Steris Finn Aqua BPS Bio Pharmaceutical Steam Sterilizer System 6615-N-B-BPS-AB

Steris Finn Aqua BPS Bio Pharmaceutical Steam Sterilizer System 6615-N-B-BPS-AB

***The system is new and unused. IQ/OQ was completed and system is in ideal working condition. The system was professionally uninstalled. Buyer can expect everything pictured with 30-day warranty. See photos for details.**

Includes:

• Steris BPS Bio Pharmaceutical Sterilizer 6615-N-B-BPS-AB
• Steris POU-400 Point-Of-Use Pure Steam Generator
• Steris Power Pack Electric Steam Boiler CH12-861-500 
• Millipore Milli-Q HX 7040 Water Purification System
• Millipore SDS500 Duplex Pump
• Transport Cart

Steris BPS Bio Pharmaceutical Sterilizer 6615-N-B-BPS-AB

The Steris Finn-Aqua Bio Pharma Series (BPS) GMP Steam Sterilizers is designed for general purpose, sterile room supply, media preparation, or terminal sterilization applications performed in biopharmaceutical and pharmaceutical facilities, and biotech research and development facilities

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's Finn-Aqua® BPS Bio Pharmaceutical 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.

How the Finn-Aqua BPS Bio Pharmaceutical Sterilizer Works

STERIS’ Finn-Aqua BPS Bio Pharmaceutical 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.

Why Finn-Aqua BPS Bio Pharmaceutical Sterilizers?

• 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.

GAMP Statement

STERIS's 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's 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.

Unique Features & Cycle Alternatives

The unique features and cycles of our BPS GMP steam sterilizers product line are highlighted in the below videos showing the differentiating features unique to the Bio-Pharma Series GMP Steam Sterilizer. Watch them both to learn about the functions of the BPS GMP Sterilizer.

Steris POU-400 Point-Of-Use Pure Steam Generator

An economical solution for generating Pure Steam in environments which lack a centralized, plant wide pure steam / water system.

STERIS Finn-Aqua’s Point-Of-Use Pure Steam Generator is a compact and economical solution for generating pure steam in environments that lack a centralized pure water/steam system or need additional capacity. The unit, which features its own controller, can be used as a stand-alone steam generator for a variety of applications or can be integrated into
equipment such as steam sterilizers which require pure steam

Advantages:

• Economical Pure Steam solution serves a variety of applications, reducing building and renovation costs for drug and device makers, research laboratories and other Life Science organizations
• Meets pharmaceutical grade specifications and offers the reliability and quality that has made Finn-Aqua famous
• Compact, simple design offers easy operation and maintenance in small footprint

Applications:

• Primary pure steam source for pilot production, laboratories, hospitals and other facilities requiring low capacity
• Integrated pure steam source for sterilizers
• Added capacity for central steam
• systems to cover plant shut-downs or peak demand periods
• For use in sterilization of water tanks and loops
• For use as a humidifier in HVAC systems

Steris Power Pack Electric Steam Boiler CH12-861-500

• Power Volts-  480
• Power Amps- 144
• Phase- 3
• KW-120 
• Max Lbs/Hr- 420
• MAWP- 100 PSIG

Millipore Milli-Q HX 7040 Water Purification System

The Milli-Q^® HX 7000 SD series represents a new range of high-throughput water purification systems. These systems provide a complete, compact and fully-customizable pure water solution for large laboratories requiring a few hundred to up to 3000 L/ per day of Type 2 pure water. This solution allows a distribution flow of up to 20 L/min for small and mid-size loop. This enables one Milli-Q^® HX 7000 SD system to reliably supply the pure water needs of a large laboratory or an entire floor of a building. Elix^® water quality is ideal for the preparation of reagents and buffers, for microbiology media, hydroponics or histology. It is also the best feed for all Milli-Q^® and high-throughput Super-Q^® ultrapure water systems, as well as equipment such as glassware washers, clinical analyzers, stability chambers, humidifiers, weathering test equipment, and autoclaves.

Millipore SDS500 Duplex Pump

The SDS 500 storage and distribution system is designed to store purified water (up to 460 L), provides optimal protection against airborne contaminants, and distributes pure (Type 2 or Type 3) water to multiple locations under pressure. The distribution flow rate is up to 40 L/min. This storage unit along with Milli-Q^® HX 7000 and Milli-Q^® HR 7000 high-flow water purification systems, covers a wide range of installation needs, from a single lab to an entire building.

• Complete storage & distribution system for pure (Type 2/3) water 
• Stores up to 460 L
• Distribution flow rate is up to 40 L/min
• Supports Milli-Q^® HX/HR systems

SDS 500 Duplex Pump 100 V/127 V 50/60 Hz