Air Based Hazard, Preliminary Hazard Analysis, Fire Protection System

Air Based Hazard, Preliminary Hazard Analysis, Fire Protection System

1. AIR Based Hazards
BY – Shreeharsh Sharma
Pharmaceutical Quality Assurance
0001PY23MP20
School of Pharmaceutical Sciences
Rajiv Gandhi Proudyogiki Vishwavidyalaya

2. Contents:
❖What is Air hazards.
❖Sources of air hazards.
❖Effect of Air hazards on human and environment.
❖Air circulation maintenance for sterile and non-sterile area.
❖Preliminary hazard analysis.
❖Fire protection system.
❖Types of fire extinguisher.

3. What is Hazards
We can define hazards as –
“The potential occurrence of a natural or
human-induced physical event or trend that
may cause loss of life, injury, or other health
impacts.”
Hazards is something which could be
dangerous to you, your health, safety, or your
plans or reputation.

4. Air Hazards
Air hazards can also be called as Air Pollution.
It may be defined as –
“The presence of toxic chemicals or compounds in the
air, at certain level that posses a health risk.”
Air pollution also refers to the presence of chemicals or
compounds in the air which lowers the quality of air or
cause detrimental changes to quality of air.

5. 40.8
42.4
42.4
43
43.8
46.6
49
54.4
73.7
79.9
0 10 20 30 40 50 60 70 80 90
Demo. Rep. of Congo
Nepal
Egypt
UAE
Iraq
Burkina Faso
Tajikistan
India
Pakistan
Bangladesh
Weighted Annual Average PM 2.5 Concentration
Countries
Most Polluted Countries in the World 2023
World Air Quality Report

6. Sources of Air Hazards
➢Burning of gasoline, diesel and other fuels for transportation

7. Sources of Air Hazards
➢Emission from various industrial processes.

8. Sources of Air Hazards
➢Burning woods and other fuels for heating and cooking

9. Sources of Air Hazards
➢Agriculture burning, land clearing and other man-made fires.

10. Sources of Air Hazards
➢The combustion of coal, oil, gases and other fuels for
generating electricity.

11. Sources of some common pollutants
❖Carbon Monoxide: Incomplete combustion of carbon-
based fuels.
❖Nitrogen Oxides : Emitted from motor vehicles.
❖Heavy Metals: Combustion of fuels containing lead
additives. Mercury is emitted from
burning of fossils fuels.
❖Particulate Matter: Diesel emission, power plants,
industrial facilities, domestic
cooking and heating.

12. Effects of Air Hazards on Humans

13. Effects of Air Hazards on Environment
❖Smog: Smog (ground-level ozone) describes as a
mix of smoke and fog. It often result in reduced
visibility.
❖Soot: Soot is a black powder composed mainly of
carbon, produced when coal, wood, etc are burned
and often carried in air.
❖Greenhouse Effect: By trapping the earth’s heat in
the atmosphere, greenhouse gases lead to warmer
temperature. Causes climate change, rising sea
level, more extreme weather, heat related deaths
and increasing transmission of infectious diseases.

14. ➢Air maintenance system plays a major role in the quality of
pharmaceutical product manufacturing companies.
➢The manufacturing environment or space is very critical to product quality
and is dependent on the air handling system which controls the levels of
containment and cleanliness.
➢Air maintenance system has to satisfy GMP requirements must be suitably
designed, installed, qualified/validated, monitored and maintained by
professionals.
➢The uncontrolled air handling can lead to product degradation, loss of
product, and economic issue-profit, product contamination/cross
contamination.
Air Circulation Maintenance for Sterile and
Non-Sterile Area

15. What is Air Maintenance System
➢Air maintenance system is regards to HVAC system.
➢It is a mechanical system that treat outside air to produce clean, conditioned
air which is circulated or re-circulated for use in controlled and critical areas
within the pharmaceutical manufacturing site.
➢It is a utility system used to provide air ventilation, heating, cooling and air
conditioning services to building or a pharmaceutical space for drug
manufacturing.
➢HVAC means H=Heating, V= Ventilation, A= Air, C= Conditioning

16. Sterile Area
➢Positive Pressure : It maintain positive air pressure compared to surrounding,
this prevent contaminants to enter sterile area.
➢HEPA Filter : Air entering sterile area should pass through HEPA filter to
remove particulate matter and microorganism.
➢Frequent Air Change : Sterile area often require a higher rate of air changes
per hour to minimize the concentration of airborne contaminants.
➢Isolation : Sterile area may need to be physically isolated from other to
prevent contamination.

17. Non-Sterile Area
➢Controlled Airflow : While not as stringent as sterile area but non-sterile still
requires controlled air flow to maintain air quality and prevent stagnation.
➢HEPA Filter : Depending on the application, non-sterile area may also use
HEPA filter, especially in environment sensitive to air borne particle.
➢Regular Maintenance : Filter, ducts and ventilation system should be
regularly inspected and cleaned to prevent buildup of dust and other
contaminants.
➢Proper Ventilation : Non-sterile area may require specific ventilation system
to remove fumes, odors and other pollutants.

18. Preliminary Hazard Analysis (PHA)
Preliminary hazard analysis is a semi-quantitative analysis that is
performed to:
➢Identify all potential hazards and accidental events that may
lead to an accident.
➢Rank the identified accidental event according to their
severity.
➢Identify required hazard control and follow-up action.
PHA is an initial high level screening exercise that can be used to
identify, describe and rank major hazards during conceptual stage
of facility design

19. PHA Procedure
The Preliminary Hazard Analysis involves mainly four steps:
❖PHA prerequisites.
❖Hazard identification.
❖Consequence and frequency estimation.
❖Risk ranking and follow-up action.

20. 1. PHA Prerequisite
❖Establish PHA team. PHA team may consist of:
➢A team leader,
➢A secretary who will report the result,
➢Team member (2-6 person)who can provide necessary
knowledge and experience on the system being analyzed.
❖Define and describe the system to be analyzed.
❖Collect risk information from previous and similar system

21. 2. Hazard Identification
❖All hazards and possible accidental events must be identified.
❖To get complete survey of all possible hazards, Hazard Checklist
is used.
❖The PHA team review hazard checklist and standards.
❖Common source of hazards are:
➢Mechanical moving parts,
➢Material or system incompatibilities,
➢Nuclear radiation,
➢Fire and explosion.

22. 3. Consequence and Frequency Estimation
❖The risk related to an accidental event is a function of the frequency of
the event and the severity of its potential consequences.
❖To determine the risk, we have to estimate the frequency and the
severity of each accidental event.
❖Frequency classes:
➢1 Very unlikely Once per 1000 years or more seldom
➢2 Remote Once per 100 years
➢3 Occasional Once per 10 years
➢4 Probable Once per year
➢5 Frequent Once per month or more often

23. 4. Risk Ranking and Follow-Up Actions
❖The risk is established as a combination of a given event and severity of
the same event. This enables ranking of the event in risk matrixFrequency/
Consequence
1
Very Unlikely
2
Remote
3
Occasional
4
Probable
5
Frequent
Catastrophic
Critical
Major
Minor
Not Acceptable
Acceptable with needed changes
Acceptable

24. 4. Risk Ranking and Follow-Up Actions
❖Risk Levels
Level Name Description
H
High
High risk, not acceptable. Further
analysis should be performed to give
a better estimate of the risk.
M Medium
The risk may be acceptable, but
redesign or other changes should be
considered if reasonably practical.
Need of remedial action.
L Low
The risk is low and further risk
reducing measures are not required.

25. Fire Protection System
❖Fire protection include procedure for preventing, detecting and
extinguishing fire.
❖The procedure in these three areas of fire prevention aim to
protect employees and property and to assure the continuity of
plant’s operations.
❖To accomplish these goals, it is necessary to develop a plant wide
fire protection program.

26. Prevention of Fire Hazards
❖Well planned design and layout.
❖Proper ventilated system.
❖Chemical date sheets.
❖Proper training of personnel.
❖Proper maintenance of surrounding.
❖Use of fire extinguishers, alarms, sensor, detectors.
❖Fire fighting equipment.
❖Sprinkler system

27. Type of Fire

28. Fire Extinguishers
❖A fire extinguisher is a device which can be used to control a fire.
Fire extinguisher can help remove fire and may stop it from
burning.
Types of fire extinguisher:
➢Water
➢Carbon Dioxide
➢ABC type dry powder
➢Dry Powder
➢Foam based extinguisher
➢Clean agent fire extinguisher

29. 1. Water Extinguisher
❖Water extinguisher are used for class A fire only.
❖Water extinguishes by absorbing the heat and so cooling the fire.
❖Easy and no maintenance and service.
❖Color band - Red
2. Carbon Dioxide Extinguisher
❖Carbon dioxide can be used on class B & C fires
❖Color band – Black
❖Used in – Rail yards, Construction site, Electric Substation

30. 3. ABC Type Dry Powder
❖It is multi-purpose extinguisher comprise of special fluidized and
siliconized mono ammonium phosphate dry chemical.
❖Used for class A fire and break chain reaction in class B and C fire.
❖Color band - Blue
4. Dry Powder
❖Dry chemical powder extinguishers utilize a special siliconized
bicarbonate.
❖Insulates class B, C fire by forming a cloud and cutting off the oxygen.
❖Color band - Blue

31. 5. Foam Based Extnguisher
❖Foam has the ability to form an aqueous film quickly over water-
insoluble hydrocarbon fuel surface causing rapid fire extinguishment
and vapour suppression for class B fire.
❖Used for class A and B fire.
❖Color Band - Yellow
6. Clean Agent Fire Extinguisher
❖Clean agent uses Halon 1211 as the agent-of-choice for application
where the agent must be clean, electrically nonconductive,
environment-friendly, extremely low in toxicity.
❖Suitable for Class A, B and C fire.
❖Color band - Green

32. Thank You