Designed as per the latest regulations, the production department is designed in compliance with regulatory guidelines set by the USFDA/EU-GMP. The architecture and layout enables transparency and smooth man-material transfer.
The manufacturing area houses the Vial Production Lines (Washing Machine, Sterilization & Depyrogenation Tunnel, Filling Machines, Capping Machine, Lyophilizers), Ampoule Production Line (Washing Machine, Sterilization & Depyrogenation Tunnel, Filling & Sealing Machine), Compounding and Filtration Vessels, Pre-Sterilizer/Autoclave, Terminal Sterilizer, Day Stores, Component Washing equipment etc. The manufacturing area is isolated from other areas. All materials and personnel entering into the area are ensured for compliance with CGMP requirements.
Manufacturing takes place in Grade C and the machines are 21 CFR part 11 & GAMP 5 compliant. The filling line is fully integrated with CIP and SIP facility. The entire production department follows the zoning concept enabling transparency and easy control of processes.
Two freeze dryers, 20SQM each, of making Trucking with the provision of automatic loading and unloading systems are also in place.