PW Generation System

Product Details

GMPMax Sanitary Purified Water Generation Systems are  designed, developed, manufactured, truly pre-validated, pre-tested to exceed  industry standards for USP/EP. The units are customized, modular, skidded in  automated or semi-automated Models as per requirement keeping in mind cGMP  norms, available with a range of output capacities (250L/h to 20m3/h). Compact  modular arrangements have been engineered to minimize installation footprint,  utility connections, and installation efforts. Available pre-validation with Factory  Acceptance Testing (FAT) further minimizes time required for  commissioning at your facility

Typical  Features:

ü  Conception, design and manufacture on the basis of the GMP  guidelines and on the recommendations of the ISPE Engineering Guide and of the  FDA.

ü  Designed with latest standards & norms as per UPS/EP  for Pharmaceutical & Biotech.

ü  An excellent strict Project Management  system

ü  Compact, space-saving, skid-mounted  construction.

ü  Microbiological safety due to use of pipes made of  stainless steel SS 316 L with TriClamp connections, free of dead leg, and a  surface roughness of all parts in contact with the medium of Ra 0.6  µm.

ü  Flexible installation options with various schemes and  automation.

ü  Designed with optimum usage of power and  consumables.

ü  Low maintenance with optimum design.

ü  User friendly and reliable design.

ü  Comprehensive documentation package.

ü  Guaranteed Purified Water quality, according to USP, EP,  WHO.

ü  FAT (Factory Acceptance Test) carried out in the presence  of the customer.

ü  Superior quality with on time  delivery.

With various combinations depending upon the water quality  and end water requirements technology options are tailored with required  automation

Standard Systems include:

ü  Raw water reserve tank

ü  Chlorine dosing system

ü  Multimedia Filter

ü  Activated Carbon Filter/ Sodium Bisulfite  Injection

ü  Automatic Softener(Duplex)/ antiscaling Scaling  system

ü  Break tank

ü  Micro filter

ü  NaOH dosing system for pH adjustment

ü  RO  System

ü  Continuous Electrodeionization  System

ü  Touch screen Operator Interface

ü  Ethernet Communications

Optional features include:

ü  Chemical/hot  water sanitization process

ü  Pre/Post-Treatment UV Disinfection

ü  Degasification

ü  Post-Treatment Ultrafiltration

ü  21  CFR Part 11 Compliant Record-Keeping

ü  SCADA

ü  One stop solution for complete Purified Water Generation;  Storage & Distribution System.

ü  Total Organic  Carbon (TOC) Monitoring

Documentation package for  offer

1.          Drawings 

Mechanical drawings      

Equipment location drawings

Installation drawings   

Dimensioned drawings   

Foundation and steel construction  drawings

Final P&I Diagrams

2.          Lists

Lists of all equipment, components and  instruments

Tag number, supplier, type, dimensions of connections,  material,   

Pressure classification, crosslink to material certificate  if component are in contact with product or clean utility.

A complete spare parts list both for mechanical and  electrical components/control system.

3.          Certificates

Material certificates for all product-wetted metallic  parts.

Material certificates/statements for all product-wetted  non-metallic parts

Certificates and/or measurement protocols for surface  finish for all product wetted metallic parts

Declaration of conformity/CE  certificate

Noise level certificate/measurement  protocol

Calibration certificates

4.          Welding  Documentation

Welder certificates, for hygienic  piping.

Welding logbook (welding data, visual  inspection).

Welding identification maps.

X-ray test logbook on 10 % of welds.

Borescope test logbook on 20 % of  welds.

Passivation  certificate.

Pressure vessel  certificate.

Welding procedure specification.

5.          Electrical & Control  Documentation

Single line drawings for electrical  distribution

Circuit diagrams

Coupling diagrams

Layout drawings for main distribution cabinet  etc

Cable list

Equipment location drawings for electrical equipment and  instruments

Description of software architecture

Programming standard

Commented PC/PLC program in electronic  form

I/O-lists

Alarm list

Back-up copies of application  programs

Description of the application program, preferably by a  flow chart

Software design specification

Functional specifications

Instruction for backup and reload backup  copies

6.          Manuals and Maintenance  Instructions

Operator manual in English

Installation and assembly instructions for all  devices

User’s manuals for all components

Trouble shooting guide

Maintenance and service instructions

Safety instructions English

Training Plan and Training  Documentation

7.          Qualification  Protocols/Reports

DQ protocols and reports

FAT protocols and summary of results  

IQ protocols and reports

OQ protocols and reports

PQ protocols and reports

Key  Words for PW Generation System

Water for Pharmaceutical Use, cGMP Water System, Pharma  Water, US Pharmacopeia, European Pharmacopeia, FDA Water, Chinese Pharmacopeia,  Sanitary Water System

Purified Water, USP PW water, WHO Water, Pure Water,  Highly Purified Water, Reverse Osmosis, Ultra pure water for  Pharmaceutical

PW Generation System, Double Stage RO, Single Stage  RO+EDI, Double Stage RO+EDI, PW distribution system, PW Storage System,  Distribution Loop, Purified Water Validation, Sanitary Piping System, cEDI Water  treatment, Sanitary Piping Installation, Purified Water Piping System,  Pharmaceutical Purified Water Piping