Air Based Hazard, M.Pharm, Sem 2,Bhumi Suratiya, Pharmaceutical Quality Assurance. Source of air based hazard, types of air based hazard, air circulation maintenance for sterile and non sterile area . Application of air circulation, HEPA filter, clean area classification.

1. Air Based Hazards
Prepared by
Bhumi P. Suratiya
M.Pharm (Sem-II)
MQA201T
Guided By
Dr. Dhara Patel
(M.Pharm, PhD)
(Associate professor)
Pharmaceutical Quality Assurance
Pioneer Pharmacy College, Vadodara

2.  Introduction
 Sources of air pollution
 Types of air based hazard
 Air circulation maintenance industry for sterile
area and non sterile area
 Introduction
 Objective
 Application
 Air circulation maintenance industry for
sterile area
 Air circulation maintenance industry for non
sterile area
Content 2

3. Introduction[1]
 A Hazard is any source of potential damage, harm or adverse health effects on
something or someone.
Basically, a hazard is the potential for harm or an adverse effect
(for example, to people as health effects, to organizations as property or equipment
losses, or to the environment).
 AIR BASED HAZARDS include air pollution also.
 Air pollution can be defined as the presence of toxic chemicals or compounds in the
air, at certain level that cause a health risk. Air pollution means the presence of
chemicals or compounds in the air which lowers the quality of air or cause
detrimental changes to quality of life.
3

4.  Outdoor air pollution is also known as
Ambient air pollution.
 This pollution is caused by emissions from cars,
trucks, industries, construction sites, and many
more activities.
 These emitted pollutants are harmful to our
health.
 Out of all pollutants, fine particulate matter is
most harmful. Majority of the fine particulate
matter comes from the burning of coal, diesel
and petrol by vehicles, power plants, industries
and biomass burning.
Sources of air pollution[2]
4

5.  Indoor air pollution is also known as
Household air pollution.
 It means contamination of air inside houses,
buildings and work areas.
 Chulhas, dust & smoke contribute to
household air pollution.
 Indoor air pollution is equally, but it is not
more harmful than outdoor air pollution.
Sources of air pollution[2]
5

6. Types of air based hazard[3,4]
Air pollutants can be classified according to their origin:
Natural
Sources
• such as fire particles, volcanic eruptions and
degradation of organic matter.
Man-made
Sources
• which are the result of various human
activities.
6

7. 7

8. Air circulation maintenance
industry for sterile area and
non sterile area
8

9. Introduction[3]
► Air circulation system plays a major role in the quality of pharmaceutical
product manufacturing (of all types).
► It is the technology of indoor and manufacturing space environmental control
and or comfort.
► The uncontrolled environment can lead to product degradation, loss of product
and product contamination/cross contamination.
9

10.  To understand the need for air handling system in
the pharmaceutical industry.
 The technical requirements for air handling system.
 Different types of air handling system.
 Qualification and validation of HVAC system.
 Monitoring and maintenance.
Objective[3]
10

11. Application of air circulation[3]
1. Product
protection:
• Protect from
contamination,
cross
contamination,
prevent
contamination
from operatives,
correct
conditions of
humidity and
temperature.
2. Personnel
protection:
• Prevent contact
with dust,
prevent contact
with fumes,
good comfort
conditions.
3. Environmental
protection:
• No dust
discharge, no
fumes
discharge, no
effluent
discharge.
4. Preservation of
materials and
equipment:
• Handling,
holding and
storage.
11

12. ► Clean areas for the manufacture of sterile products are
classified according to the required characteristics of
the environment.
► Each manufacturing operation requires an appropriate
level of environmental cleanliness in the operational
state to minimize the risks of particulate or microbial
contamination of the product or materials being
handled.
► classification of cleanliness according to
concentration of airborne particles.
Air circulation maintenance
industry for sterile area[5]:-
12

13. For the manufacture of sterile pharmaceutical preparations, four
grades of clean areas are distinguished as follows:
The local zone for high-risk operations.
e.g. filling and making aseptic connections.
Unidirectional air flow systems should provide a homogeneous air
speed of 0.36–0.54 m/s (guidance value).
Grade
A:
In aseptic preparation and filling, this is the background environment
for the Grade A zone.
Grade
B:
Clean areas for carrying out less critical stages in the manufacture of
sterile products or product is not directly exposed.
i.e. aseptic connection with aseptic connectors and operations in a
closed system.
Grade
C & D:
13

14. Clean area Classification according to USFDA Guideline:-
Grade Class
Particle Size
(0.5 microns)
Particle Size
(5 microns)
Per ft3 Per m3 Per ft3 Per m3
A 100 100 3500 - -
B 1000 1000 35000 7 247
C 10000 10,000 3,50,000 70 2470
D 100000 1,00,000 35,00,000 700 24,700
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15. For sterile area[3]
 Sterile products are very critical and sensitive in nature hence it requires very high
degree of precaution and prevention is required in its preparation and there shall be
strict compliance with standards prescribed by regulatory authorities.
 Air handling units for sterile product manufacturing shall be different from those
of other areas.
 Differential pressure between areas of different environmental standards shall be at
least 15 Pascal (0.06 inches or 1.5mm water gauge), suitable manometers or
gauges shall be installed to measure and verify pressure differential.
15

16. Area Grade
aseptic filling areas B
sterilized components unloading areas C
changing room D
filling operation A
For terminal sterilization the filling
room
C
Manufacturing and component
preparation area
C
After completion of preparation,
washed components and vessels
C
16

17.  Recommended frequencies for periodic monitoring shall be as follows:
o Particulate monitoring in air: 6 monthly
o HEPA filter integrity testing: yearly
o Air change rates: 6 monthly
o Air pressure differential: daily
o Temperature and humidity: daily
o Microbial monitoring: daily
 There shall be written environmental monitoring programs and microbial results
shall be recorded.
17

18.  Air maintenance system is regard as HVAC and refers to
Systems which are mechanical arrangements that treats
outside air to produce cleaned (from dust and microbes)
conditioned air (temperature and humidity) which is
circulated or re-circulated for use in controlled and
critical areas within the pharmaceutical manufacturing
space. OR
 Can be simply said to be a utility system used to provide
air ventilation, heating, cooling and air conditioning
services to a building or a pharmaceutical space for drug
manufacturing.
HVAC means: H= Heating, V- Ventilation; A= Air; C-
Conditioning
Air circulation maintenance
industry for non sterile area[6]:-
18

19. HEPA filter:- 19

20. ► Heating, ventilation and air-conditioning (HVAC) play an important role in ensuring
the manufacture of quality pharmaceutical products.
► A well-designed HVAC system will also provide comfortable conditions for
operators.
► WHO guidelines mainly focus on recommendations for systems for solid dosage
forms also refer to other systems or components which are not relevant to solid
dosage form plants.
► This may assist in providing a comparison between the requirements for solid
dosage-form plants and other systems.
► HVAC system design influences architectural layouts
Airlock positions, doorways and lobbies.
HVAC system for non sterile according to
WHO Guideline :-
20

21. Continue…
►The architectural components have an effect on
Room pressure, differential cascades and cross- contamination control.
►The prevention of contamination and cross- contamination is an essential design
consideration.
►Temperature, relative humidity and ventilation should be appropriate
►Above should not adversely affect the quality of pharmaceutical products during
their manufacture and storage, or the accurate functioning of equipment.
►This WHO guidance focuses on the design, installation, qualification and
maintenance of the HVAC systems.
21

22. 1. Air Pollution supported by U.S. Embassy and consulates in india, accessed on
29-04-2023, Saaf Hawa Aur Naagrik (shan.org.in)
2. Mukesh p., “Air based hazard”,accessed on 29-04-2023,
https://www.slideshare.net/MukeshPatil48/air-based-hazard-248780229
3. Dr. Md. Rageeb, Deepanti G.,A Text Book of Hazards and Safety
Management; pv books;1st Edition; pp 31
4. Air Pollution, Nov.2014;Accessed on 29-04-2023,
https://www.slideshare.net/AnirbanMandal2013/air-pollution-sources
5. World Health Organization WHO Technical Report Series, No. 961, 2011;
Annex 6; WHO good manufacturing practices for sterile pharmaceutical
products.
References
22

23. 6. Dipankar P., “Air circulation maintenance industry for sterile and non sterile
area”, March 2022, Accessed on 30-04-2023, Air circulation maintenance industry
for sterile and non sterile area (slideshare.net)
7. Drug Regulations, Nov 2015; “ WHO Guidance on HVAC Systems for Non
Sterile Pharmaceuticals”;WHO Guidance on HVAC Systems for Non Sterile
Pharmaceuticals (slideshare.net).
References
23

24. Thank you
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