DIPAK KUMAR DASH
PRODUCTION OFFICER
MARCK BIOSCIENCE
GOA
11
DISINFECTION & STERILIZATION
STERILIZATION
Process of
removing microbes
inclusive of
bacterial
endospores.
DISINFECTION
process of
removing microbes
except bacterial
endospores.
2
RADIATIONRADIATION
It is of two type that is It is of two type that is
1.1.Ionize radiationIonize radiation
2.2.Nonionizing radiationNonionizing radiation
66
FILTRATIONFILTRATION
Membrane filter with pore size Membrane filter with pore size
between o.2 to 0.45 micrometer.between o.2 to 0.45 micrometer.
Use for heat labile liquid.Use for heat labile liquid.
Ex-serum, anti biotic sol.Ex-serum, anti biotic sol.
77
TYPE OF FILTER ARETYPE OF FILTER ARE
1.1.EARTHENWARE FILTERSEARTHENWARE FILTERS
2.2.ASBESTOS FILTERASBESTOS FILTER
3.3.SINTERED GLASS FILTERSSINTERED GLASS FILTERS
4.4.MEMBRANE FILTERSMEMBRANE FILTERS
5.5.AIR FILTERSAIR FILTERS
88
VIBRATIONVIBRATION
Sound waves of frequency >20,000 Sound waves of frequency >20,000
cycle/second kills bacteria and some cycle/second kills bacteria and some
viruses exposing for one hour.viruses exposing for one hour.
Use to disinfect instrument.Use to disinfect instrument.
99
ETHYLENE OXIDEETHYLENE OXIDE
It is an alkylating agent.It is an alkylating agent.
It act by alkylating sulphydryl,amino, It act by alkylating sulphydryl,amino,
carboxyl groups.carboxyl groups.
It is highly flammable since it is use in It is highly flammable since it is use in
mixture with carbon dioxide.mixture with carbon dioxide.
1111
USEUSE
It is to sterilize rubber and plastic It is to sterilize rubber and plastic
materialmaterial
DISADVANTAGE.DISADVANTAGE.
highly toxic,iritate eyehighly toxic,iritate eye
1212
FORMAL DEHYDEFORMAL DEHYDE
It use to disinfect interiors of the It use to disinfect interiors of the
room.room.
In high concentration sporicidal.In high concentration sporicidal.
1313
BETAPROPIOLACTONEBETAPROPIOLACTONE
It’s a sporicidal product at a conc. of It’s a sporicidal product at a conc. of
1.5 mg/kg.1.5 mg/kg.
1414
DisinfectantDisinfectant
Disinfectant are the substance that Disinfectant are the substance that
are applied to non living objects to are applied to non living objects to
destroy microorganism.destroy microorganism.
It is less effective than sterilization.It is less effective than sterilization.
1515
Commonly used Commonly used
disinfectantdisinfectant
1.1.AlcoholAlcohol
2.2.phenolphenol
3.3.ChlorhexaneChlorhexane
4.4.GlutaraldehydeGlutaraldehyde
5.5.Povidon-iodinPovidon-iodin
6.6.chloroformchloroform
1616
SURFACE SURFACE
DISINFECTIONDISINFECTION
Agents that damage bacterial cell Agents that damage bacterial cell
membranes may be used to disinfect membranes may be used to disinfect
inert surfaces or skin.inert surfaces or skin.
Ex Ex
detergents,alcoholdetergents,alcohol
1717
CONCLUSIONCONCLUSION
All sterilization processes must be All sterilization processes must be
validated.validated.
These process should be care fully These process should be care fully
done for effective product.done for effective product.
1818
REFERENCESREFERENCES
Sharma P.P; How to practice GMPs; (Good Manufacturing Practices); Fourth Sharma P.P; How to practice GMPs; (Good Manufacturing Practices); Fourth
Edition ; Vandana Publication pvt. Ltd. Delhi. pp-208-280Edition ; Vandana Publication pvt. Ltd. Delhi. pp-208-280
Potdar M.A ; cGMP; (Current Good Manufacturing Practices) For Potdar M.A ; cGMP; (Current Good Manufacturing Practices) For
Pharmaceuticals; Pharma Med Press; Hyderabad-500095. pp-339-384Pharmaceuticals; Pharma Med Press; Hyderabad-500095. pp-339-384
Shah D.H.; SOP Guidelines; straight and simple; 1Shah D.H.; SOP Guidelines; straight and simple; 1
stst
edition; published by edition; published by
Business Horizons;G-59, New Delhi-110048, pp-161-183.Business Horizons;G-59, New Delhi-110048, pp-161-183.
Mallik V; Drugs& Cosmetics Act 1940; 18Mallik V; Drugs& Cosmetics Act 1940; 18
thth
edition;2005; published by edition;2005; published by
Eastern Book Company; Lucknow.Eastern Book Company; Lucknow.
1919