Business Unit
API Manufacturing
Highlights of the process adopted to meet our goal of world-class API production with zero cross-contamination.
API Facility
Our API manufacturing facility is designed and operated to support both oncology and non-oncology production with dedicated infrastructure, equipment and quality systems.
Ensuring Total Absence of Cross Contamination
Manpower
- Cleanroom HVAC
- Dedicated manpower for oncology & non-oncology API production
- Entry controls in production blocks — only authorized personnel
- Adequate training by QA to personnel of Production, QC, Engineering and other Departments to prevent cross-contamination
Facility
- Air showers for entry & exit of personnel in oncology production facility
- Different gowning procedure for oncology & non-oncology production facilities
- Material isolation inside isolators for oncology products manufacturing
- Uni-directional movement of men & materials to avoid cross contamination
- Dedicated production blocks for oncology & non-oncology products
- Dedicated QC labs for analysis of oncology & non-oncology products
- Detoxification of tools & samplers/waste in oncology production facility
- Dedicated vacuum systems for oncology & non-oncology production facilities
- Dedicated storage facility for oncology & non-oncology APIs in warehouse
- Environmental monitoring for oncology & non-oncology production facilities
