Water for Injection Storage and Distribution Skid, Distribution Loop

Product Details

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