Manufacturing Area having independent AHU, these are circulatory type through a bank of 10 µ - / 5µ and .3 µ terminal HEPA filter to achieve class 100000. Class 100,000 is comprises of air changes more then 30 and particle count for viable and non-viable and DOP test. There is total 28 Nos of AHU at service floor with insulated ducting, 10% fresh air is used.
Positive air pressures are maintained in the compounding, filling and dispensing areas to ensure that outside air does not enter these areas.
The manufacturing, primary packing as well as the dispensing areas are validated at regular frequency for integrity of filters, particle counts, air velocities and number of air changes.
The flooring in the entire core areas as well as the corridors, dispensing area and sampling area and the also the microbiology laboratory is coated with epoxy with a clear coat of Poly Urethane in order to have an impervious microbe resistant floor.
The maintenance department provides the following utilities:
- Compressed Air
- Vacuum System
- Air Handling System
- Chilled water
Preventive Maintenance of all equipment is the responsibility of the engineering department, which is headed by the Maintenance Engineer. There are SOPs stipulating the preventive maintenance frequency, person responsible, and the procedures to be followed for preventive maintenance in the case of each equipment.