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Industrial Process Requirements

A Hi-Purity Water System produces water of exceptional quality — free from ions, microorganisms, endotoxins and particulates. In pharmaceutical manufacturing, it is mandatory to meet cGMP, WHO, USP, and European Pharmacopoeia regulatory standards. The three primary grades are Purified Water (PW), Highly Purified Water (HPW), and Water for Injection (WFI). Process Pulse designs and installs all three types of systems across Gujarat and India.

RO (Reverse Osmosis) removes 95–99% of dissolved solids using a semi-permeable membrane. EDI (Electrodeionisation) polishes RO water further using ion-exchange resin and an electric current to achieve conductivity below 0.1 µS/cm. WFI (Water for Injection) is the highest purity grade — produced by multi-effect distillation or membrane filtration — and is used directly in injectable drug manufacturing. Process Pulse provides all three as standalone or integrated turnkey solutions with complete validation documentation.

Yes. We provide complete validation documentation packages — Design Qualification (DQ), Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) — prepared in accordance with USFDA 21 CFR Part 211, WHO Technical Report 970, EU GMP Annex 1, and India's revised Schedule M guidelines. Our documentation is audit-ready and has been accepted by USFDA, MHRA, and WHO pre-qualification auditors.

Process Pulse serves pharmaceutical companies, API manufacturers, biotechnology firms, chemical plants, food & beverage producers, healthcare facilities, and aerospace industries. Our projects span across Gujarat (Vadodara, Ahmedabad, Surat, Ankleshwar, Halol), Maharashtra (Mumbai, Pune, Nashik), Rajasthan, and other pan-India locations. We are the preferred partner for companies in the Gujarat Industrial Corridor, Makarpura GIDC, and Halol GIDC.

Timelines depend on system complexity: a basic RO+MIXBED system (100–500 LPH) takes 4–6 weeks from order to commissioning. A complete RO+EDI system takes 6–10 weeks. A full WFI generation and distribution system takes 12–20 weeks. Turnkey projects with multiple systems and full validation typically take 6–12 months. We provide detailed project schedules with milestone-based delivery commitments for all projects.

Process Pulse systems are designed and built to comply with: cGMP (Current Good Manufacturing Practice), WHO TRS 970 (Water Systems for Pharmaceutical Use), USFDA 21 CFR Part 211, USP <1231> (Water for Pharmaceutical Purposes), European Pharmacopoeia (EP) 2.2.3, ASME BPE (Bioprocessing Equipment), ISO 9001:2015, and India Schedule M (Revised). Our projects have passed USFDA, MHRA, WHO, and DCGI regulatory audits.