Tofflon is making important investments in advanced innovations, facility expansion and organisation restructuring
Shanghai Tofflon Science & Technology Co, the global manufacturer of largest freeze drying system, has done more than 3500 freeze drying system projects across 50 countries and regions. Tofflon believes that automation, isolation, and system integration are becoming the main stream for aseptic processing of sterile manufacturing.
Since the last few years, Tofflon has been able to understand sterile manufacturing regulatory requirements and stringent pharmaceutical guidelines. The company provides complete upstream and downstream machines for freeze drying system. It focuses on mechanical integration with upstream and downstream equipment as well as complete process automation integration so as to achieve uninterrupted and consistent process establishment to continuously improve drug quality and production efficiency. Recently, Tofflon has completed injectable line project in Shilpa Medicare, Hyderabad.
Project overview
Shilpa Medicare, Hyderabad Jadcherla unit is a world-class finished dosage manufacturing facility, spread over 36414 sq metres and is located around 70 kms from Hyderabad international airport. The unit is planned for carrying contract manufacturing and dosage developments, designed to meet cGMP, USFDA, EUGMP, TGA, MHRA, PMDA and all other regulatory requirements. The facility has dedicated oncology injectable block and consists of liquid/ lyophilised injectable commercial scale manufacturing line with 120 vials/ min capacity and dry powder vial filling line 50 vials/ min capacity.
All major crucial and assisting machineries for injectable manufacturing is supplied by Tofflon. Crucial machines like auto solution preparation tanks, vial filling line, freeze dryer, auto loading system and dry powder vial filling line and assisting machines like autoclaves, external vial washer etc, are provided by Tofflon.
Project challenges
- It is a systematic automatic project in compliance with USFDA and other regulatory standards
- All critical machines should be in the same platform and integrated with each other
- All systems are data integrated, centrally controlled and monitored
- It is oncology injectable unit. The product OEL (operator exposure limit) is four and above grade, hence complete isolation of product from contamination and operator safety is required.
Project solutions
Complete automation is incorporated in all sterile processing machines to avoid human intervention as much as possible to avoid cross contamination as per GAMP 4. All the machines are manufactured considering plant layout, functionality and safety and harmonic ensemble to improve production efficiency.
All sterile processing machines are laid down in linear fashion in the same platform such as autoclaves, vial washing, sterilising tunnel, solution preparation tanks, aseptic filling, freeze dryer and auto loading and unloading, capping and labelling. The machines are set up in such way that the space needed for the highest clean room class is optimised and increased the employee’s productivity.
All the systems are interconnected with central SCADA system to monitor batch record and data and are made easy in data review during audits. Since all the equipment is from a single supplier, it is much easy for the system and data integration compared to different machines from different manufacturers.
Since it is oncology injectable manufacturing plant, integrated pass-through designs are provided so that materials can always be moved from one production stage to next stage with most efficient route and personal safety. By minimising the movement of materials and personnel in sterile facility, it helps to eliminate end product contaminations. Complete line is incorporated with isolators to maintain Class A area inside the filling line and class B grade in the room.
Contact Details:
Tofflon India
6th Main, 2nd Cross,
Tayappa Garden
Bilekahalli,
Bangalore – 560076
Email: [email protected]
Website: www.tofflon.com
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