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:

Storage Tank

Centrifugal Pump

Heat Exchanger

Main instrumentation:

Level Transmitter

Conductivity sensor

Flow Meter

Temperature Probe

Pressure Transmitters

Control Cabinet

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)

System components

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

System control

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

Key Words:

Pharmaceutical Machinery, Pharmaceutical Engineering, Pharmaceutical Equipment,
Packaging Machinery, GMP Machinery, Pharmaceutical Industry, Pharmaceutical Technology

cGMP Service, cGMP Solutions, cGMP Validation