DESIGN QUALIFICATION (DQ) OF PURIFIED WATER GENERATION SYSTEM
1.0 INTRODUCTION : Design Qualification (DQ) is a documented verification that the proposed design of the Purified Water Generation System complies with the User Requirement Specification (URS), cGMP guidelines, and applicable regulatory standards.
This document demonstrates that the system designed ,suitable for producing purified water meeting pharmacopoeial standards (USP) and client requirements. The design considers raw water quality, potential contaminants, and their impact on downstream purification processes.
2.0 OBJECTIVE
The objective of this Design Qualification is to:
- Verify that the system design meets the URS requirements
- Ensure compliance with cGMP guidelines
- Confirm that the system can consistently produce purified water meeting defined quality standards
- Provide a documented basis for further validation activities (IQ, OQ, PQ)
3.0 SCOPE
This DQ applies to the complete Purified Water Generation System installed at the client site in Baddi. It includes:
- Pre-treatment system
- Reverse Osmosis (RO) system
- Electro Deionization (EDI) system
- Post-treatment and distribution interface
- Instrumentation, automation, and control system
4.0 RESPONSIBILITY
4.1 Vendor
- Design system as per URS and regulatory standards
- Provide technical documents (P&ID, GA drawings, specifications)
- Ensure compliance of equipment and components
- Provide training to client personnel
4.2 Client
- Review and approve design documents
- Provide utilities and site readiness
- Ensure proper installation environment
- Support commissioning and validation activities
5.0 BASIS OF SYSTEM DESIGN
5.1 Raw Water Analysis
The system is designed based on provided raw water characteristics including:
- TDS: ~262.9 mg/L
- Hardness: ~193.82 mg/L
- pH: ~7.08
- Microbial limits: Within acceptable range
5.2 Output Requirements
- Capacity: 2000 LPH
- Water Quality (USP):
- Conductivity: < 1.3 µS/cm
- TOC: < 500 ppb
- Microbial count: < 100 CFU/mL
- pH: 5.0 – 7.0
5.3 Design Flow Rates
| Stage | Inlet (m³/hr) | Outlet (m³/hr) |
|---|---|---|
| MGF | 4.5 | 4.5 |
| Softener | 4.5 | 4.5 |
| CSRO | 4.5 | 3.0 |
| HSRO | 3.0 | 2.2 |
| EDI | 2.2 | 2.0 |
6.0 BASIC TREATMENT SCHEME
The system consists of the following stages:
- NaOCl Dosing
- Multi Grade Filter (MGF)
- Softener
- Antiscalant Dosing
- SMBS Dosing
- pH Correction
- CSRO System
- Hydro Pneumatic System
- HSRO System
- EDI System
- CIP System
Salient Features
- Fully automated operation
- Continuous water supply
- Critical parameter monitoring
- Alarm and interlock system
DESIGN QUALIFICATION (DQ) WFI STORAGE & DISTRIBUTION SYSTEM
7.0 TECHNICAL SPECIFICATIONS
7.1 Equipment
Major equipment includes:
- Dosing tanks and pumps
- Multi-grade filter (FRP)
- Softener (Ion exchange resin-based)
- RO systems (CSRO & HSRO)
- EDI module
- CIP system
- Storage tanks (HDPE / SS316L)
7.2 Instruments
- Flow meters and switches
- Pressure gauges and transmitters
- Conductivity sensors
- pH and ORP sensors
- Level transmitters
- Temperature sensors
7.3 Valves
- Ball valves (manual & actuated)
- Diaphragm valves
- Non-return valves
- Sampling valves
- Safety valves
All materials of construction are selected to ensure compatibility, durability, and GMP compliance.
8.0 DOSING CALCULATIONS
| Chemical | Dosage Flow | Daily Consumption |
|---|---|---|
| NaOCl | 1.93 LPH | 5.4 kg/day |
| Antiscalant | 1.93 LPH | 0.65 kg/day |
| SMBS | 1.93 LPH | 1.0 kg/day |
| NaOH | 1.93 LPH | 2.18 kg/day |
9.0 CONTROL PANEL DESCRIPTION
- PLC-based automated control system
- HMI interface for operation and monitoring
- IP-54/55 stainless steel enclosure
- Password-protected access (4 levels)
- Alarm system and event logging
- Compliance with electrical standards
10.0 AUTOMATION
- PLC: Siemens S7-1200
- HMI: Siemens KTP Series
- VFD: Siemens SINAMICS
- Fully automated process control
- Real-time monitoring and feedback
11.0 DOCUMENTATION
The following documents will be provided:
- P&ID
- GA drawings
- Equipment layout
- DQ, IQ, OQ protocols
- Calibration certificates
- Manuals and SOPs
- FAT documents
12.0 PANEL INTERLOCKS AND OPERATIONAL LOGICS
System includes safety interlocks such as:
- Low/high tank level protection
- High pressure trip
- High conductivity rejection
- Flow failure shutdown
- Emergency stop
- Power failure protection
All alarms are categorized as Critical (C) or Monitoring (M).
13.0 UTILITY REQUIREMENTS
| Utility | Specification |
|---|---|
| Feed Water | 4500 LPH |
| Power Supply | 415V, 3 Phase |
| Steam | 45 kg/hr |
| Compressed Air | 6–8 kg/cm² |
| Chemicals | NaOCl, SMBS, NaOH, Antiscalant |
14.0 ENCLOSURES
- P&ID Drawing
- Tank Drawings
- Layout Drawings
Summary
The Purified Water Generation System has been designed based on the client’s URS, raw water analysis, and regulatory requirements. The system incorporates advanced treatment technologies including RO and EDI, along with effective pre-treatment and dosing systems. Automation and control features ensure consistent operation, monitoring, and safety.
The design includes adequate instrumentation, interlocks, and alarms to maintain critical process parameters within defined limits.
Conclusion
The design of the Purified Water Generation System is found to be suitable and compliant with cGMP and USP requirements. It is capable of producing purified water meeting specified quality standards consistently.
The system design is approved for further stages of qualification, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).