cGMP Pilot Plant

Overview

cGMP pilot plant for Extraction, Formulation and Packaging of Traditional (ISM) Herbal Medicinal Formulations- CSIR-IIIM JAMMU

CSIR-IIIM Jammu has created a State-of-the-Art National Facility for small and medium scale manufacturers from north India and the UT of J&K in particular to get their products manufactured under GMP conditions besides its use for research in CSIR-IIIM. The infrastructure for setting up the facility involved the existing building site at IIIM Jammu. A new project framed under National Facility project under Drugs and Pharmaceuticals Research Programme (DPRP) of Department of Science and Technology (DST, Govt of India) entitled ‘cGMP pilot plant for Extraction, Formulation and Packaging of Traditional (ISM) Herbal Medicinal Formulations”, with DST, AYUSH and CSIR/IIIM as the funding agencies. The necessity to have such a project was found compulsory, so as to generate sufficient data for effective regulation and control of herbal / traditional medicines moving into international commerce with standardized authentic materials. The facility is to cater to the needs of IIIM Jammu in terms of preparation of extracts, their formulations in the form of a tablet/capsule/liquid, for preclinical and clinical trials of the NCEs derived from botanicals and being pursued for IND.

Therefore, creation of such a facility, first of its kind in CSIR and in North India shall help CSIR labs interested in producing GMP grade materials. It may also prove a boon for small scale herbal industry to take advantage of this facility which may not be accessible to them due to high cost and maintenance requirements. IIIM can help in setting up of the rules and conditions for herbal products and this shall provide strength to the regulatory authorities for coming up with regulatory guidelines for herbal/botanicals which have yet to be enforced in the country.

There is a need to evolve a system in terms of

  1. Herbal products from botanical leads and INDs
  2. For Pharma review
  3. For standardization of liquid, tablet and capsule preparation for small herbal based pharmaceutical companies.

Basis of Design

Basis of Design:

  • Plant design as per WHO-GMP norms.
  • Uni-directional and Man and material flow.
  • Separate dedicated area for each activity based on respective formulation.
  • In-house dedicated product testing facility.
  • Complete plant area is centrally air-conditioned. The independent supply systems are fed with separated air handling units to avoid cross air contamination. Humidity, Temperature & Pressure gradients also maintained.
  • For avoiding contamination in production area epoxy flooring is considered.
  • Separate entry for man & material in each critical production area to avoid cross contamination.

The following are the capacity of the four main streams of the formulation & packaging plant.

  • Capsule filling & sealing : 500 caps./min (500 mg).

Semi-automatic capsule filling and

Sealing machine                                                       : 60,000 caps/hr

Capsule Polishing Machine

Empty capsule sorter

 

  • Tablet compression :500 Tabs./min (500 mg)

Rapid Mixer Granulator (RMG)                               :15/30 kg

Fluid bed drier (FBD)                                               : 30 kg

Roller compactor                                                      : 20 Kg

Tablet compression machine                                    :16 station

Auto coater                                                               : 28” with 20” & 18” pan

Blister packing machine                                           :100 blister/hr

Strip packing machine                                              :100 strip/hr.

 

  • Liquid filling machine                                      :40 bottles/min (100 ml)

Liquid online preparation tank                                 : 500ltr.

Bottle washing machine                                           : 3000-6000 Bottles/hr.

Bottle filling and sealing machine                             : 40 bottles/hr.

Cap sealing machine                                                : 3000-6000 bottles/batch

 

Area-wise Activities

 

Left Wing Central Wing Right Wing QC/QA Area (First Floor)
Sugar Process Granulation Area Material Store Area Control Sample Room
Syrup Preparation Plant Tablet Compression Area Drying Area Instrument Lab
Bottle Washing Area Tablet Inspection Area Sifted Material Quarantine Incubator Room
Bottle Filling & Cap Sealing  Area Tablet Coating Area Sifting and Pulverising Area Q.A. Documentation Room
Labeling Area Empty Capsule Store Chemist Area Stability Room
Sugar Store Mixing Area  for Capsule Utensil Washing Area Chemical Room
Aluminum Foil Storage Capsule Filling Sealing Area Extraction, Distillation Area Hot Zone
Packing Material Storage Blister Packing Area Control Panel Area Laminar Air Flow Area
Finished Goods Storage  Strip Packing Area  Extract Packing Area Media Preparation Room
Empty Bottle Storage IPQC Area Purification Area
De-dusting Quarantine Area For Tablet Raw Material Under Test Area
Quarantine Area For Capsule Change Rooms For Male, Female and Visitors
Dispensing & Sampling Area

Structure of cGMP

The GMP  unit  comprise of three wings  i.e.  left, central and right wing.

  • Right wing houses Extraction unit and QC/QA section.
  • Central wing houses Formulation  Unit (Tablet  and  Capsule preparation) and  their packaging units.
  • Left Wing houses Liquid orals Formulation Unit, and online bottle filling  unit . It also houses packaging and dispensing of the finished goods (capsules/tablets unit).

The first floor  houses service floor area for  operation of HVAC & FDV  systems.

  • Dedicated utilities i.e. Boiler, Compressor, Chiller are available for process.
  • Dedicated purified water treatment plant also available for extraction and formulation