NIPER

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About NIPER

• First national level institute in Pharmaceutical
  sciences.
• Institute of National importance declared by
  govt. of India.
• Imparting higher education carrying out
  advanced research.
• Offer specialized research facilities to industry.

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Functional centre in NIPER

• Central Instrumentation Laboratories.
• Computer center.
• Library and Information centre.
• Central Animal facility.
• National Bio-availability centre.
• Impurity profiling and Stability testing
  laboratory.
• Pharmacological and Toxicological screening
  facilities.
• Technology Development centre.

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NATIONAL INSTITUTE OF PHARMACEUTICAL EDUCATION
AND RESEARCH

• TECHNOLOGY DEVELOPMENT CENTRE

Inaugurated by H.E. THE PRESIDENT OF INDIA
DR. A.P.J. ABDUL KALAM
29 SEPTEMBER 2003
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Technology Development Centre
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TDC for production of APIs.

• Vision of Indian Pharmaceutical Research
  development Committee is
• To provide intellectual capital to make
  available cost effective, contemporary, quality,
  therapeutics to the people of India to reduce
  percentage of mortality and morbidity and to
  emerge as a significant player at global market
  place.
• Against this vision, India has the following
  strength in pharmaceutical technology area
• Major industry with strong manufacturing base
  with capacity to produce quality drugs at lower
  costs.
• Abundance of S T talent and infrastructure.
• Successful experience in innovative process
  chemistry.
• Innovative scientific manpower.
• Self reliant technological base for production.
• Strength of national laboratories.

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Objectives

• NIPER decided to build pilot plants for synthetic
  APIs and herbals to enable
• Scale up all laboratory scale organic chemical
  synthesis/ herbal extractions.
• Generate data/ optimize operating parameters.
• Offer the facilities to SMEs for pilot trials.
• Using it as a training module for postgraduate
  students of NIPER, technical experts deputed for
  short term courses on GMP, environment , safety
  and regulatory authorities.
• Flexibility of operations.
• Safety of operations.

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Objectives

• Compatibility with most unit processes.
• Data logging to monitor reaction progression.
• Generate data for commercial design work.
• Challenging operating parameters for regulatory
  submissions.
• Easy operatability.
• Efficient use of utilities.
• Ability to produce quantities for clinical
  trials.

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Output and Activities

• TDC employed to develop cleaner and newer
  technologies for APIs.
• Equipped to carry out sophisticated reactions
  such as alkylation, condensation, oxidation,
  reduction etc. and related process operations of
  extraction, fractionation, purification,
  isolation, drying etc.
• All effluents (liquid/ solid/ gaseous)
  characterized to develop cost effective
  treatment.
• Utilization of waste material by conversion into
  value added products.

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Facilities available

• Ambient pressure reactions
• Corrosive- glass lined vessels.
• Non corrosive- stainless steel vessels.
• High temperature reactions up to 2500C.
• Cryogenic reactions up to -800C.
• High temperature high vacuum distillations.
• Reactions/ distillations under vacuum.
• High pressure reactions up to 20 Kgs/Cm2.

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Facilities available
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Facilities available

• TDC is having 18 reactors of different sizes,
  agitation profile and MOC
• Post reaction work up facilities such as
  extraction, layer separations, phase separations
  and recoveries.
• Product crystallization.
• Filtration devices like Centrifuge, Nutsche
  filters, Sparkler filters.
• Scrubbers for cleaner environmental conditions.

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Powder handling facilities

• Finished goods area is having HVAC system as per
  GMP requirements
• Drying units as Tray dryer, Vacuum tray dryer,
  Fluidized tray dryer.
• Powder processing.
• Powder Micronisation devices like sifter.
• Blending equipments such as drum blenders.

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Process Control Laboratory

• Provision of in- process monitoring.
• Equipped with HPLC, GLC, TLC systems.
• Provision of Karl-Fischer instrument for moisture
  analysis.
• Well-equipped with Analytical balance, Ultrasonic
  bath, Rotatory evaporator

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Facilities Created

• Safety Systems.
• Nitrogen blanketing for hazardous reactions.
• Protection of vents.
• Isolation of motor control centers.
• Armored electrical cabling.
• Provision of Fire hydrants along the periphery of
  pilot plants.
• Safety measures like use of PPEs being adapted.

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Utility Services

• Steam, 500 kgs/hr at 10kgs/cm2.
• Refrigeration, chilled water plant of 20 TR
  capacity at 50C, chilled brine of 6 TR capacity
  at -200C, cooling tower of 100 TR capacity at
  350C max.
• Vacuum Service at 2-100 torr.
• Compressed air provision for automatic controls.
• Cryogenic temperatures with liquid nitrogen or
  dry ice.
• High temperature system 2500C, max.

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Effluent treatment plant

• Equalizing tank, neutralizing tank, and a
  clarifier for aqueous effluents.
• Incinerator for waste solvents and combustible
  solids.
• Isolated process water streams.

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Auto logging of data

• Relevant parameters such as temperature,
  pressure, pH, fluid flows (steam, chilled water,
  etc) during the reaction get logged during the
  reaction, at predefined intervals in a PC.
• All reactors, columns, heat exchangers and
  process lines provided with RTDs that are further
  connected to scanner.
• Further processing leads to insights into
  reaction and generation of thermodynamic data.

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Control Plan

• All reaction vessels provided with appropriate
  sensors.
• Scanners and PCs at centralized locations.
• Connectivity of equipments to scanner and PC.
• Provision for providing additional sensors as
  required.

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Control Plan

• Temperature and pressure controls at appropriate
  equipments.
• PLC based, multipurpose console for hooking up
  with a specific equipment configuration.
• Variable speed drives for agitator RPM control
  provided in each reactor.

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Usage Pattern

• Scale up of new processes for synthetics and
  herbals developed at NIPER.
• Prepare batches for clinical trials of New
  Chemical Entities developed at NIPER.
• Carrying out contract production of
  non-commercial quantities for drugs and drug
  intermediates for pharmaceutical industries in
  India and aboard.
• Carry out custom synthesis for Indian
  Pharmaceutical Industry.

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NIPER wishes to thank the following agencies
involved in creating these facilities
M/s Process and Design Engineering Co., Chandigarh, Design Consultant M/s. Planners Group, Chandigarh, Architects M/s. Gautam Builders, Chandigarh, Civil Construction
M/s. Global engineers Limited, New Delhi, Steel Equipments M/s. Nile Limited, Hyderabad, M.S. glass lined Equipment M/s. Suraj Mechtech Pvt. Ltd., Mohali, Steel fabrication Installations
M/s. Chandigarh Electrical Pvt. Ltd., Chandigarh, Electrical Installations M/s. Airtech Engineer, New Delhi, Refrigeration M/s. Advance Automation, Chandigarh, Automation
M/s. Beltek Engineering, Chandigarh, Instrumentation M/s. Perfect Insulation, Chandigarh, Insulation M/s. Ranjit Brothers, Mohali, Furniture
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Terms and Conditions

• 1 NIPER will provide facilities for a period of
  one year
• 2 A minimum of three months notice is required
  for termination of agreement
• 3 Any company who is interested to use facilities
  for scale up of API and or Herbal products
  developed in their R D
• 4 All raw and packing materials including for
  cleaning, scrubbing etc required for scale up are
  to be supplied by the company
• 5 All validated STP and SOP are to be provided by
  the company
• 6 Plant to be made available for NIPER usage for
  own process scale up on a month notice
• 7 Hazard studies to be provided before taking any
  scale up
• 8 MSDS of all chemicals to be provided before
  their usage
• 9 The amount of two months advance is to be
  deposited with NIPER