Pharmaceutical water purification system
Ensuring high purity water is essential in pharmaceutical manufacturing for quality control and validation. Challenges include meeting stringent regulatory standards and minimizing contamination to ensure product safety and efficacy.
Maintain regulatory compliance and high purity
The PURELAB Pharma Compliance by Elga LabWater is designed to meet GxP requirements for pharmaceutical quality control. It offers secure software that meets FDA (21 CFR Part 11) and EU (EudraLex Annex 11) standards for digital record keeping. The purification processes fulfill United States Pharmacopeia standards 643 and 645. Supported by a global network of service teams, the system is modular and stackable, making it space-efficient. It features a daily usage capacity of up to 120 liters and provides 18.2 MΩ.cm resistivity at 25°C. The system minimizes costs and environmental impact by delivering water required to validate drug purity. Consumables are engineered to maintain low operational costs and environmental waste.
Benefits
- Compliant with FDA and EU digital record-keeping standards
- Meets United States Pharmacopeia standards 643 and 645
- Space-efficient modular design
- Low operational and environmental costs
- Global service support for GMP validation