Keypack Intelligent Purified Water Generation System (PW System) designed for pharmaceutical-grade water production with cGMP compliance. It delivers high-purity water meeting CP, USP, and EP pharmacopoeia standards through integrated RO EDI technology with intelligent monitoring and energy-efficient operation. Ideal for pharmaceutical manufacturing, biomedical facilities, life science laboratories, and premium cosmetic production lines.
Product Overview
The Pharmaceutical Purified Water System by Keypack Intelligent (Kunbupack) is an advanced modular purified water unit specially developed for pharmaceutical, biomedical, and fine chemical industries. This cGMP compliant water system adopts modular design with core processes including multi-media filtration, softening, activated carbon adsorption, primary and secondary reverse osmosis (RO), and electrodeionization (EDI) technology.
The system features a self-developed intelligent early warning and big data platform that enables smart maintenance and monitoring based on real-time operational data rather than experience-based schedules. Design and manufacturing fully comply with cGMP, FDA, GAMP, and ISPE standards, ensuring water quality chemical purity and microbiological indicators meet CP (Chinese Pharmacopoeia), USP (US Pharmacopoeia), and EP (European Pharmacopoeia) requirements for pharmacopoeia compliance (USP-EP-CP).
The fully automatic online control system enables adjustable water production and circulation for energy-efficient water production, significantly reducing operational costs. The system supports whole or partial online sanitization system capabilities to ensure consistent water quality stability throughout continuous production cycles.
System Configuration
| System Component |
Purified Water System Configuration |
| Pretreatment System |
Multi-media filter, Softener, Activated carbon filter (Optional: Ultrafiltration, Medium pressure UV, Degassing tower) |
| RO System |
Primary RO, Secondary RO (Single-stage or dual-stage configuration available) |
| Deep Purification |
EDI (Electrodeionization) continuous deionization system |
| Control & Monitoring |
Fully automatic control system with online monitoring (Flow, Pressure, Conductivity meters) |
| Disinfection System |
Optional online disinfection (System-level or sub-system) |
| Compliance Standards |
cGMP, FDA, GAMP, ISPE compliant design and manufacturing |
| Water Quality Standards |
Meets CP (Chinese Pharmacopoeia), USP (US Pharmacopoeia), EP (European Pharmacopoeia) requirements |
| Validation Support |
DQ-IQ-OQ documentation and lifecycle support |
Key Features and Machine Characteristics
Intelligent Operation and Maintenance
Self-developed intelligent early warning big data system enables proactive maintenance based on real-time data analytics, reducing downtime and extending equipment lifecycle through predictive maintenance strategies.
Superior Compliance Standards
Design and manufacturing fully comply with cGMP, FDA, GAMP, and ISPE regulatory standards. Water quality chemical purity and microbiological indicators comprehensively meet CP, USP, and EP pharmacopoeia requirements, ensuring regulatory readiness for pharmaceutical applications.
Modular Flexible Configuration
Pretreatment, RO, and EDI modules adopt modular system design, allowing deep optimization based on customer site water source characteristics and actual process requirements. Customized process routes ensure compliance while achieving optimal cost control.
Full Lifecycle Support (DQ-IQ-OQ)
Comprehensive services from design selection, solution optimization, installation and commissioning, validation support (DQ-IQ-OQ documentation), to after-sales maintenance. Complete lifecycle management ensures seamless integration and long-term reliability.
Energy-Efficient and Safe Operation
Fully automatic online control system adjusts water production and circulation to significantly reduce energy consumption. Suspended circuit design separates electrical components from mechanical structure, resulting in lower noise and enhanced operational stability.
High-Standard Hardware Integration
System integrates precision filters, softeners, electrodeionization units, and online monitoring instruments. Advanced engineering ensures reliable performance with minimal maintenance requirements.
Application Areas
Pharmaceutical Manufacturing
Pharmaceutical purified water generation for drug formulation, tablet coating, and injectable preparation. Suitable for oral solid dosage production requiring purified water meeting pharmacopoeia standards.
Biomedical and Life Sciences
High-purity water for IVF laboratories supporting embryo culture media preparation and laboratory equipment cleaning. Provides consistent water quality for sensitive biological applications and cell culture processes.
Hemodialysis Centers
Hemodialysis water treatment for dialysis clinics and renal care facilities. Delivers purified water meeting stringent requirements for patient safety in dialysis applications.
Cosmetic and Personal Care Production
Cosmetic-grade purified water for premium skincare formulation, emulsion preparation, and final product dilution. Supports high-end cosmetic manufacturing with consistent water quality.
Fine Chemical Processing
Process water for fine chemical synthesis, reagent preparation, and analytical laboratory applications. Customizable configurations for specific chemical process requirements.
Mobile and Modular Applications
Available as mobile purified water station for temporary production needs, facility expansions, or multi-site operations requiring flexible water treatment solutions.
Customization and Optional Modules
The RO EDI water system can be tailored based on regional water source characteristics, production capacity requirements, and specific regulatory needs. Optional modules include ultrafiltration pretreatment, medium pressure UV sterilization, degassing towers, and enhanced online sanitization systems. Material options include 316L stainless steel for enhanced corrosion resistance in specific applications.
Delivery and Support
Keypack Intelligent provides comprehensive support including installation and commissioning services, operator training programs, spare parts supply, and warranty coverage. Technical documentation includes complete validation packages supporting regulatory submissions and facility qualifications.
