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AIR BASED HAZARD

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• TYPES OF AIR BASED HAZARD

CONTENTS • AIR BORNE TOXICS

• INTRODUCTION TO AIR CIRCULATION

• OBJECTIVES

• APPLICATIONS

• HVAC SYSTEM

• FILTERS

• CONCLUSION

• REFERENCES

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TYPES OF AIR BASED HAZARDS

• 1.Environmental hazards : Room temperature, Ventilation,
Contaminated air

• 2.Hazardous substances :Alkali Solvents

• 3.Radiation hazards: UV, Fluorescent light ,IR

• 4.Microbiological: mishandling of cultures

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• Irritants:-various API

Ipecac:The powdered form of the former may act as a mild primary
irritant on the skin and mucous membranes, but is especially dangerous to those
who have developed an allergic sensitivity to it; asthma specifically caused by this
herb has been described (Salter, 1860; Peshkin, 1920). I have seen one nearly fatal
asthmatic seizure provoked by inhalation of very small amounts of dust from the
powdered drug.

Podophyllum.-Podophyllum root is still handled in large amounts as a
source of the benzene extract, podophyllin, a time-honoured laxative. The irritant

AIR BORNE resin which constitutes the active principle is present in sufficient amounts in the
dry powdered root to constitute a hazard. Workers who feed the root into the
grinder must be protected by goggles and dust respirators to prevent irritation

TOXICS of the mucous membranes. In exceptional cases, even the skin may be irritated by
the dust. Failure to use protective equipment results in a characteristic, very
painful conjunctivitis and keratitis, which is delayed in its onset for four to six
hours after exposure and lasts several days.

• Asphyxiants :-ts presence. , methane, ethane, hydrogen cyanide, hydrogen
sulphide, helium, nitrogen etc.,.

Carbondioxide, Carbon monoxide :is an expected by-product of certain
organic syntheses, as in the manufacture of phenylethylmalonic ester. This ester is
formed by the condensation of phenyl ethyl acetate with diethyl oxalate; when the
condensate is distilled, CO is liberated. Since the gas is quite pure and odourless, it gives
no warning.

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• Narcotics/anaesthetics :Acetone, ether, methyl-ethyl ketone etc. , chloroform dichloride.-
Chloroform and ethylene dichloride (1,2-dichloroethane) are occasionally used to extract alkaloids
and other fat-soluble principles. Both solvents are liver poisons, and men working with them under
ordinary conditions may develop certain vague symptoms which are preferable to the
gastrointestinal tract and which suggest very slight liver damage. These consist of anorexia, a heavy
feeling in the epigastrium, and fatigue.

• Local anesthetics.-The local anesthetics, procaine,butyn (butacaine sulphate), and butesin (n-
butyl aminobenzoate), form a group of substancesmore or less prone to cause sensitization and
dermatitisupon prolonged contact with the skin.

• CARCINOGENS : chromium, nickel, cobalt etc.

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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

The uncontrolled environment can lead to product degradation, loss of product, and, product contamination/ cross-
contamination.

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OBJECTIVES

▪ To understand the need for air handling system in the
pharmaceutical industry

▪ The technical requirements for the air handling system
▪ Different types of air handling system
▪ Quali f ication and val idation of HVAC system monitoring

and maintenance system

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APPLICATIONS

• Product Protection: protect from contamination, cross-contamination, prevent contamination
by operatives, correct conditions of humidity and temperature

• Personnel Protection: prevent contact with dust, prevent contact with fumes, good comfort
condition

• Environmental Protection: No dust discharge, no fumes discharge, no effluent discharge

• Preservation of materials and equipment: Handling, holding and storage

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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.

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Ducting ( for delivery of Vibration isolator (flex
Fan component

controlled air) joint)

COMPONENTS
Damper ( fixed

OF HVAC Heating and/or cooling
HEPA Filters adjustment of volume

coil
of air)

Humidity,
temperature, Pressure

Dehumidifiers Flow rate controller
sensors, alarms and

audit log system

Dust extractors

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HVAC SYSTEM

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• There are two basic concepts of clean air delivery for
pharmaceutical production to provide the need of
conditioned clean air for intended clean room

CLEAN ROOM required for manufacturing areas.

➢Full Fresh Air or Make Up Air
CONCEPT

➢Recirculation or Return Air

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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.

Clean Room Classification

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• Applicable to factory dealing with toxic products
FRESH AIR • Low risk of cross-contamination

(100%)/ ONCE • Offers abundant oxygen rich fresh air

THROUGH • Air leakage between the supply and exhaust air should be
prevented, supply air pressure should be higher than the

SYSTEM exhaust air pressure

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RECIRCULATION SYSTEM

• Requires installation of HEPA Filters in the supply air stream to remove
contaminants

AIR FLOW PATTERNS:

1. Laminar Air Flow

2. Turbulent Air Flow

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AIR FILTERS

• POSITIONING OF AIR FILTERS

✓The required cleanliness or purity of air can be achieved with effective cleaning
of the external air or recirculated through correctly designed and installed filters
to meet the specifications

• TYPES OF AIR FILTERS

✓Ultra Low Particulate Air Filter (ULPA)

✓High Efficiency Particulate Air Filter (HEPA)

✓Packed Towers

✓Membrane Filter Cartridges

✓Hydrophobic Filters
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HEPA FILTERS

• High Efficiency Particulate Air Filter
(HEPA) can remove 99.97% of particles
(dust, pollen, mold, bacteria) whose
diameter is equal to 0.3 micrometers (μm)

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HVAC PARAMETER MONITORING AND
FREQUENCY

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CONCLUSION

• The pharmaceutical production must effectively control the contamination
from people, raw materials, finished products as well as accommodating
services, process plant and equipment.

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Reference

• HEPA air pollution and control technology

• R. M. WATROUS;HEALTH HAZARDS OF THE PHARMACEUTICAL
INDUSTRY ,Abbott Laboratories.

• A.Bhatia, HVAC design for pharma industries products.

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THANK YOU

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