Customized Hvac system for pharmaceutical clean rooms
In environments where precise control of air quality and sterilization is crucial, maintaining strict compliance with international standards is a significant challenge. This is especially true for pharmaceutical, biological, and medical equipment engineering, where any contamination can compromise product purity and safety.
Ensure compliance with Iso14644 and Pda Tr13 standards
The customized HVAC system by Austar is tailored for various types of workshops, including those in chemical preparation, biological product engineering, and medical equipment engineering. This system meets the stringent requirements of ISO14644 and PDA TR13 standards. Integrated features include a VHP space sterilization system, dust particle online monitoring, floating bacteria monitoring, and energy efficiency analysis. The system supports computerized system confirmation and validation documents, ISPE commissioning, validation documents, electronic records, and electrical signatures as per CFR title 21 Part 11 ERES. Additionally, it integrates BMS/EMS intelligent control systems for efficient and effective operations.
Benefits
- Comprehensive monitoring and control
- Full compliance with multiple international standards
- High level of automation
- Energy-efficient operations
- Detailed validation documentation included