Capacity

The capacity of micronizing APIs in the four independent Air Jet Mill Stream is:

 Air Jet Mill  Capacity kg/day
 Stream I  1000
 Stream II  1000
 Stream III  1000
 Stream IV (Pilot)  100


SALIENT FEATURES

  • Facility built as per FDA guidelines
  • Production capacity of 3.0 MT per day
  • Three independent streams
  • Pilot facility for trials
  • Particle size up to 5 micron & below
  • CIP compliant SS316 equipments
  • Series of online filters for clean process air
  • Independent AHUs for each stream & critical areas
  • Appropriate pressure gradients
  • Separate entry for Man and Material
  • Operations observing cGMP guidelines
  • On site laboratory
  • FDA approved experienced work force

The production block has three manufacturing streams (I, II, III) and one pilot stream (IV). Each stream is independent and has dedicated sections for milling, packing, and quarantine. These are ably supported by adequate service departments like Warehouses, Engineering, Quality Assurance and Quality Control.  There is separate entry for movement of man and material.

The equipment installed conforms to Current Good Manufacturing Practice (cGMP) requirements.

All processes related to micronization of Active Pharmaceutical Ingredients (API) including, packaging, and test by the quality control laboratory are carried on at the site.

Separate storage facility is provided for packaging materials and engineering goods. All materials are properly labelled with status label and kept in allotted places. Finished products are segregated and kept in separate warehouse under controlled temperature.