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