Water for Injection Storage and Distribution Skids, Distribution Loop
Water is an essential component of pharmaceutical formulations.
Water for Injection (WFI) is highly regulated ingredients requiring assurance that microbiological contamination is prevented.
WFI Storage and Distribution Skids from GMPMax are modular designed and can include:
Standard System Features
PLC Controlled with touch screen HMI
Modular design on stainless steel frame
Automatic superheated hot water sanitization
Flexible outputs from 1.5 to 45 m3/hr
Condensed footprint with optimal accessibility
316L stainless steel pipe work to ASME BPE, internal surface finish < 0.5 Ra. (SFT1)
20% boroscope weld inspection
Validation to regulatory and client standards
Optimized life cycle cost
Standard interface with generation system Fully Drainable, with one drain connection
Designed for robust and safe operation
Exceptional High quality (in-house) build in ISO certified factory
Client witnessed factory acceptance test (FAT)
All components are sourced from leading global suppliers to ensure highest quality and local sources available for spares.
Sanitary centrifugal pump including drain valve with Variable speed drive control
Shell and Tube heat exchangers (DTS style) for ultimate security and low maintenance for superheated hot water sanitizable SKID
Sanitary flowmeter – fully drainable
Non compensated conductivity meter
Heated 0.2micron sterile vent filter (fitted to tank) Sanitary bursting disc with contact alarm (fitted to tank)
Sanitary sampling valves connected to common drain
Inline TOC meter – option
Orbitally welded with Triclamp mechanical joints to equipment/instrumentation
Siemens S7 PLC with touch screen HMI to allow ease of operation and monitoring.
Control and monitoring from a single interface with data logging facilities and links to user BMS/SCADA systems.
GAMP and 21 CFR 11 compliant with electronic signature and data logging
The control system has the flexibility to operate complete turnkey packages allowing customers to reduce costs and simplify operation using a single access interface for pre-treatment, purification, storage and distribution.
Flowrate, temperature and conductivity measurement with TOC as an option
Standard system can monitor and control up to 12 Automatic user points
Good Engineering Practice (GEP)
Pumps to be deliver fully turbulent flow.
Heat exchangers to be double tube sheet shell and tube type, allowing visibility of any leakage.
User point to be Zero dead leg/GMP user point (3D).
Return flow of loop will be above 1.5m/second.
All pipes in contact with PW are orbital welded or joined with TC connection.
20% X-ray test or baroscopic test to ensure sanitary system.
Pipe work to be installed to achieve minimum slope at 1% to allow self-draining and deflection will be accepted.
Pipe work to be handled assuring permanent protection of pipes ends from dirt and contamination (caps) for any loop component.
All necessary support devices, user point apparatus (plant area/room/clean room) to be provided and installed by GMPMax audited supplier.
Supports can give enough flexibility (extension) for thermal sterilization (90°C) distance between two supports limited to 3m
Components and distribution lines to be sloped and fitted with drain points so that system can be drained of completely
Flow rate to be sufficient so that there’s not any, no flow or low flow conditions which are conducive to microbial proliferation and development of bio-film, particularly in water distribution pipelines
Orbital welds to be executed, welders are qualified and valid qualification certificates to be provided before start activity on site
Orbital welding machine will have valid qualification certificate
Welders will produce approved test piece at least daily (if no shutdown of welding machine during lunch time)
Each test piece to be approved by customer before starting production
Test pieces are to be kept by customer as sample