Sources, Types of Hazards, Air circulation maintenance industry for sterile area and non sterile area, Preliminary Hazard Analysis (PHA)

1. AIR BASED HAZARD
 Present By: SATISH , KARISHMA ,
MAYUR .
 F. Y. M. Pharm (QA Department)
 ROLL NO : QA 04 ,05 ,06.
 Shri. D. D. Vispute College of
Pharmacy and Research Center
 Guided By:
 Prof. Mukesh Subhash Patil
 Shri. D. D. Vispute College of
Pharmacy and Research Center

2. INTRODUCTION
A hazard is any source of potential damage, harm or
adverse health effect on something.
Or something which could be dangerous to you,
your health, or safety.
AIR BASED HAZARDS include air pollution also.

3. AIR POLLUTION
Air pollution can be defined as the presence of toxic
chemicals or compounds in the air, at certain level
that pose 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.

4. SOURCES OF AIR POLLUTION
• Sources of Energy generation
• Land mining
• Agricultural practices
• Burning of wastes
• Burning of wastes
• Natural sources

5. SOURCES OF AIR BASED HAZARDS
• Pesticides
• Refineries
• Chemical industry
• Forest fires
• Transportation
• Energy production

6. EFFECTS OF AIR POLLUTION
• Effects on Human Health:
CHRONIC:long duration exposure and/or
long term effects
Examples:lung cancer, heart disease, damage to
brain, nerves,liver, kidneys, etc.

7. EFFECTS OF AIR POLLUTION ON PLANTS:
• Decrease yield in agriculture.
• Suppressed growth of vegetables.
• Leaf injury and damage to young plants.
• Decreased growth rate and increased death rate.

8. CONTROL OF AIR POLLUTION
Prevention is always better than cure.
• Planting trees.
• Reducing vehicle exhausts.
• Using less pollution fuels.
• Using mass transport.
• Industrial area should be cited far away from residential area.
• Use of tall chimneys reduces- concentration of air pollutants at ground level.

9. TYPES
• Indoor Pollution
• Outdoor Pollution

10. INDOOR POLLUTION
• It is the pollution that occurs inside our homes, schools, office.
• The main sources of indoor pollution are tobacco smoke, gases from
stoves and furnace, household chemicals, small fibre particles,
hazardous fumes given off by building material like insulation, glue
and paint, chemicals from cleaning products, wall paint, air
fresheners, etc.
• 80% of the World population is affected by Indoor pollution.

11. OUTDOOR POLLUTION
• Outdoor air is often referred to as ambient air.
• The common sources of outdoor pollution are vehicle exhaust, emission from
industries, smoke from bushfires, etc.
• The most common air pollutant of ambient air include:
1. Ozone
2.Nitrogen dioxide
3.Carbon monoxide
4.Sulphur dioxide

12. • Several pollutants are mixed in the air and a large portion of the world population
is regularly exposed to harmful air.
Various types are:
• SMOG
• Particle pollution
• Greenhouse effect
• Natural air pollution

13. AIR CIRCULATION MAINTENANCE
INDUSTRY FOR STERILE AND NON
STERILE AREAS

14. INTRODUCTION
• Air circulation system plays a major role in the quality of pharmaceutical product
manufacturing( 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.

15. OBJECTIVE
• 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

16. APPLICATIONS
1. Product protection: protect from contamination , cross contamination, prevent
contamination by operatives, correct conditions of humidity and temperature.
2. Personnel protection: prevent contact with dust, prevent contact with fumes,
good comfort condition.
3. Environment protection: No dust discharge, no fumes discharge, no effluent
discharge.
4. Preservation of materials and equipment Handling, holding and storage

17. HVAC SYSTEM
• 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.
• COMPONENT OF HVAC :
Ducting ( for delivery of controlled air).
 Fan component.
Vibration isolator (flex joint).

18.  Heating and /or cooling coil.
HEPA Filters.
Damper ( fixed adjustment of volume of air).
 Dehumidifiers.
Flow rate controller.
Humidity, Temperature, Pressure sensors, alarms and audit log system.
Dust extractors

19. HVAC SYSTEM

21. CLEAN ROOM CONCEPT
• There are two basic concepts of clean air delivery for pharmaceutical production
a. Full Fresh air or Make up air.
b. Recirculation or Return air.
• All to provide the need conditioned clean air for intended clean room required for
manufacturing areas.
 What is clean area/ room/space?
• A closed room supplied with filtered ( purified air ) in which the particulate and
microbial contamination load is below specified level. And is used in such a way
to minimise introduction, generation and retention of contaminants.

22. CLEAN ROOM CLASSIFICATION
Class Product
A (10) Sterile preparation / injectables
B (100) Sterile preparation / injectables
C (1000) Topical and oral liquids
D (10000) Tablet
 Clean rooms classification differs for sterile and non sterile and can be
classified as such:
• Non sterile operations/controlled or non aseptic.
• Sterile operation/critical areas/aseptic applications.

23. FRESH AIR ( 100%)/ONCE THROUGH SYSTEM
• Applicable to factory dealing with toxic products.
• Low risk of cross contamination.
• Offers abundant oxygen rich fresh air for dilution of contaminants.
• Air leakage between the supply and exhaust air should be prevented, supply air
pressure should be higher that the exhaust air pressure .

24. RECIRCULATION SYSTEM
• Requires installation of HEPA filters in the supply air stream to remove
contaminants.
 AIR FLOW PATTERN:
a. Laminar air flow
b. Turbulent air flow

26. AIR FILTERS
 POSITIONING OF FILTERS: The required cleanliness or purity of air can
be achieved with effective cleaning of the external air or recirculated air
through correctly designed and installed filters to meet the specification.
• Types of air filters :
Ultra Low Particulate Air filter( ULPA)
High Efficiency particulate air filter( HEPA)
Packed towers
Membrane filter cartridges
Hydrophobic filters

28. HEPA FILTERS
• HEPA is an acronym for “High Efficiency Particulate Air”.
• This type of air filter can remove at least 99.97% of dust, pollen, mold, bacteria
and any airborne particles with a size of 0.3 micrometres (μm).

30. TYPES OF HEPA
FILTERS

31. Sr no PARAMETERS FREQUENCY
1 HEPA Filter Integrity (
DOP testing)
Annual / Yearly ( 12
monthly)
2 Air Change rate 6 months( biennially)
3 Air pressure differential Daily
4 Microbial load ( settle
plate & Swabs)
Daily
5 Temperature Daily
6 Humidity ( Relative
Humidity)
Daily
HVAC PARAMETER MONITORING AND
FREQUENCY

32. AIR CONDITIONING
• It is the process of treating the air so as to control its temp., humidity, cleanliness
and distribution simultaneously to meet the requirements of the conditioned
space.
• Applications:
Promoting the human comfort.
Maintenance of proper conditions for manufacture, processing and preserving of
material and equipment.
Environmental test chamber.
Maintenance of animal and equipment

34. TYPES OF EQUIPMENT
1.Self contained air conditioner/ Unitary/ Packaged
2.Central air conditioner/ Field erected
1.Self contained air conditioner/ Unitary/ Packaged:
 These system include window mounted or wall bracket conditioners.
 Most of this units are air cooled through water cooled type.
 Room air enters the casing at the front panel.
 It is mixed with part of the outdoor air and this mixture is forced over a cooling
coils by a centrifugal fans.

35. 2. Central air conditioning system:
 In this system one or several areas are air conditioned by duct
network.
Air cleaning is done by filters.
Cooling is achieved by using water or by direct expansion in
refrigerated coils or air washers.
Heating is achieved by using steam or hot water coils.

36. FIRE HAZARDS
• Fire: The self-sustaining process of rapid oxidation of a fuel which produces heat
and light.
• Fire is an exothermic chemical reaction between oxygen and fuel at certain
temperature.
• Three things essential for the combustion of fire are,
1. Fuel (any combustible material)
2. Oxygen (At concentrations above 23 % in air, the situation becomes dangerous
due to the increased fire hazard)
3. Temperature.

37. PREVENTION OF FIRE HAZARDS
• Well planned design and layout
• Proper ventilated systems
• Chemical data sheets
• Proper training of personnel
• Proper maintenance of surroundings
• use of fire extinguishers, alarms ,sensors, detectors
• Fire fighting equipment
• Sprinkler systems

38. PREVENTIVE MEASURES
• Prohibition of smoking in manufacturing areas.
• Oxygen present in the inflammable atmosphere may be ↓by dilution with gases
such as nitrogen, co2,steam or combination of these.
• Hazardous operation should be isolated
• Eliminating the ignition sources
• Using fire resistant material in construction
• Suitable emergency exits
• Adequate venting

39. FIRE & EXPLOSION HAZARDS
• Automatic sprinklers
• Equipment should design to meet the specifications & code of recognized
authorities, such as ISA, API &ASME
• The design & construction of pressure vessels & storage tanks should follow API
& ASME codes.
• Inspection

40. FIRE SUPRESSION
It is done by using hydrant systems/water sprinkler systems and fire extinguishers.
• Hydrant systems include
1. Water sprinklers
2. Semi automatic hydrant system
3. Automatic sprinkler and
4. Manually hydrant system.

41. FIRE EXTINGUISHER
 A Fire extinguisher is a device which can be used to
control a fire.
Fire extinguishers can help remove the fire, and may stop
it from burning.

42. THINGS TO REMEMBER BEFORE INSTALLATION OF
FIRE EXTINGUISHERS :
 Brass Valve Chrome Plated Heavy duty
 BIS Approved
 CE Certified.
 Maintenance should be done as per IS 2190:2010
 Must Check the color band according to need.
 Extinguisher/ Equipments must be according to guidelines given
by
concerned disaster authority

43. TYPES OF FIRE EXTINGUISHER
1. Water Extinguishers
2. Carbon Dioxide (CO2) Extinguishers
3. Dry Powder Extinguishers
4. Wet Chemical Extinguishers
5. Foam Extinguishers
6. Clean Agent Extinguisher

44. 1] WATER EXTINGUISHER
 Water extinguishers are the most common fire extinguisher type for
class A fire risk. Most premises will require either water or foam
extinguishers.
 Label Color : Bright Red
 Use for :
Organic materials such as:
 Paper and cardboard
 Fabrics and textiles
 Wood and coal

45. Do not use for: - Fires involving electrical equipment , Kitchen fire ,
Flammable gas and liquids.
How water extinguishers work: The water has a cooling effect
on the fuel, causing it to burn much more slowly until the flames are
eventually extinguished.
Types of premises/business who may need water
extinguishers: -
 Buildings constructed of wood or other organic materials
 Premises where there are organic materials to be found such as:
offices , Schools ,Hospitals, Residential properties,
Warehouses.

46. 2] CARBON DIOXIDE (CO2) EXTINGUISHERS
 CO2 extinguishers are predominantly used for electrical fire risks
and are usually the main fire extinguisher type provided in computer
server rooms. They also put out Class B fires (flammable liquids,
such as paint and petroleum).
 Label Color : Black
 Use for : -
 Flammable liquids, like paint and petrol
 Electrical fires

47.  Do not use for : Kitchen fires, Fires ,combustible materials like
paper, wood , Flammable metals.
 How CO2 extinguishers work : CO2 extinguishers suffocate fires
by displacing the oxygen the fire needs to burn.
 Types of premises/business who may need CO2
extinguishers:
 Premises with electrical equipment such as:
offices , Kitchens, Construction sites, Server rooms.

48. 3] DRY POWDER EXTINGUISHERS
 Standard dry powder extinguishers are also called 'ABC' extinguishers because
they tackle class A, B and C fires, however they are not recommended for use in
enclosed space because the powder can be easily inhaled, and also the residue
is very difficult to clean up after.
 Label Color: Blue
 Use For :
 Paper and cardboard
 Fabrics and textiles
 Wood and coal, paints,
 Flammable gases.

49.  Do not use for : Fires involving cooking oil , Fires involving electrical
equipment over 1000v , or in enclosed spaces, such as offices or residential
properties.
 How dry powder extinguishers work : Dry powder extinguishers smother fires
by forming a barrier between the fuel and the source of oxygen.
 Types of premises/business who may need Dry Powder extinguishers :
Businesses using flammable gases for chemical processes, Premises where
welding and flame cutting takes place ,Garage forecourts ,Liquid petroleum gas
(LPG) dispensing plants, Premises with large, commercial boiler rooms.
 Where to locate Dry Powder extinguishers : Place dry powder extinguishers
near to the source of the fire risk.

50. 4] WET CHEMICAL EXTINGUISHERS
 Wet chemical extinguishers are designed for use on Class F Fires, involving
cooking oils and fats. They can also be used on Class A fires although it is more
usual to have a foam or water extinguisher for this type of fire risk.
 Label Color: Yellow
 Use for:
 Cooking oil/fat fires
 Organic materials such as:
 Paper and cardboard
 Fabrics and textiles
 Wood and coal

51.  Do not use for: - - Flammable liquid or gas fires
- Electrical fires
- Flammable metals
 How wet chemical extinguishers work:
Wet chemical extinguishers create a layer of foam on the surface of the
burning oil or fat, preventing oxygen from fuelling the fire any further. The spray also
has a cooling effect.
 Types of premises/business who may need wet chemical extinguishers:
- Commercial kitchens
- Canteens Privacy
 Where to locate wet chemical extinguishers: -
- Place near to the source of the fire risk.

52. 5] FOAM EXTINGUISHER
 Foam has the ability to form an aqueous film which quickly over water-insoluble
hydrocarbon fuel surfaces causing rapid fire extinguishment and vapour
suppression for class B fires. Also it provides excellent penetrating and wetting
qualities when used on class A fires.
 Color Band- Yellow
 Used in-
 Paints, Lubricants, Chemical Industry,
 Oil Fire/Refinery, Kitchen/Restaurant, Boiler Room.
 Do not use on electrical fire.

53.  CLEAN AGENT replaces Halon 1211 as the agent of choice for application
where the agent must be clean,electrically,non-conductive, environment-friendly,
extremely low in toxicity and exceptionally effective. Suitable for Class A,B and C
fires
 Color Band - Green
 Useful in -
Computer rooms,Laboraties,
 Essential communication Area,
 Server-data Room/Tele- communication area,
Serve-data Room/Tele- communication
6] CLEAN AGENT EXTINGUISHERS

54. CRITICAL HAZARDS MANAGEMENTS
 HAZARDS means an activity ,arrangement
,circumstances,event,occurrence,phenomena, process, situation and
substance(whether arising or caused within or outside a place of work) that is
actual or potential cause or source of harm.
 HAZARDS MANAGEMENT is essentially a problem-solving process (
identifying hazards),gathering information about them (assessing the risks) and
solving them (controlling the hazards).

55. STEPS OF CRITICAL HAZARDS MANAGEMENT
IDENTICATION OF HAZARDS
RISK ASSESSMENT
HAZARD CONTROL
RISK CONTROL
EVALUATE MONITOR AND REVIEW

56. 1. IDENTIFICATION OF HAZARDS
 This is the fundamental step in hazard management.
 Some ways of identifying hazards:
• Workplace inspection
• Incident reporting
• Register of injuries
• Consultation with employees
• Feedback from employees

57. 2] RISK ASSESMENT
 When you identified the hazards , you need to assess the risk created by each
hazard.
 The risk is the likelihood that the hazard will cause injury, illness or decrease in
the way that the hazard will cause injury, illness, or diseases in the way that it is
used or occurs in the workplace and the severity of the injury, illness or diseases
that may results.

58. 3] HAZARD CONTROL
 It is enough to just find and rate the hazards.
 After finding the hazards it is important to eliminate or control the hazard before
the injury or illness of people due to hazard.

59.  RISK CONTROL
 Risk control is also called as hazard control, is a part of hazards management.
 It can be define as the methods for neutralizing or reduction of identified hazards
are implemented.

60. 4] EVALUVATE, MONITOR AND REVIEW
 It is important to know if your risk assessment was complete and accurate.
 It is also essential to be sure that changes in the workplace have not introduced
new hazards or changed hazards that were once ranked as lower priority to
higher priority.

61. KEEP RECORDS
 Keeping records of your assessment and any control actions taken is very
important. You may be required to store assessments for specific number of
years.
 Check for local requirements in your jurisdiction. The level of documentation or
record
 keeping will depend on:
 Level of risk involved
 Legislated requirements
 Requirements of any management systems that may be in place.

62. PRELIMINARY HAZARD ANALYSIS
Preliminary hazard analysis (PHA) 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 events according to their severity
• Identify required hazard controls and follow-up actions

63. PURPOSE OF PHA ?
The purpose of PHA is:
• Often used to evaluate hazards early in the life of a process
• Generally applied during the conceptual design or R & D phase of a process
plant
• Commonly used as a design review tool before a process P & ID is developed.
P&ID (Piping and Instrumentation Diagram) is a schematic illustration of functional
relationship of piping, instrumentation, and system equipment components

64. The PHA shall consider:
❑ Hazardous components
❑ Safety related interfaces between various system elements, including software
❑ Environmental constraints including operating environments
❑ Operating, test, maintenance, built-in-tests, diagnostics, and emergency procedures
❑ Facilities, real property installed equipment, support equipment, and training
❑ Safety related equipment, safeguards, and possible alternate approaches
❑ Malfunctions to the system, subsystems, or software
PHA SCOPE

65. PHA STEPS :
1. PHA prerequisites
2. Hazard identification
3. Frequency and consequence estimation
4. Risk ranking and follow-up actions

66. PHA PREREQUISITE
1. Establish PHA team
2. Define and describe the system to be analyzed
(a) System boundaries (which parts should be included and which should not)
(b) System description; including layout drawings, process flow diagrams, block diagrams, and
so on
(c) Use and storage of energy and hazardous materials in the system
(d) Operational and environmental conditions to be considered
(e) Systems for detection and control of hazards and accidental events, emergency systems, and
mitigation actions
3. Collect risk information from previous and similar systems
(e.g., from accident data base

67. HAZARD IDENTIFICATION
Hazard is a physical or chemical characteristic of a material,
system, process, or plant that has the potential for causing harm.

68. COMMON SOURCES OF HAZARDS
Common sources of hazards are:
❑ Sources and propagation paths of stored energy in electrical, chemical,
or mechanical form
❑ Mechanical moving parts
❑ Material or system incompatibilities
❑ Nuclear radiation
❑ Electromagnetic radiation (including infra-red, ultra-violet, laser, radar,
and radio frequencies)
❑ Collisions and subsequent problems of survival and escape
❑ Fire and explosion

69. FREQUENCYAND CONSEQUENCE
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.

71. WHICH CONSEQUENCES SHOULD BE
CONSIDERED ?
• 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.

72. RISK RANKING AND FOLLOW-UPACTIONS
The risk is established as a combination of a given event/consequence and a
severity of the same event/consequence.
This will enable a ranking of the events/consequences in a risk matrix as
illustrated below:

74. EACH ENTRY IN THE PHA WORKSHEET MAY BE GIVEN A
SPECIFIC RISK
LEVEL, FOR EXAMPLE, AS

75. PHA PROS AND CONS
Pros:
❑ Helps ensure that the system is safe
❑ Modifications are less expensive and easier to implement in the earlier stages of
design
❑ Decreases design time by reducing the number of surprises
Cons:
❑ Hazards must be foreseen by the analysts
❑ The effects of interactions between hazards are not easily recognized

76. REFERENCE
1. https://www.slideshare.net/mb3594/air-based-hazard
2. https://www.slideshare.net/AshvinBhoge/air-based-hazards
3. https://www.slideshare.net/mb3594/air-based-hazard
4. HVAC Design for Pharmaceutical Products, A. Bhatia.
5. 2. HVAC Basics; Vishal Katyar.
6. 3. AIR HANDLING SYSTEM IN PHARMACEUTICAL MANUFACTURING by
R.A.BINITIE.
7. 4.Maintanance of sterile area /authorstream.
8. 5. Mikhail Kitain CLEANROOMS IN PHARMACEUTICAL PRODUCTION.
9. 6.HEPA air polution control technology .
10. https://www.slideshare.net/vaibhavmudga8/fire-extinguishers-62268667
11. http://www.slideshare.net/AmrutaBalekundri/critical-hazard-management-system-
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