Pharmaceutical-grade Pw storage and distribution system
In pharmaceutical manufacturing, maintaining the purity and quality of purified water (PW) is critical. Challenges such as contamination risks, system stability, and regulatory compliance must continually be addressed to ensure water quality meets stringent standards.
Ensure stability with multi-mode sterilization
The PW storage and distribution SKID by Austar is a modularly designed system catering to the specific needs of pharmaceutical operations. Notable for its compact structure and user-friendly maintenance, it can be tailored with various sterilization modes including hot water, ozone, pure steam, or 121°C superheated water. High-grade components from globally recognized brands ensure long-term stability. The program adheres to GAMP5 standards, enhancing its reliability and traceability with comprehensive documentation. The system undergoes rigorous verification processes, such as RA, DQ, IQ, and OQ, to ascertain consistent production of quality PW. It also complies fully with FDA cGMP, EU GMP, WHO GMP, and SFDA GMP requirements.
Benefits
- Customizable sterilization modes
- Long-term stable operation with high-quality components
- GAMP5 compliance for enhanced reliability and traceability
- Meets global regulatory standards (FDA, EU, WHO, SFDA GMP)
- Easy maintenance and user-friendly design