The capacity of micronizing APIs in the four independent Air Jet Mill Stream is:
|Air Jet Mill||Capacity kg/day|
|Stream IV (Pilot)||100|
- 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.