply, media preparation,and terminal sterilization of hard goods, vented liquids, and sealed packaged liquids in biopharmaceutical, pharmaceutical, biotech research, and development facilities.
STERIS’ Finn Aqua Bio Pharma Series GMP Steam Sterilizer provides shortened validation time, increased flexibility, and unsurpassed reliability in applications such as sterile room supply, media preparation and terminal sterilization of hard goods, vented liquids and sealed packaged liquids.
STERIS’ Finn Aqua Bio Pharma Series GMP Steam Sterilizer cycles are selected via a recipe list. Most parameters are user selectable. Cycle progresses through programmed cycle. Exposure temperatures are maintained within +/- 0.5C.
• Easy to Validate – Systems are fully tested and pre-validated during our factory qualification under production like conditions and full documentation.
• Compliant – Systems are designed, manufactured, tested and documented according to the latest global standards and practices to facilitate compliance with GMP, cGMP, GAMP and others.
• Productivity - Rigorous design and accurate control system assure effective and reproducible cycles. Available cycles include B, C, G-delta T, AC, SAMX and RP.
• Flexibility – Systems are designed for different/demanding applications with cycle versatility to accommodate varying load types and a full range of loading, transfer and other auxiliary equipment.
• Reliability – Chamber material is AISI 316L SS with maximum carbon content of less than 0.03% to reduce corrosion and help extend the life of your chamber.
STERIS FINN-AQUA follows 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.
The standard unit and all standard options are built according to GAMP 5 guidelines.
Special features will be designed and assembled in compliance with GAMP 5, but the GxP risk assessment of the customer-specified features will remain the responsibility of the specifying party.
Finn-Aqua control system software does not contain ‘dead’ code. ‘Dead’ code is defined by GAMP 5 A Risk-Based Approach to Compliant GxP Computerized Systems, February 2008 Appendix D4: Guideline for Management, Development and Review of Software, paragraph 3.1.6; Removal of Dead Code.
21 CFR Part 11 Statement
STERIS Finn-Aqua develops, documents, and enforces policies and procedures that ensure the security of electronic records and signatures according to 21 CFR Part 11. Together with our customers, Finn-Aqua will help implement and enforce Part 11-compliant solutions involving validation, audit trails, and security of our computer systems.
Certificates of manufacture/analysis for consumable products by product ID and lot number. (Adobe® Acrobat® Reader required)