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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 ... – PowerPoint PPT presentation

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Title: 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
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