Hazards and Safety Management, Chapter 2 : Air Based Hazards. Prepared according to M.pharm 2nd semester syllabus prescribed by RGUHS.

1. HAZARDS AND SAFETY MANAGEMENT
AIR BASED HAZARDS
PREPARED BY: IRENE LALBIAKNUNGI & AHMAD HOJABRIAN
M.PHARM 2ND SEMESTER
DEPARTMENT OF PHARMACEUTICAL QUALITY ASSURANCE
NARGUND COLLEGE OF PHARMACY
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2. CONTENT:
1. Introduction
2. Sources
3. Air circulation maintenance
4. PHA ( Preliminary Hazard Analysis)
5. Fire Protection System :
• fire prevention
• Fire extinguishers
6. Critical hazard management system
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3. Introduction:
Hazard is the potential for harm. It is often associated with a condition or activity that can cause undesired
consequences such as injury or illness if left uncontrolled.
Air pollution can be defined as the presence of toxic chemicals or compounds in the air, at certain level that pose a
health risk.
Sources:
1. Sources of energy generation: This is where CO₂, SO₂ and water vapour are released in the atmosphere as large
amount of coal, oil, LP/natural gas, gasoline and bio-fuels are used in combustion.
2. Transport: This is mobile and most leading source of CO. Combustion in engines is mainly fuelled by gas, petrol,
diesel and kerosene. Jet engines of sub sonic long range air crafts are major source of NO₂. Traffic on road is
considered as non-point or line source, addition to that harbours and turbine engines of huge ships also emits
tons of greenhouse gases and toxic particles in the air. 3

4. 3. Industry: Most of the industries are directly or indirectly depend on fossil fuel, as they produce CO and CO₂,
sulphur hexafluoride and particle matters. Mainly cement industry releases large amount of particle matters in the
environment. There is an array of hazardous volatile compounds that are released from paints, electronics, dry
cleansing, decreasing agents. Also, utilization of HFC, Oxides of Nitrogen and SF₆ produces pollutants.
4. Households: Carbon and soot emission during the cooking using fossil fuels can be considered here. Volatile
toxicants such as Permethrin compounds from insecticides could contaminate in the air or even food and resulting in
the intoxication.
5. Agricultural practices: Agriculture activities such as use of natural fertilizer release greenhouse gases. Pesticides
release persistent organic pollutants (POP). Enteric fermentation in cattle ranching produces green house gases mainly
methane. Toxic chemicals found in pesticide and weedicide also reduces the quality of air inhaled.
6. Land mining, earth moving activity and quarrying: Process of mining large mineral deposits in the earth
accompanied with emission of dust and other chemicals. Blasting, quarrying limestone in cement manufacturing
produces dust particles.
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5. 7. Construction and repair works: Drilling, blasting, transportation, loading and unloading activities often causes dust
generation. In addition, there are several non-point anthropogenic sources related to dust generation such as welding,
painting, auto mobile repairing, etc.
8. Burning of wastes and Incinerators: This is more severe threat to the environment as it contaminates the
atmosphere with persistent organic pollutants (POP) such as dioxins, major sources are plastics and electronic wastes.
In addition, as in normal combustion carbon is emitted as oxides and soot. Wastes are in a vast array such as plastic,
electronic wastes, cement dust, industrial chemicals, paper, glass, steel and various derivatives of soil minerals,
biological and medicinal wastes, drugs and other chemicals. Incinerators destroys the hazardous effect of any gas or
particle and the remaining dust emission could be as smalls as PM10-PM2.5 or lesser, unless right particle filters are
used it is also end up with adverse results.
9. Natural sources: Compounds released from volcanic activities such as black smoke, ash, metals, SO x , CO x and
release of methane form thawing of permafrost regions in the northern hemisphere, wetlands, sanitary landfills.
Forest fires and bush fires, dust storm, sea spray and conversion of land use and release of isoprenes and terpenes by
forest (precursors of low-level ozone).
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6. Air Circulation Maintenance Industry :
HVAC systems.
• 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 .
• The guidelines 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.
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7. • 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.
• The design of HVAC system should be considered at the concept design stage.
• 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.
• The WHO guidance focuses on the design, installation, qualification and maintenance of the HVAC system.
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8. Preliminary Hazard Analysis:
Preliminary hazard analysis is a semi quantitative process that is performed to:
• Identify all potential hazards and accidental events that may lead to an accident.
• Rank the identified accidental events according to their severity.
• Identify required hazard controls and follow-up actions.
Purpose/ Use of PHA:
1. As an initial risk study in an early stage of a project (e.g., of new plant). Accidents are mainly caused by release of
energy. The PHA identifies where energy may be released and which accidental events that may occur and gives a
rough estimate of the severity of each accidental event. The PHA results are used to:
• Compare main concepts.
• Focus on important risk issues.
• Input to more retailed risk analyses.
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9. 2 As an initial step of a detailed risk analysis of a system concept or an existing system.
The purpose of the PHA is then to identify those accidental events that should be subject to a further and more
detailed risk analysis.
3. As a complete risk analysis of a rather simple system.
Whether or not a PHA will be sufficient analysis depend both on the complexity of the system and the objectives of
the analysis.
4. Applied during the conceptual design or R&D phase of a process plant.
5. Commonly used as a design review tool before a process is developed.
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10. Benefits of PHA:
1. The final product must be "safe". A PHA helps designer to identify and deal with hazards.
2. Modifications that are made in the earlier stages are less costly and easier to implement than modifications that
are made in the later design stage.
3. Helps the designers to anticipate hazards, thereby reducing the number of surprises that occur during the design
process.
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11. PHA Scope:
The PHA shall consider the following factors:
• Hazardous plant equipment and materials (fuels, highly reactive chemical, toxic substances, explosive, high pressure
system, etc.).
• Safety related interfaces between plant equipment items and materials (material interactions, fire/explosions
initiation and propagation, and control/shutdown systems).
• Environmental factors (earthquake, vibration, flooding, extreme temperatures, electrostatic discharge, and
humidity).
• Operating, test, maintenance, built-in tests, diagnostics, and emergency procedures.
• Facilities support (storage, testing equipment, training utilities).
• Safety related equipment (mitigating systems, fire suppression and personal protective equipment).
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12. PHA Procedure: The main steps are:
1. PHA prerequisites
2. Hazard identification
3. Frequency and consequence estimation
4. Risk ranking and follow-up actions
PHA prerequisites:
• Develop PHA team
• Define and describe the system to be analyzed
• System boundaries
• System description (lay out drawings, process flow diagrams, block diagrams, etc.)
• Use and storage of energy and hazardous material in the systems.
• Operational and environmental conditions to be considered.
• System for detection and control of hazards and accidental events, emergency system, and mitigation actions.
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13. • Collect risk information from previous and similar system (for accident data bases).
a). PHA Team: A typical PHA may consist of a:
• A team leader (facilitator) with competence and experience in the method to be used.
• A secretary who will report the results.
• Team members (2-6 persons) who can provide necessary knowledge and experience on the system being analyzed.
• How many team members who should participate will depend on the complexity of the system and the objectives
of that analysis. So, team members amay participate only in parts of the analysis.
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14. b. System/Program:
System function: As a part of system familiarization.
• What is the system dependent upon (inputs)?
• What activities are performed by the system?
• What services does the system provide (output)
System breakdown: To be able to identify all hazards and events, it is often necessary to split the system into
manageable part, for example, into three categories:
• System parts (e.g., process units)
• Activities
• Exposed to the risk (Who, what are exposed?)
Selection of a PHA worksheet: The results of the PHA are usually reported by a PHA worksheet (or, a computer
program).
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15. 2. Hazard Identification:
All hazards and possible accidental events must be identified. It is important to consider all parts of the system,
operational modes, maintenance operations, safety systems. All findings should be recorded. No hazards are too
significant to be recorded.
The common evaluation techniques that have been used to identify the hazards are:
Hazard Checklist: To get the complete survey of all possible hazards it may be beneficial to use a hazard checklist,
examples of checklist question are:
• Is the material flash point below 100° F?
• Does the material react with water? Does the material polymerize?
Common sources of hazards:
• Sources and propagation paths of stored energy in electrical, chemical or mechanical form.
• Mechanical moving parts
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16. • Material or system incompatibilities.
• Nuclear radiation.
• Electromagnetic radiation (infra red, ultra-violet, laser, and radio frequencies) Collisions and subsequent problems
of survival and escape.
• Fire and explosion .
• Toxic and corrosive liquid and gases escaping from containers or being generated as result of other incidents.
• Deterioration in long-term storage.
• Noise.
• Biological hazards.
• Human error in operating of the system.
• Software error that cause accidents. 16

17. How to identify hazards?: To identify hazards you can:
• Examine similar existing systems.
• Review previous hazard analyses for similar systems.
• Review hazard checklists and standards.
• Consider energy flow through the system.
• Consider inherent hazardous materials.
• Consider interactions between system components.
3. Frequency and consequence estimation:
Frequency: 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, estimation of the frequency and the severity of each accidental event should be done.
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18. Consequences:
• An accidental event may lead to wide range of consequences, ranging from negligible to catastrophic. A fire may, for
example, be extinguished very fast and give minor consequences, or lead to a disaster.
• In some applications the severity of an average consequence of an accidental event is assessed.
• In other applications we consider several possible consequences, including the worst foreseeable consequence of
the accidental event.
4. Risk ranking and follow-up actions: The risk is established as a combination of a given event/consequence and a
severity of a same event/consequence.
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19. FIRE PROTECTION SYSTEM
Fire Prevention: Fire Prevention is a function of many fire departments. The goal of fire prevention is to educate
the public to take precautions to prevent potentially harmful fires and can be educated about surviving them. It is a
proactive method of reducing emergencies and the damage caused by them.
Fire Prevention Triangle: Heat, Oxygen and Fuel
A fire needs three elements-heat, oxygen and fuel. Without heat, oxygen and fuel a fire will not start or spread. A key
strategy to prevent fire is to remove one or more of heat, oxygen, or fuel. The risk assessment should include detail on
all three elements to minimize the risk of a fire starting/spreading.
A fire prevention strategy and a fire risk assessment should include detail and full consideration of all the issues
including issues arising from heat, oxygen and fuel.
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20. Advice on these three elements is as follows:
1.Heat: Heat can be generated by work processes and is an essential part of some processes such as cooking. The heat
must be controlled and kept away from fuel unless carefully controlled. Heat generated as a by-product of a process
must be dealt properly.
Safeguards:
• Ensure all work equipment protects against catching fire or overheating.
• Ensure proper housekeeping, such as preventing ventilation points on machinery becoming clogged with dust or
other materials-causing overheating.
• Have electrical equipment serviced regularly by a component person to prevent sparks and fires.
• Properly clean and maintain heat producing equipment such as burners, heat exchangers, boiling (inspected and
tested yearly), ovens, stoves, and fryers. Require storage of flammables away from this equipment.
• Use a planned maintenance programme to properly maintain plant and equipment. Review your programme if you
already have one to report dangers.
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21. • Ensure employees are aware of their responsibility.
• Control sources of ignition.
• Have chimneys inspected and cleaned regularly.
• Treat independent building uses, such as an office over a shop as separate purpose groups and therefore
compartmentalize from each other.
• Ensure cooking food is always attended.
2. Oxygen: Oxygen gas is used,
• in welding, flame cutting and other similar processes
• for helping people with breathing difficulties
• in hyperbaric chambers as a medical treatment in decompression chambers
• for food preservation and packaging
• in steelworks and chemical plants
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22. The main causes of fires and explosions when using oxygen are:
• Oxygen enrichment from leaking equipment.
• Use of material not compatible with oxygen .
• Use of oxygen in equipment not desired for oxygen service.
• Incorrect or careless operation of oxygen equipment.
Safeguards: Where oxygen is used,
• Be aware of the dangers of oxygen if in doubt, ask.
• Prevent oxygen enrichment by ensuring that equipment is leak-tight and in good working order.
• Check the ventilation is adequate.
• Always use oxygen cylinder and equipment carefully and correctly.
• Always open oxygen cylinder valves slowly Do not smoke where oxygen is being used .
• Never use replacement parts which have not been specifically approved for oxygen service.
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23. • Never use oxygen equipment above the pressure certified by the manufacturer.
• Never use oil or grease to lubricate oxygen equipment.
• Never use oxygen in equipment which is not designed for oxygen service .
3. Fuel: Workplaces in which large amounts of flammable materials are displayed, stored or used can present a greater
hazard than those where the amount kept is small. In relation fire, fuel consists of flammable materials. Flammable
material is a material that burns readily in a normal atmosphere. Flammable materials include flammable liquids (e.g.,
petrol), flammable gases (e.g., propane and butane) and flammable solids (e.g., charcoal, paper). It is important to
identify all flammable materials that are in your workplace so that proper controls can be put in place.
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24. Safeguards:
• Ensure employees are aware of their responsibilities to report dangers.
• Follow the authority's advice on LPG.
• Permit no timber lining or ceiling, corridor walls/ceilings or stairways.
• Take care if placing notice boards in escape corridors/routes as any paper on the board could be fuel in the event of
fire.
• Use the code of practice for avoiding danger from underground services.
• Where there is possibility to the presence of flammable gas/vapor, conduct a full risk assessment and consider the
need for gas detection equipment.
• Where gas detection equipment is needed, ensure it is properly installed, maintained and serviced.
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25. Fire Extinguisher.
A fire extinguisher is a device which can be used to control a fire. It can help remove the fire and may stop it from
burning.
Types:
1. Water based.
2. Dry powder based.
3. Foam based.
4. Wet chemical and water additives based.
5. Carbon dioxide based.
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26. 1. Water based: Water based extinguishers are for class A fires only. In most premises, it is necessary to have either
foam or water extinguishers. It has a bright red label. This type of extinguisher is used for fires caused by various
organic materials including fabrics, textiles, coal, wood, cardboard and paper, among others. It should not be used for
kitchen fire, fires caused by flammable gas and liquids as well as fires that involve electrical equipment.
Location: These extinguishers are required to be placed by the exit on floors that have been identified for class A fire
risk.
2. Dry powder based: The standard dry powder extinguishers are also known as ABC extinguishers as these can be
used for Class A, Class B and Class C fires. However, these should not be used in enclosed spaces as the dry powder in
the extinguisher can be easily inhaled. Also, it's not easy to clean up the leftover residue once the fire is over. These
can also be used for fires involving electrical equipment. There are also special dry powder extinguishers that are
typically used for fires caused by flammable metals. The label color for this type of extinguisher is blue.
• This type of fire extinguisher may be used for fires caused by various organic materials including wood, coal, textiles,
fabrics, cardboard and paper, among others.
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27. • It may also be used for fires caused by flammable liquids including petrol and paint as well as flammable gases
including acetylene and liquid petroleum gas. Any fires that involve equipment up to 1000V may also be dealt with
the help of this fire extinguisher.
• There are special dry powder extinguishers, but these are typically used only on flammable metals such as
magnesium and titanium.
• This type of fire extinguisher should not be used for fires that involve electrical equipment over 1000 V and fires
that involve cooking oil.
Location: Garage forecourts, welding and flame cutting business and buildings with large boiler room are examples of
premises using flammable gases for chemical processes where this type of fire extinguisher is required.
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28. 3. Foam based: These are the most common type of fire extinguishers used for class B fires. However, these are water-
based which means that these can also be used for class A fires. The label color is cream.
These fire extinguishers may be used for fires caused by various organic materials including wood, coal, textiles,
fabrics, cardboard and paper among other things as well flammable liquids including petrol and paint.
This type of fire extinguisher should not be used for fires caused by flammable metals, kitchen fires and fires that
involve electrical equipment.
Foam extinguishers are needed by business and premises where the building is made from various organic materials
or in buildings where such organic materials are likely to be found including warehouses, residential properties,
hospitals, schools, offices and /buildings storing flammable liquids.
Location: This type of extinguisher should be placed by the exits on the floors that have been identified as a fire risk
for class A or class B.
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29. 4. Wet Chemical and water additives: Wet chemical and water extinguishers are designed for use on class F fires,
involving cooking oils and fats. The wet chemical fire extinguisher can also be used on class A fire, but foam or water
extinguishers are more common. Dry powder extinguishers smoothes fires by forming a barrier between the fuel and
source of oxygen. The label color for this type of extinguisher is yellow. Wet chemical extinguishers can also be used
for fires caused by various organic
materials including wood, coal, textiles, fabrics, cardboard and paper.
Location: This type of fire extinguisher needs to be placed near to the source of the fire risk in commercial kitchens
and canteens.
5. Carbon dioxide based: Carbon dioxide extinguishers are mainly used for electrical fire risks and are usually the main
fire extinguisher type provided in computer server rooms. They suffocate fires by displacing the oxygen the fire needs
to burn. This type of extinguisher has a black label.
Location: Carbon dioxide extinguishers need to be place near to the source of the fire risk or near the fire exits such as
offices, kitchens, server rooms and premises with electrical appliances and equipment.
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30. Critical Hazard Management System:
The objective of successfully implementing an HMS is the systematic management of hazards: identifying them,
assessing risks and selecting suitable control measures. Regular testing and maintenance of those controls is essential
to ensure they remain effective and for compliance.
The hazard management process: The key elements of any HMS must include:
• Identification of all hazards.
• Determining whether the hazard can be eliminated or isolated.
• Assessing the remaining hazards to determine whether they are principal hazards or significant hazards.
• Developing and introducing Principal Hazard Management Plans (PHMPs) for principal hazards.
• Developing and introducing Principal Control Plans (PCPs) for all principal control mechanisms.
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31. • For remaining hazards, where they cannot be eliminated or isolated, conducting a risk assessment to minimize the
likelihood of the hazard to workers by setting controls. This should include Standard Operating Procedures (SOPs)
and/or Trigger Action Plans (TARPS) where applicable.
• Participation of workers in the identification, assessment and control of hazards.
The hazard management system involves these three basic principles:
1. Identifying the hazard
2. Risk assessment
3. Controlling hazard
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32. 1. Identifying the hazard: The principles used for the identification of hazards and their associated risks in an
underground environment are:
a) Identification of hazards should be carried out by a team with a range of experience and expertise, including the
relevant health and safety representative.
b) A systematic approach much must be applied with sufficient detail to ensure all potential hazards are identified and
resulting risks are confidently and adequately understood.
During the process of identifying hazards, the following should be considered:
• The way work is organized, managed, carried out or changes that may occur.
• Design of workplaces, work processes, materials, plant and equipment.
• Fabrication, installation, commissioning, handling and disposal of materials, prevent the workplaces, plant and
equipment.
• Purchasing of goods and services.
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33. • Fabrication, installation, commissioning, handling and disposal of materials, prevent the workplaces, plant and
equipment.
• Purchasing of goods and services.
• Contracting and subcontracting of plant, equipment, services and labor including contract specification and
responsibilities to, and by contractors.
• Inspection, maintenance, testing, repair and replacement of plant and equipment.
Changes to established operations when changes are made to operating methods new hazards may arise. The hazard
management system should include methods for the identification of hazards arising from changes to:
• Conditions of work.
• Processes/system of work
• Resources.
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34. 2. Risk assessment: Identification and assessment of hazards, and determination of which hazards are significant hazards.
Significant hazards must then be eliminated or, if this is not practicable, isolated from the employees.
The following process should be used to determine which of the identified hazards are significant, whether they can be
eliminated or isolated, and if not, the controls required.
a) Identify and assess the nature and magnitude of all potential sources of a hazard its associated risks.
b) Assess the risks arising from each hazard, using a recognized risk management methodology.
c) The assessments should consider all relevant available information concerning the hazard and associated risks at the
underground operation.
d) Evaluate the risks by comparing the level of risk against pre- determined standards to determine the priorities to be
allocated to each risk.
e) Include any assumptions made in relation to the identification and assessment of the hazard and risks including events.
f) Identify, assess and select appropriate controls for implementation to minimize the likelihood of harm.
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35. 3. Controlling: Control for principal hazards must be documented in the HMS in the form of a principal hazard
management plan, or a 'principal control plan'. In assessing hazard and selecting controls to implement, the reasons
for adopting or rejecting those controls must also be documented.
It is advisable that controls for all other types of hazards be documented in a similar manner so that when they are
reviewed the supporting information is readily available. If a control is reviewed in such circumstances, the HMS must
also be reviewed and revised, as necessary.
Control measures often require supporting documentation, procedures, information, training, resources and testing
to make and keep them effective.
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36. The following may have to be considered when selecting appropriate controls:
• Procedures for implementing control measures during the design stage.
• Availability of competent personnel to verify that designs and modifications meet requirements.
• Purchasing and receiving procedures to ensure as per the guidelines.
• Permit to work' systems for high risk or unknown.
• Training need and changes to work procedures hazards.
• If personal protective equipment (PPE) is required, training on their correct use and maintenance.
• Supervision to check that tasks are complete and work instructions and procedures are followed.
• Records for inspection results, maintenance, repair and alteration of plant.
• Processes for identifying plant that require registration and ensuring that registration and 'fit for purpose’ is
maintained.
• Appropriate controls for working on or near plant and equipment being cleaned, aserviced, repaired or altered.
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37. • Verification that plant and equipment is safe after repair or alteration.
• Procedures for withdrawing damaged or unsafe plant and equipment from service, and
• Procedures to ensure that the workers are competent and, if required, have the appropriate licenses to operate
high risk plant.
Matters to consider when reviewing controls include:
• Are parameters and limitations known and how they can be checked?
• How do you verify the effectiveness of the control?
• What level of maintenance is requires keeping the control effective and maintenance schedule?
• What are the consequences if the control fails?
• What training/re-training is required for workers?
• How often does the control need reviewing? Has the hazard changed?
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38. THANK YOU
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