Professional Documents
Culture Documents
Air Handling System in Pharmaceutical Manufacturing
Air Handling System in Pharmaceutical Manufacturing
PHARMACEUTICAL
MANUFACTURING
A presentation By
Pharm R.A.BINITIE
Assistant Director
Drug Evaluation and Research Directorate
NAFDAC
AHU SECTION
Production Room
Central air handling unit
+
Prefilter Humidifier Terminal filter
Adsorber wheel
Humid room air Filter Pressure
Gauges
Air heater
Feb 25, 2021 19
AIR HANDLING SYSTEM IN
PHARMACEUTICAL MANUFACTURING
CHARACTERISTICS OF AIR HANDLING SYSTEM/HVAC
• Turbulent air flow ( air flow pattern)
• Unidirectional airflow ( air flow pattern)
• Filter position ( Terminal Position, air recirculation
system)
• Fresh air (100%)/Once through / external air
• Air re-circulation
• Return air systems (positions low wall air return)
• Overpressure requirements
• Local extraction system( deduster, canister)
Fresh air
(make-up + Exhaust
Supply air
air)
air
Production Room
Return air
(recirculated)
Return air
0,30 m/s
Prefilter
AHU
Main filter
Ceiling
exhausts
1 2 3
TERMINAL ( AHU OR 47
ROOM SUPPLY VENT
AIR HANDLING SYSTEM IN
PHARMACEUTICAL MANUFACTURING
POSITIONING OF HEPA FILTERS (2)
HEPA Filter
AHU
Main filter
Ceiling
exhausts
1 2 3
AHU
Prefilter
1 2
Parallelism 2 N/A
Air flow pattern ( Smoke test) 2 3
Uni-directional Turbulent /
Test Description
airflow / LAF mixed airflow
A L E R T L IM IT A L E R T L IM IT
D e s ig n C o n d it io n
N o r m a l O p e r a t in g R a n g e
O p e r a t in g R a n g e - V a lid a t e d A c c e p t a n c e C r it e r ia
air
Sampling point
Depyrogenisation of containers X
3
4
1. Filter
2. Tightening frame
3. Registered outlet
4. Screw fixation for
register
PHARMACEUTICAL MANUFACTURING
Room pressure
Room pressure indication panel gauges
Room pressure
indication panel could
also be electronic type
Feb 25, 2021 79
AIR HANDLING SYSTEM AND
PHARMACEUTICAL MANUFACTURING
INSPECTING THE AIR HANDLING PLANT
THANK YOU
THANK YOU
THANK YOU
Feb 25, 2021 84
CASE STUDY 1
A multiproduct OSD pharmaceutical company
with a central HVAC system of recirulated air has
just commenced operation in Nigeria and one of
the product being manufactured in the facility is
misoprostol. It was noticed that air supply to
production was by induction system and during a
production section water was observed to be
dripping from the false ceiling void along the
HVAC duct .
What do think are a stake in this situation?- Outline