Ventilation System

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

UNIT I
	Room Conditions
System No.	Temp.	RH	Area	AHU No.	Final Filter	Class	Air Changes Per Hr (ACPH)
I	NMT 25°C	60±5%	Aseptic Area (Liquids) Ampoule, Vial Filling & Bulk Filtration Room, Cooling zone, filling air lock 1,2,3	1	HEPA	A/B	> 60
II	25±2°C	60±5%	Component washing area	3	HEPA	D	25
III	NMT 25°C	60±5%	Bulk manufacturing Area, Mfg.Air lock	4	HEPA	C	40
IV	Ventilation	N/A	Sterilization Area (Forced Draft Ventilate)	5	HEPA	D	25
V	Comfort	-	Corridor	7	5µ	-	20
VI	25±2°C	60±5%	OTIC Filling area	10	HEPA	C	30
VII	25±2°C	60±5%	OTIC Mfg area OTIC Air Lock 1,2	11	HEPA	C	30

UNIT II
	Room Conditions
System No.	Temp.	RH	Area	AHU No.	Final Filter	Class	Air Changes Per Hr (ACPH)
I	22˚C ±2˚C	55±5%	Washing and sterilization, BW, Equipment Wash, Material air Lock, PAL 1	1	HEPA	D	25
II	22˚C ±2˚C	55±5%	Filling / Filtration	2	HEPA	A/B	> 60
III	22˚C ±2˚C	55±5%	Manufacturing Room, PAL1-4	3	HEPA	C	40
IV	22˚C ±2˚C	55±5%	Cooling area/PAL 2-4	4	HEPA	A/B	> 60
V	22˚C ±2˚C	55±5%	Sealing PAL 1-2	5	HEPA	D	25
VI	22˚C ±2˚C	55±5%	Corridor, Laundry, Deboxing, Chemist Room	6	HEPA	D	25
VII	22˚C ±2˚C	55±5%	Inspection and Quarantine	7	HEPA	D	25
VIII	25˚C ±2˚C	60±5%	Sterility testing area, Air lock 1,2,3 and cool zone	8	HEPA	A/B	> 60
IX	25˚C ±2˚C	60±5%	Microbiology area (LT air Lock, MLT Room)	9	HEPA	A/C	40
X	25˚C ±2˚C	60±5%	Passage	10	5µ	D	25

NOTE :

* All the critical area (Bulk Filtration, liquid vial filling line including bunging, ampoule filling and sealing 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 PAO test and particle count. Filter is changed in case it fails; appropriate records are maintained of these testing reports.

* The critical operations in the filling area are covered with LAF units with 0.3 micron HEPA filters, as described above.

* Appropriate change rooms are provided for entry, gowning and exit procedure.