API Manufacturing:
Highlights of the Process adopted to meet our Goal
- Since Oncology APIs are highly potent, a methodology of handling materials in line with requirements of a high-containment facility has been adopted: starting from active RMs & API sampling to dispensing.
- Extensive use of Active/Passive valves at various stages of the process to achieve the objective of high-containment.
- A robust technology transfer from state-of-the-art R&D Centre located at Bhiwadi, Rajasthan.
- An in-house state-of-the-art QC laboratory comprising QC Chemical & QC Microbiology set up at SRL.
- A world-class material storage facility at our Warehouse for APIs / Excipients / Packing Materials / In-Process FG quarantine / FG Store (Area 2000 sq. metres).
API Manufacturing:
API Facility consists of:
- Warehouse
- QC, Microbiology & QA.
- Oncology API manufacturing
- General API manufacturing
- Effluent treatment plant & MEE Plant
- Utility
- Boiler
- Purified Water plant
- Nitrogen Plant
- Process Chilling Plant
- Brine Plant
- Cleanroom HVAC
Ensuring Total Absence of Cross Contamination
Manpower:
- Dedicated manpower for oncology & non oncology API production.
- Entry controls in production blocks such as allowing only authorized personnel.
- Adequate training by QA to personnel of Production, QC, Engineering and other Departments to prevent cross-contamination.
Facility:
- In oncology production facility, air showers provided for entry & exit of personnel.
- Different gowning procedure provided for oncology & non-oncology production facilities.
- For oncology products manufacturing, facility provided for material isolation inside the isolators.
- Uni-directional movement of men & materials to avoid the cross contamination.
- Dedicated production blocks for oncology & non-oncology products.
- Dedicated QC labs provision for analysis of oncology & non-oncology products.
- Detoxification of tools & samplers/waste in oncology production facility.
- Dedicated vacuum systems available for oncology & non-oncology production facilities.
- Dedicated storage facility for oncology & non-oncology APIs in warehouse.
- Environmental monitoring for oncology & non-oncology production facilities
