Air Handling System for Sterile Area, Component Washing Area and Sterilisation Area.
Following areas are equipped with independent air handling systems as indicated.

System Room Cond. Area AHU No. Final
Filter
Class Air change
( No. )
Temp. °C RH.%
1 NMT 25° 60±5% Aseptic Area (Liquids) Ampoule, Vial Filling & Bulk Filtration Room 1 HEPA 1,000 > 60
2  25°+ 60±5% Component Washing Area 3 HEPA 1,00,000 40
3 NMT 25° 60±5% Bulk Manufacturing Area 4 HEPA 10,000 40
4 Ventilation N/A Sterilisation Area (Forced Draft Ventilate)   5 HEPA 1,00,000 40
5 25°+ 60±5% Otic Filling Area 6 HEPA 10,000 30
6 N / A N / A Corridor 7 5 µ - 30
7 25°+ 60±5% Sterility testing area 8 HEPA 1,000 50
8 25°+ 60±5% Microbiology area 9 HEPA 10,000 40
9 25°+ 60±5% Clean Room 10 5 µ 1,00,000 20
N / A – Not Applicable
* Detailed drawings with area served by each system is given in the Annexure [ Refer : Annexure I (a) to I (g) ]

Note:
  • All the critical operations (at the point of the operation) – Bulk Filtration, liquid vial filling line Including bunging, ampoule filling line, are provided with Adequate No. of Laminar Flow Modules with 0.3 µ HEPA Filters.
  • Air handling system comprises of pre-filters of 20 µ and 5µ porosity & a terminal HEPA filters of appropriate rating & efficiency 99.997%. These filters are fitted into the system.
  • The system is designed to achieve the required working temperature, relative humidity, air changes and pressure differentials between the adjoining areas. HEPA filter integrity is tested periodically by D.O.P. test and particle count. Filter is changed incase it fails. Appropriate records are maintained of this testing reports.
  • The critical operations in the filling area are covered with L.A.F. units with 0.3 micron HEPA filters, as described above.
  • Facility for sterile gowning in 3 stage change rooms is provided separately.