Active Pharma
Ingredients - API
API Manufacturing
SHIVALIK RASAYAN LIMITED
A State-Of-The-Art API Manufacturing Facility at Dahej
- Designed to be a dedicated, state-of-the-art facility for the manufacturing General APIs & Oncology APIs.
- Aimed to comply with requirements of highly regulated markets, and, to maintain the same level of cGMP commitment through entire operation
- Plant located on a sprawling area of 50,000 sq. metres including all production blocks & other buildings & Utilities
- Four Onco and Four Non-Onco dedicated blocks are planned.
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 Facility consists of:
- Warehouse
- QC, Microbiology & QA.
- Oncology API manufacturing
- General API manufacturing
- Utility
- Boiler
- Purified Water plant
- Nitrogen Plant.
- Process Chilling Plant
- Brine Plant
- Cleanroom HVAC
- Effluent treatment plant & MEE Plant.
Equipment - Concept for Oncology & General APIs
- Capacity of 8 Production Blocks (Minimum batch size 200 gm & maximum 300 Kg) with flexibility of handling different batch sizes.
- In 1st Phase
- Batch size of 10 Kg Oncology APIs facility is being commissioned.
- Batch size of 25 Kg General APIs facility is being commissioned.
- Design-basis for Oncology APIs:
- Glass Lined Reactors for acidic Reaction.
- Separate rooms for Centrifuging & Drying.
- Containment technology Isolators for handling Active Oncology Products.
- Cleanroom Partition for Pharma Production.
- Cleanroom HVAC Class D Classification for Pharma Production.
- Centralized Comfort conditioning for Intermediate production.
- Dedicated AHUs for Powder handling in Intermediate Production for separate Production lines
Production Areas
Oncology API manufacturing section :
- RO1 Block : 895 Sqm (Production Block – Validation batches planned in early December 2019)
- RO2 Block : 1185 Sqm (Proposed Production Block – Constructed Area)
- RO3 Block : 1550 Sqm (Proposed Production Block – Constructed Area)
- RO4 Block : 2055 Sqm (Proposed Production Block – Constructed up to Plinth Beam)
General API manufacturing section :
- Capacity of 8 Production Blocks (Minimum batch size 200 gm & maximum 300 Kg) with flexibility of handling different batch sizes.
- RG1 Block : 1080 Sqm (Production Block – Validation batches planned in early December 2019)
- RG2 Block : 1725 Sqm (Proposed Production Block – Constructed Area)
- RG3 Block : 1850 Sqm (Proposed Production Block – Constructed Area)
- RG4 Block : 1925 Sqm (Proposed Production Block – Constructed up to Plinth beam)
Effluent Treatment Plant :
Zero Discharge Facility
- Technology: Multi Effect Evaporator
- Capacity : 50 KL effluent /24hrs
- Treated Water : Used for gardening
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.