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

Physical method

Heat Radiation

Dry heat Moist heat

Autoclave

STERILIZATION / DISINFECTION

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DRY HEAT STERILISATIONDRY HEAT STERILISATIONIncineration Incineration Over bakingOver baking

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MOIST HEAT STERILISATIONMOIST HEAT STERILISATIONAutoclavingAutoclavingBoiling Boiling

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RADIATIONRADIATIONIt is of two type that is It is of two type that is

1.1.Ionize radiationIonize radiation

2.2.Nonionizing radiationNonionizing radiation

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FILTRATIONFILTRATIONMembrane 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.

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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

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VIBRATIONVIBRATIONSound 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.

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CHEMICAL STERILISATIONCHEMICAL STERILISATION ETHYLENE OXIDEETHYLENE OXIDE FORMAL DEHYDEFORMAL DEHYDE BETAPROPIOLACTONEBETAPROPIOLACTONE

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ETHYLENE OXIDEETHYLENE OXIDEIt 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.

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USEUSEIt is to sterilize rubber and plastic It is to sterilize rubber and plastic materialmaterial

DISADVANTAGE.DISADVANTAGE.

highly toxic,iritate eyehighly toxic,iritate eye

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FORMAL DEHYDEFORMAL DEHYDEIt use to disinfect interiors of the It use to disinfect interiors of the room.room.In high concentration sporicidal.In high concentration sporicidal.

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BETAPROPIOLACTONEBETAPROPIOLACTONEIt’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.

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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.

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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

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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

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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.

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REFERENCESREFERENCES Sharma P.P; How to practice GMPs; (Good Manufacturing Sharma P.P; How to practice GMPs; (Good Manufacturing Practices); Fourth Edition ; Vandana Publication pvt. Ltd. Practices); Fourth Edition ; Vandana Publication pvt. Ltd. Delhi. pp-208-280Delhi. pp-208-280

Potdar M.A ; cGMP; (Current Good Manufacturing Practices) Potdar M.A ; cGMP; (Current Good Manufacturing Practices) For Pharmaceuticals; Pharma Med Press; Hyderabad-500095. For Pharmaceuticals; Pharma Med Press; Hyderabad-500095. pp-339-384pp-339-384

Shah D.H.; SOP Guidelines; straight and simple; 1Shah D.H.; SOP Guidelines; straight and simple; 1stst edition; edition; published by Business Horizons;G-59, New Delhi-110048, pp-published by Business Horizons;G-59, New Delhi-110048, pp-161-183.161-183.

Mallik V; Drugs& Cosmetics Act 1940; 18Mallik V; Drugs& Cosmetics Act 1940; 18thth edition;2005; edition;2005; published by Eastern Book Company; Lucknow.published by Eastern Book Company; Lucknow. 1919

2020