Salient Feature
- Facility designed with latest WHO GMP Zoning concept
- Unidirectinal Process Flow and Pressure cascade introduced to avoid mix-up & cross-contamination.
- Automatic BMS system with 21 CFR part 11 compliant installed for monitoring and recording of all critical clean room GMP parameters
- Automatic VHP decontamination system introduced for aseptic operation
- Automatic CIP & SIP systemintroduced in case of critical Machine cleaning.
- Double HEPA Filters with 99.999 introduced in Class B & C Areas
- RABS (Restricted Access Barrier System) introduced with all Machinery for Aseptic operations
- SCADA and online TOC Analyzer introduced with PW, WFI & Clean steam generation.
- High Voltage Leak Tester & Automatic Inspection M/C installed
- BSL 2 safety cabinet installed in microbiological Testing labs.
- Dedicated utilities installed to Supply Sterile unit only.
