API

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.