ELGA PURELAB Pharma Compliance Ultra-Pure Water System
| Brand | ELGA (Veolia) |
|---|---|
| Origin | United Kingdom |
| Manufacturer Type | Original Equipment Manufacturer (OEM) |
| Origin Category | Imported |
| Model | PURELAB Pharma Compliance |
| Pure Water Grade | ASTM Type I / ISO 3696 Grade 1 |
| Resistivity | 18.2 MΩ·cm at 25 °C |
| Total Organic Carbon (TOC) | 1–3 ppb |
| Microbial Count | <0.001 CFU/mL |
| Endotoxin Level | <0.001 EU/mL |
| Particulates (>0.1 µm) | <0.01 particles/mL |
| Compliance | USP <643>, USP <645>, EP 2.2.44, ISO 13485, ISO 9001, GMP Annex 1, FDA 21 CFR Part 11 (audit trail enabled), GAMP 5, ISPE Good Practice Guides |
Overview
The ELGA PURELAB Pharma Compliance Ultra-Pure Water System is an engineered solution for regulated pharmaceutical and biotechnology laboratories requiring continuous supply of water meeting stringent pharmacopoeial and regulatory specifications. Designed in accordance with the principles of Good Manufacturing Practice (GMP), this system employs a multi-stage purification architecture—including reverse osmosis, electrodeionization (EDI), dual-wavelength UV oxidation (185/254 nm), ultrafiltration, and final polishing via integrated 0.1 µm membrane filtration—to consistently deliver Type I ultrapure water compliant with USP (TOC), USP (conductivity/resistivity), European Pharmacopoeia 2.2.44, and ISO 3696 Grade 1. Its closed-loop distribution design minimizes microbial ingress and biofilm formation, while real-time monitoring of resistivity, TOC, temperature, flow rate, and pressure ensures continuous verification of water quality throughout the point-of-use cycle.
Key Features
- Integrated, validated hardware architecture supporting full GMP lifecycle management—from qualification (DQ/IQ/OQ/PQ) through routine operation and periodic requalification.
- Touchscreen HMI with role-based access control (RBAC), password-protected user levels, and configurable audit trail logging compliant with FDA 21 CFR Part 11 requirements.
- Dual-wavelength UV oxidation (185 nm + 254 nm) for effective TOC reduction and microbial inactivation without chemical residuals.
- Endotoxin-retentive ultrafiltration cartridge (<0.001 EU/mL output) and low-particulate (0.1 µm) final polish stage optimized for cell culture, HPLC mobile phase preparation, and molecular biology applications.
- Modular footprint designed for benchtop integration or under-bench installation; compatible with centralized distribution loops and point-of-use dispensing arms.
- Pre-certified validation documentation package including FAT/SAT protocols, IQ/OQ templates, calibration certificates, and material traceability records aligned with ISO 13485 and GAMP 5 guidelines.
Sample Compatibility & Compliance
The PURELAB Pharma Compliance system is intended for production of water for injection (WFI)-grade equivalent water used in non-sterile pharmaceutical manufacturing support processes—including analytical testing (HPLC, GC-MS, ICP-MS), buffer preparation, reagent dilution, and cleanroom surface rinsing. It meets or exceeds the performance criteria defined in USP , EP 2.6.12, and JP 17 for purified water and ultrapure water applications. All wetted materials comply with USP Class VI biocompatibility standards and FDA-listed food-contact regulations. System design supports ALCOA+ data integrity principles, with electronic signatures, time-stamped event logs, and immutable audit trails suitable for regulatory inspections by EMA, FDA, PMDA, and Health Canada.
Software & Data Management
The embedded ELGA Connect™ software provides secure, browser-based remote monitoring and configuration via encrypted HTTPS. It supports automated report generation (PDF/CSV), configurable alarm thresholds, trend analysis of critical parameters (resistivity, TOC, UV intensity), and export of raw data for LIMS integration. All system events—including filter change alerts, UV lamp life tracking, and maintenance history—are recorded with user ID, timestamp, and action description. Software validation packages include IQ/OQ documentation, traceability matrices, and test scripts aligned with GAMP 5 Annex A and ICH GCP standards. Optional 21 CFR Part 11 compliance mode enables electronic signature workflows and role-defined permission sets.
Applications
- QC/QA laboratories performing compendial testing per USP, EP, or JP monographs
- HPLC and UHPLC mobile phase preparation requiring sub-ppb TOC and low ionic background
- Cell culture media formulation where endotoxin and nuclease contamination must be minimized
- Mass spectrometry sample dilution and instrument rinse solutions
- GMP-compliant environmental monitoring water for swab/rinse recovery studies
- Calibration standard preparation for trace metal analysis (ICP-MS, AAS)
FAQ
Does the PURELAB Pharma Compliance system support full 21 CFR Part 11 compliance out of the box?
Yes—when configured in Part 11 mode, it enforces electronic signatures, audit trail retention for ≥36 months, and role-based access controls validated per GAMP 5.
Can the system be integrated into an existing laboratory network with LIMS or MES?
Yes—it offers OPC UA and RESTful API interfaces for bidirectional data exchange with major LIMS platforms and enterprise systems.
What validation documentation is included with shipment?
A complete GMP-ready validation toolkit is supplied, including DQ templates, FAT/SAT reports, IQ/OQ protocol drafts, calibration certificates, and material compliance declarations.
How frequently must consumables be replaced to maintain compliance?
Filter and cartridge replacement intervals are dynamically calculated based on usage metrics and logged automatically; typical service cycles range from 6–12 months depending on feed water quality and daily throughput.
Is remote diagnostics and service support available globally?
Yes—ELGA’s global service network provides remote troubleshooting, predictive maintenance alerts, and on-site engineer dispatch within SLA-defined response windows across EMEA, North America, and APAC regions.
