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감사를 받은 공급업체 독립적인 제3자 검사 기관의 감사를 받음
PW/WFI Storage & Distribution System
GMP-Compliant, Intelligent Fluid Management Engineered for Pharma Excellence
Key Innovations & Competitive Advantages
Modular Agile Architecture, Lifecycle-Optimized Performance
▸ Space-Smart Design: Pre-engineered modular configuration increases spatial efficiency by 40%, enabling seamless integration into dynamic facility layouts.
▸ Rapid Deployment & Maintenance: Clamp-and-go assembly reduces installation time by 50%, with ergonomic access points enabling in-line component replacement (downtime reduced by 70%).
▸ Material Superiority: Constructed with 316L SS/EP-grade polymers, featuring electropolished surfaces (Ra ≤0.6μm), fully compliant with ASME BPE-2022 and FDA 21 CFR 211.
AI-Driven Energy Optimization, GMP-Compliant Flow Dynamics
▸ Smart Frequency Conversion: AI-optimized variable-speed circulation pumps maintain turbulent flow (0.5-3 m/s ±5% tolerance), reducing energy consumption by 30% while ensuring ISPE Water & Steam Systems compliance.
▸ Real-Time Quality Assurance: Multi-point monitoring of TOC (<500 ppb), conductivity (≤1.3 μS/cm), and temperature (±0.5°C), with 3D hydraulic modeling aligned with USP <1231> standards.
Fully Automated CIP/SIP Validation, Zero-Dead-Zone Sterility Assurance
▸ 4D Spray Ball Coverage: Validated cleaning efficiency ≥99.9% per PDA TR29, with dual-PLC synchronized control for repeatable cycle reproducibility.
▸ SIP Excellence: Phase-controlled saturated steam sterilization with auto-F0 value calculation (≥15 mins), integrated bio-indicator challenge test protocols.
Multi-Fluid Integrated Platform, Scalable Process Ecosystem
▸ Unified Media Management: Simultaneous handling of PW/WFI/Pure Steam/Process Gases (N2/Compressed Air) with ±0.5% pressure control accuracy, eliminating cross-contamination risks.
▸ PAT Integration: Optional real-time O2/CO2/particulate monitoring modules, with data directly interfacing with MES/SCADA via OPC-UA protocol.
Industry 4.0-Ready Intelligent Control Platform
▸ 21 CFR Part 11-Compliant SCADA: Auto-generated electronic batch records with full audit trails, covering 100% operational events.
▸ Predictive Maintenance 2.0: IoT-enabled failure forecasting reduces MTTR to <2hrs via AR-guided troubleshooting, achieving ≥99.5% annual uptime.
▸ Global Compliance Assurance: Preloaded templates for FDA/EMA/WHO audit documentation, with automatic update alerts for evolving pharmacopeia standards.
Strategic Value Proposition
1.35% Faster Project Delivery: Pre-validated skid modules + on-site plug-and-play commissioning
2.Turnkey 4Q Validation: Full DQ/IQ/OQ/PQ packages with risk-based FAT/SAT protocols
3.24/7 Global Support: 48-hour critical spare parts dispatch across 50+ countries
4.Lifecycle Cost Savings: 25% reduction in TCO through predictive maintenance and energy optimization
Target Applications
Biologics Fill-Finish | Vaccine Production | CGT Facilities | Large-Volume Parenteral Lines | API Synthesis
Trusted by 200+ GMP-certified manufacturers worldwide, our system empowers pharma 4.0 transformation with:
✓ Zero 483 Observations in recent FDA inspections
✓ 30% Faster Batch Release via paperless operations
✓ 21% Lower Energy Costs versus legacy systems
