about air handling unit in pharmaceutical industry and total process of HVAC

1. AYON DUTTA
M-PHARM, 1ST YEAR
(PHARMACEUTICS)
BENGAL SCHOOL OF TECHNOLOGY
Affiliated to Maulana Abdul Kalam Azad
University of Technology
Sugandha, Hooghly

2. Objectives:-
 In the following slides, we will study the
components of air handling systems in order to:
1. become familiar with the components
2. know their functions
3. become aware of possible problems

3. FilterSilencer
Terminal filter
Weather louvre Control damper
FanFlow rate controller
Humidifier
Heating
coil
Cooling
coil
with
droplet
separator
Production Room
Overview components
+
Prefilter
Exhaust Air Grille
Heater
Secondary Filter
Re-circulated air

4.  Weather louvre
 Silencer
 Flow rate
controller
 Control damper
To prevent insects, leaves, dirt and
rain from entering
To reduce noise caused by air
circulation
Automated adjustment of volume of
air (night and day, pressure control)
Fixed adjustment of volume of air
Air handling unit(Component 1)

5.  Heating unit
 Cooling unit
/dehumidifier
 Humidifier
 Filters
 Ducts
To heat the air to the proper temperature
To cool the air to the required
temperature or to remove moisture from
the air
To bring the air to the proper humidity,
if too low
To eliminate particles of pre-determined
dimensions and/or micro-organisms
To transport the air
Air handling unit(Component 2)

6. HVAC System
Objectives
To continue from Part 1(a), now focus on:
 Air filtration
 The role of HVAC in dust control
 HVAC system design and its components (part 2)
 Commissioning, qualification and maintenance (part 3)

7. HVAC
Levels of protection and recommended
filtration
Recommended filtrationLevel of
protection
Primary filters, e.g. EN779 G4*Level 1
Production area with 100% outside air: Primary plus
secondary filter (e.g. EN779 G4 plus F8 filters)
Level 2 and 3
Production area with recirculated plus ambient air with a
risk of cross-contamination: Primary plus secondary plus
tertiary filter (e.g. EN779 G4 plus F8 plus EN1822 H13
filters)
Level 2 and 3

8. Primary panel
filter(Grease filter)
Secondary
filter(Oil filter)
HEPA or tertiaary filter(dust filter)
HVAC

9. HVAC
Contamination should be prevented through
appropriate:
 Materials for components and construction
 Design and appropriate access to dampers, filters and other
components
 Personnel operations
 Airflow direction
 Air distribution component design and installation and
location
 Type of diffusers (non-induction type recommended)
 Air exhaust (normally from a low level)
4.2.4 – 4.2.10

10. Low induction
swirl diffusor
(preferred)
High induction
office type diffusor
(avoid)

11. HVAC
Airflow patterns
Filtered air entering a production room or
covering a process can be
 turbulent, or
 unidirectional (laminar)
 GMP aspect
 economical aspect
Other technologies: barrier technology/isolator
technology.

12. Unidirectional/laminar
displacement of dirty air
Turbulent
dilution of dirty air
Airflow patterns
HVAC

13. PrefilterAirflow patterns
AHU
Main filter
Unidirectional TurbulentTurbulent
1 2 3
HVAC

14. Workbench (vertical) Cabin/booth Ceiling
Airflow patterns (4)
HVAC

15. HVAC
Unidirectional airflow (UDAF):
Provided where needed over product or material to
prevent contamination, or to protect operator
UDAF in weighing areas
 The aim is to provide dust containment
 Airflow velocity should not affect balance
 Position of material, balance, operator determined
and validated – no obstruction of airflow or risk

16. HVAC

17. HVAC
Infiltration
 Facilities normally under positive pressure to the
outside
 Prevent infiltration of unfiltered, contaminated
air from outside
 Some cases - negative pressure (e.g. penicillin
manufacture). Special precautions to be taken

18. HVAC
General aspects
 Multiproduct OSD manufacturing, prevent movement
of dust between areas where different products are
processed
 Directional air movement and pressure cascade can be
helpful – dust containment
 Normally, corridor at higher pressure than cubicles,
cubicles at higher pressure than atmosphere

19. Pressure cascade solids
Protection from cross-contamination
Note : Direction of door opening relative to room pressure
15Pa
15Pa15Pa
E30Pa
Passage
0Pa
Air
Lock
Room 3Room 2Room 1
15Pa
Air LockAir Lock
HVAC

20. Temperature , humidity & dust control
 Controlled, monitored and recorded where relevant
 Premises design appropriate, e.g. low humidity
areas, well sealed and airlocks where necessary
 HVAC design – also prevent moisture migration
 Dehumidification
 Refrigerated dehumidifiers with cooling media
 Chemical dehumidifiers
 Dust and vapour removed at source
 Ensure sufficient transfer velocity to prevent dust
settling in ducting

21. Cleanroom Class
defined by
Critical Parameters
Air Handling
System
Additional Measures
Tools to help achieve the desired Level of Protection
HVAC

22. Types of Clean room classes
 WHO, EC, PIC/S: A, B, C, D
 US FDA: Critical and controlled
 ISPE: Level 1, 2 or 3
 ISO: Class 5, 6, 7 or 8
HVAC

23. Particles / m3
 0.5µm
US 209D
non-
metric
US 209E
1992
metric
EC cGMP
Annex I
1997
Germany
VDI 2083
1990
UK
BS 5295
1989
Japan
JIS B 9920
1989
ISO 14644-
1
1
3,5 0 2 2
10 M 1
35 1 M 1.5 1 3 3
100 M 2
353 10 M 2.5 2 4 4
1.000 M 3
3.530 100 M 3.5 A, B
A= unidirectional
B= turbulent
3 E or F 5 5
10.000 M 4
35.300 1.000 M 4.5 4 G or H 6 6
100.000 M 5
353.000 10.000 M 5.5 C 5 J 7 7
1.000.000 M 6
3.530.000 100.000 M 6.5 D 6 K 8 8
10.000.000 M 7
Comparing International Cleanroom Classifications
HVAC

24. HVAC
Schedule of tests to demonstrate continuing compliance
Test procedure*
and key aspects
Maximum time
interval
ObjectiveTest Parameter
Particle counter.
Readings and
positions
6 months or 12
months depending
on Class
Verifies cleanlinessParticle count test
Measure pressure
difference
12 monthsAbsence of cross-
contamination
Air pressure
difference
Measure supply and
return air, calculate
air change rate
12 monthsVerify air change
rates
Airflow volume
Velocity
measurement
12 monthsVerify unidirectional
airflow and or
containment
condition
Airflow velocity

25. HVAC
Recommended optional strategic tests
Test procedure*
and key aspects
Maximum time
interval
ObjectiveTest Parameter
Filter media and filter
seal integrity
12 monthsVerify filter integrityFilter leakage
Airflow direction and
pressure differential
12 monthsVerify absence of
cross-contamination
Containment leakage
Time taken
maximum 15
minutes
12 monthsVerify clean-up timeRecovery (time)
Airflow direction,
documented
evidence
12 monthsVerify required
airflow patterns
Airflow visualization