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Manufacturing

Escientia operates a truly state-of-the-art cGMP manufacturing facility at Vishakhapatnam, Andhra Pradesh. It is a multipurpose facility ideally suited for NCE CDMO requirements and operates to OEL levels of up to 10microgram/m³. Starting from a Kilo Lab, Pilot Plant, and then three different scale commercial-scale production suites enable us to operate at kilo scale to ton scale. Moreover, the DCS system controls operating parameters within defined ranges to ensure robust and high quality manufacturing operations.

The facility is supported by a team of scientists and process engineers to ensure robust technology absorption and transfer into production. We have a very experienced technical team which delivers quality and productivity while ensuring process safety and a utmost care for the environment.

This facility has state of art quality control department equipped with all modern analytical equipment controlled by 21 CFR part 11 software i.e. Chromeleon, Empower, and LC solution.

The manufacturing facility can carry out a wide range of chemical reactions which make it ideally suited for longer and complex NCE synthetic routes.

Furthermore it has been designed to withstand natural calamities like cyclones and earthquakes. It has a well designed fire hydrant system with a water sprinkler system. The facility has an alcohol resistant film forming foam system at the solvent tank farm.

Our manufacturing procedures/specifications:

  • DOEs to define critical process parameters
  • In-house testing, release of raw materials, and packing materials
  •  Kilo-lab for scalability and robustness demos
  • Long-term supply-chain strategies
  • Dedicated areas for wet analysis and instrumentation (HPLC, GPLC, and GC)
  • Instrument compliance with 21 CFR Part 11 regulations
  • Analytical instrumentation powered by Waters Empower 3 networking system
  • Stability testing per ICH guidelines (accelerated, long-term, intermediate and zone IVB)
  • Pneumatic powder transfer handling system and through IBCs
  • Mix of SS, GL and Hastelloy reactors
  • High Pressure Manufacturing
  • Cryogenic Manufacturing (-78°C)
  • Filters (peeler centrifuges, ECTFE coated)
  • Driers (RCVD, ANFD, VTD)
  • Powder processing areas includes Micronizer, Multi Mill, Co-Mill, Sifter and Homogenizer
Scientist and large piece of intricate equipment

Our core strengths that aid the manufacturing process:

  • Process Engineering
  • Handle Hazardous Reactions
  • Flow Chemistry (Currently in R&D)
  • Closed material handling system for solids and solvents
  • Single fluid heating/cooling system with operating temperatures at -20°C to +140°C
  • Process automation through DCS and PLCs
  • Process equipment handling under inert atmosphere
  • Cleaning in-place through spray ball
  • Flexible modular plant design for quick change overs
  • ISO class 8 clean rooms

Manufacturing Support Functions – Warehouse

  • Uni-directional material flow
  • Separated storage facility for highly-potent compounds
  • FM Global-compliant: smoke detectors, sprinklers, fire hydrant systems all over storage areas
  • Dedicated storage area for:

Gas cylinders, acids, bases, catalysts, carbon, packaging materials, bulk solvents and drums. Finished goods, raw materials and finished goods stored according to their temperature requirements in areas NMT 25°C, 2-8°C, and -20 °C. Sampling and dispensing will be done under reverse laminar air flow (RLAF) booth.

Scientist in blue PPE inspecting pipes