Manufacturing Infrastructure::Facility
To keep the pace with today’s requirements of the pharmaceutical industry, we have adopted the most modern & sophisticated Aseptic Blow – Fill – Seal technology. ISO certified & cGMP compliant facilities of Marck can handle manufacturing & packaging of Sterile Liquid Parenterals from 5 ml to 1000 ml.
Spread over 25 acres of land area near Kheda (Ahmedabad), our manufacturing operations are supported by most modern equipments, state – of – art Quality Control and F & D capabilities.
With a total construction area of 19,000 sq mts, our state – of – art manufacturing complex with following features gives us a competitive edge:
- Aseptic Blow Fill Seal technology from Renowned manufacturer’s like Weiler Eng.(USA) and Rommelag (Germany) with Nitrogen blowing facility for sensitive drugs manufacturing
- Clean rooms are made-up of prefabricated panels from Clestra France
- Manufacturing is in Grade “B” area and all vessels have chilling and sterilizing facility to facilitate manufacturing of various combinations of drug in clear as well as suspension form
- Filling is under grade “A” area having continuous particle monitoring with a background of grade “C”
- UPS for filling LFR on all BFS machines
- Terminal Sterilization of products by ‘Super Heated Water Spray Sterilizer”
- Entire process is controlled by “SCADA” system
- Automated packing lines having 100% leak detection system
We have most modern systems to support our entire manufacturing process:
WATER SYSTEMS
- Double pass RO system coupled with EDI+UV and UF for generation of high grade purified water followed by distillation process for generation of SWFI
- Continuous recording system for WFI temperature, conductivity and velocity in loop
ENVIRONMENTAL CONTROL SYSTEMS
- Separate AHU system for each of the activities
- All classified rooms entry has bio-metric access control. All man and material entries to the plants are interlocked and material entries are sealed with dynamic LAF