Purified Water Storage and Distribution Skids, Distribution Loop

Product Details

Purified  Water Storage and Distribution Skids, Distribution Loop
Water  is an essential component of pharmaceutical formulations.

Purified  Water (PW), Low Pyrogen Purified Water (LPW) and Water for Injection (WFI) are  highly regulated ingredients requiring assurance that microbiological  contamination is prevented.
Purified Water Storage and Distribution  Skids from GMPMax are modular designed and can include:  

Storage Tank  

Centrifugal  Pump

Heat  Exchanger

Ultraviolet Radiation  Equipment

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  hot water sanitization or Ozone 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 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

UV  with intensity monitor and recording for Purified water systems, 3 No. Ozone  generators for Ozonated systems for Ozone  Sanitization

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

LOOP  with Hot Water Sanitization

It is a compact system  for the Storage, distribution, sanitization & monitoring of Purified Water,  Highly Purified Water. Variable speed drive pump for distribution of the pure  water, UV radiation unit for prohibit the bacteria from growing, flow rate  temperature & conductivity measurement (with online TOC measurement as an  option).

LOOP with Ozone  Sanitization

With the compact  system, the entire storage & distribution system can be sanitized by adding  ozone (generated from Purified Water itself) to the circulating water. This  eliminates the requirement to periodically shutdown the system for Hot Water  Sanitization. Microbial counts less than 010CFU/100 ml without maintaining PW  Loop at 80 ℃ can  be obtained using this system.

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