Salient Features
- The facility is designed in compliance with USFDA/EU/ICH cGMP
guidelines with fully equipped QC Laboratory & Stability units
- Quality by Design principles adopted to minimize risk
- Dedicated entry, exit of Vial, Ampoule, and PFS lines
- Independent entry/exit of personnel for Vial and Ampoule lines
- Separate equipment like Autoclaves, AHUs for Vial and Ampoule lines
- 21 CFR PART 11 COMPLIANT WATER SYSTEM
- 21 CFR PART 11 Compliant FULLY AUTOMACTIC one touch operation
for batch manufacturing
- Eurovent certified AHU's monitored & controlled by fully automatic
EMS
- All machinery with CIP & SIP system
- All filling machinery SCADA controlled & 21 CFR PART 11 compliant
- Online non-viable particle monitoring
- Fully equipped QC and Microbiology Lab with HPLC,GC
Salient Features OF WATER SYSTEM
- PLC controlled purified water & WFI storage and distribution skid.
- 21 CFR PART 11 Compliance.
- Storage tank with Level transmitter, Temperature Transmitter, Inside Spray Ball.
- Pump VFD control to maintain return flow & Velocity.
- Online Conductivity meter, Temperature Transmitter, Flow meter, Velocity meter
and TOC Meter.
- Auto Hot water/steam sanitization facility.
- Continuous Circulation at 80 degrees celsius
- Zero Dead Leg Valve at User points with sampling provision.
- Autoclaves from MachinFabrik
- Auto dumping valves.
Salient Features OF HVAC
- FLAKTGROUP Make Eurovent Certified Air Handling Units.
- P(differential pressure) monitoring across Pre and Fine filters..
- Volume control dampers at return duct.
- Temperature , RH Sensor and Differential pressure transmitter for automatic controlling.
- Environment management system - EMS for monitoring HVAC parameters.
- Treated Fresh air feed for AHUs to meet fresh air requirement.
- 10 micron, controlled ventilation system in Service area.
- Audio video alarm in critical Clean rooms.
- The facility is divided into Grade A, B, C, D areas for specific operations and cleanroom
requirements.
