FINN-AQUA® T-SERIES PURE STEAM GENERATORS
8Pages

FINN-AQUA® T-SERIES PURE STEAM GENERATORS APPLICATION Finn-Aqua T-Series Pure Steam Generators (PSG) are designed to consistently generate Pure Steam for use in clinical research, pharmaceutical and biotech industries. The Pure Steam is used for sterilization applications such as sterilizers, Steam-in-Place (SIP) systems, sterilization of tanks, mixing vessels and Water-for-Injection/Purified Water (WFI/PW) distribution systems as well as for clean room humidification. DESCRIPTION Finn-Aqua T-Series Pure Steam Generators operate based on Finn-Aqua’s original, proven falling film design to remove pyrogenic material. The generators are steam heated and include a Programmable Logic Controller (PLC) for easy operation and monitoring. The Pure Steam Generators are designed, manufactured, tested and documented to current Good Manufacturing Practices (cGMP) compliance. The quality of the generated Pure Steam, when condensed, meets or exceeds the latest versions of U.S., European and Japanese Pharmacopeias WFI specifications. CONTROL □ Siemens □ Allen-Bradley VOLTAGE □ 300-500 VAC, 50 Hz, 3-Phase □ 208-480 VAC, 60 Hz, 3-Phase CONTROL SYSTEM AND INSTRUMENTATION OPTIONS □ Control Cabinet Accessories Upgrade □ Siemens Control System Hardware Upgrade to MP277-8 soft PLC □ SCADA Communication (Siemens Control) □ Allen-Bradley Control Panel Upgrade to PV700+ □ Allen-Bradley Control System Hardware Upgrade to L32 and PV700+ □ Allen-Bradley Upgrade Industrial EtherNet Connection □ Pure Steam Conductivity Monitoring and Sampling Point □ Feed Water Conductivity Sensor □ Feed Water Sample Valve, Diaphragm Type □ Feed Water Sample Valve, Milliflex □ Endress+Hauser Process Instrumentation □ Endress+Hauser Pure Steam Conductivity Monitoring □ Endress+Hauser Feed Water Conductivity Sensor □ One-Channel Pen Chart Recorder for PS □ Two-Channel Pen Chart Recorder for FW and PS □ Six-Channel Paperless Recorder (21CFR Part 11 Compliant) □ Ground Fault Indicator (GFI)/Allen-Bradley Controls MECHANICAL OPTIONS □ Plant (Heating) Steam Pressure Reducing Valve □ Feed Water Gas Separation Option □ Utilities Monitoring and Measurement Option □ Automatic Feed Water Valve □ Manual Pure Steam Shutoff Valve □ Automatic Pure Steam Shutoff Valve □ Feed Water Booster Pump □ Blowdown Cooling Accessories □ Softened Feed Water Option □ Condenser Unit for PSG (Units 250-T - 850-T) □ Stainless-Steel Frame □ Seismic Restraints and Calculations □ Additional Passivation and FAT MANUFACTURING TESTING AND DOCUMENTATION OPTIONS □ Extended Pressure Vessel and Piping Documentation □ Manufacturing Procedures Documentation □ Extended Control System Validation Documentation □ FAT Procedures and Results □ Component Data Sheets/Cut Sheets □ Loop Diagrams □ Additional Copy of Documentation □ Surface Finish Inspection Report (Pressure Vessel and Piping) □ Boroscope Inspection of Pipe Welding on CD □ EP/USP WFI Test □ Endotoxin Challenge Test (Pure Steam and Feed Water) OPTIONAL FACTORY ACCEPTANCE TESTING □ Additional FAT per Day SPARE PARTS □ Spare Parts Kit □ Installation Kit □ Spare Feed Water Circulation Pump

low steam consumption periods The Finn-Aqua T-Series Pure Steam Generators meet the applicable requirements for the following: • Continuous high velocity flushing of the heat transfer surfaces during operation minimizes the risk of fouling and reduced heat transfer efficiency • Current Good Manufacturing Practices (cGMP), CFR Title 21, Part 211, Section D • Continuous separation of pyrogens and other impurities during normal operation • Good Automation Manufacturing Practices (GAMP 5), A Risk-Based Approach to Compliant GxP Computerized Systems Single point power supply • Requires only one...

Control System Alternatives Allen Bradley: • Allen-Bradley CompactLogix™ 1769-L23 with C300 Touch Panel Operator Interface1. • Optional: Allen Bradley CompactLogix™ 1769-L32 with PanelView™ 700 6.5” Color Touch Panel Operator Interface1 Control System Alternatives Siemens: • Siemens Simatic S7-300 PLC, CPU 313C with TP177B 4.3” Wide Screen Color Touch Panel • Optional Siemens Simatic MP277-8 7.5” Color Touch Panel with the software PLC Simatic WinAC MP 2007 Factory Acceptance Test (FAT) / qualification is included for all Finn-Aqua T-Series models. The FAT includes: • Installation Checks...

Control Cabinet Accessories Upgrade. The control cabinet is equipped with cabinet light, electrical socket, 240 V or 120 V, and ventilation grate and ventilation fan to cool down the cabinet. Allen-Bradley Industrial EtherNet connection includes hardware components to enable data reading from Central Processing Unit (CPU) (all Operator Interface [OI's], process steps and alarms). Additionally the unit can be stopped/started and acknowledge the active alarms. Supervisory Control and Data Acquisition (SCADA) Communication (Siemens) contains hardware component (SIMATIC NET SCALANCE...

MANUFACTURING, TESTING, DOCUMENTATION OPTIONS AND SPARE PARTS Extended Pressure Vessel Documentation adds the following material to the standard Manufacturing Documentation: • Pressure Vessel Welding Logs • Welders' Qualifications • Welding Procedure Specifications (WPS) for Pressure Vessels • Passivation Certificate • Electropolishing Certificate Extended Piping Documentation binder adds the following material to the standard Manufacturing Documentation: • Isometric Drawings and Welding Logs • Welders' Qualifications • Welding Procedure Specifications (WPS) for Piping • Material...

UTILITY REQUIREMENTS • Pressure Vessels: » AISI 316L Stainless-Steel Pressure Vessels. Pressure vessels are designed to a pressure rating of 8.6 bar (125 psig) at 178°C (352°F). Pressure vessels built according to ASME/PED or many other international standards » Process contact heat exchangers including the evaporator are of a double-tube-sheet design preventing cross-contamination from lower purity media to higher purity media. The heat exchanger tubes are expanded into the end of tube sheet. » Surface finish in contact with Pure Steam and Feed Water is polished / electropolished to Ra <...