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.