Major sources of aerosol pollution in pharmacy manufacturing premises
The major sources of pollution in manufactured medicine products are:
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Air, coming to industrial premises ..........................................20%
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Personnel (influence basically through air) ..........................30%
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Equipment and the technological process ...........................30%
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Raw and auxiliary materials .....................................................20%
Thus, the major sources and the way of pollution of maintained medicine are air and personnel, and even observing all hygiene, aseptic, antiseptic rules, there constantly are aerogene biological pollutions.
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Premise air
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Air in premises contains significant amount of pollution substances, which in most cases represent aerosols, gaseous organic and inorganic impurity and impurity of biological origin.
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Pollutant
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Typical representatives
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Suspended particulate matter
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Dust, smoke, fog
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Gases
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Sulfurs, nitrogen, carbonic oxides, other toxic gases
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Biological substances
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Bio- products, bacteria, viruses, etc.
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Considering that there always are a lot of people in premises and microclimate (temperature and humidity) creates favorable conditions for living of suspended particulate matter, impurity of premises environment is more highly than impurity of atmospheric air, especially in pathological flora.
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Quantity of microorganisms in 1 cubic m
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from 500 to several thousands
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To several tens thousands
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Personnel
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The major source of allocation and distribution of aerosol microparticles and microorganisms is personnel, besides the amount of allocated parties demands on the moving character and clothes.
By means of rules observance, using of overalls and covering for hair, it’s possible to reduce allocation and distribution of microorganisms, but you can’t avoid it.
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Particles allocation (pcs/min)
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Sedentary or standing position without movement
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Sitting position with movement of the head, hands, elbows
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Sitting position with movement of the body, hands and easy movement of feet
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Slow walking (3 – 5 km/h)
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Equipment and technological process
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The quantity of microorganisms in premise air substantially depends on people quantity, sort of their activity and from clothes kind. While supplying high quality air to the work place the amount of bacteria considerably decreases and depends on frequency air changing. As a result of increasing air changing the quantity of microbes can be lowered to zero.
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Quantity of microbes, pcs./ м3
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In the equipped condition
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In a functioning condition
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Artificial turbulent with air change:
10-12-fold/h
20-fold/h
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Easyturbulent (laminar) stream with 200-500 fold air change per hour
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Absolutely is not or individual microbes
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With air circulation increase power expenses, therefore requirements to the air clean of concrete premise, zones and other work areas should be presented taking into account practice demands and available power sources.
Low in table there are the major sources and ways of aerosol pollutions allocation in pharmacy premises with instruction main organizational-technical actions for prevention and liquidation of these pollutions.
Sources and ways of allocation
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Main actions for prevention of aerosol pollution
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Entering a pollution into premise
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Air:
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Clearing of in-coming air by equipment with high efficient filters HEPA;
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Organization of easy-turbulent (laminar) pushed out air flow;
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Maintenance of superfluous pressure in cleanrooms.
Technology:
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Regulation of an entrance/exit of the personnel, carrying in/out of raw materials, manufactured goods, etc.
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Formation of pollution indoors
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Technology:
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Application of dust-proof overalls;
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Use of technological processes not creating a dust and equipment;
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Automation of manufacture GPS, application of deserted technologies;
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Optimization of premise lay-out;Regulation of moving and personnel.
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Removal of aerosol pollution
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Air:
Technology:
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