Active Pharma
Ingredients - API

SHIVALIK RASAYAN LIMITED

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.

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).

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

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)

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)

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.

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.