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°+2° |
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°+2° |
60±5% |
Otic Filling Area |
6 |
HEPA |
10,000 |
30 |
6 |
N / A |
N / A |
Corridor |
7 |
5 µ |
- |
30 |
7 |
25°+2° |
60±5% |
Sterility testing area |
8 |
HEPA |
1,000 |
50 |
8 |
25°+2° |
60±5% |
Microbiology area |
9 |
HEPA |
10,000 |
40 |
9 |
25°+2° |
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.