GreenSignal Bio Pharma Limited operates cGMP manufacturing facilities at its plant in Gummidipooni. The facility is constructed with a sterile filling suite with new HEPA systems, fill line RABs, new WFI system, vial washing depyrogenation capabilities, as well as advanced material and personnel flows
GMP Manufacturing and Aseptic Filling Area
The GMP Manufacturing Facility is approximately 2,500 square feet (232 square meters) and includes separate rooms for the following production functions:
- Personnel Airlock
- Materials/equipment Airlock
- cGMP Suites (2)
- cGMP Aseptic Filling Room
- Autoclave Room
- Equipment/Glass Wash Area
- Vial wash and depryogenation room
- Product Storage Room
The environmental conditions within the GMP Manufacturing Facility, including temperature, humidity, air pressure, and air quality are monitored at regular intervals. Access to the GMP Manufacturing Facility is restricted to authorized personnel and is controlled by an access card system.
Located in the GMP area, this room provides a localized Class B environment for all clean items being removed from the autoclave. The autoclave was installed along with several pieces of process equipment including a pure steam generator, plant steam boiler and a RO/DI purified water system.
GSBPL installed and qualified a new WFI system to support the operational needs of the GMP production areas including the new vial washing and depyrogenation room. The WFI system is compliant with EU requirements.