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DIPAK KUMAR DASH
PRODUCTION OFFICER
MARCK BIOSCIENCE
GOA

1
DISINFECTION & STERILIZATION


STERILIZATION
Process of
removing microbes
inclusive of
bacterial
endospores.

 DISINFECTION

process of
removing microbes
except bacterial
endospores.

2
STERILIZATION / DISINFECTION
Physical method

Heat

Radiation

Moist heat

Dry heat

Autoclave

3
DRY HEAT STERILISATION
Incineration
Over baking


4
MOIST HEAT STERILISATION
Autoclaving
Boiling


5
RADIATION
It is of two type that is
1.Ionize radiation
2.Nonionizing radiation

6
FILTRATION
Membrane filter with pore size
between o.2 to 0.45 micrometer.
Use for heat labile liquid.
Ex-serum, anti biotic sol.


7
TYPE OF FILTER ARE
1.
2.
3.
4.
5.

EARTHENWARE FILTERS
ASBESTOS FILTER
SINTERED GLASS FILTERS
MEMBRANE FILTERS
AIR FILTERS

8
VIBRATION
Sound waves of frequency >20,000
cycle/second kills bacteria and some
viruses exposing for one hour.
Use to disinfect instrument.


9
CHEMICAL STERILISATION




ETHYLENE OXIDE
FORMAL DEHYDE
BETAPROPIOLACTONE

10
ETHYLENE OXIDE
It is an alkylating agent.
It act by alkylating sulphydryl,amino,
carboxyl groups.
It is highly flammable since it is use in
mixture with carbon dioxide.


11
USE
It is to sterilize rubber and plastic
material
DISADVANTAGE.
highly toxic,iritate eye


12
FORMAL DEHYDE
It use to disinfect interiors of the
room.
In high concentration sporicidal.


13
BETAPROPIOLACTONE
It’s a sporicidal product at a conc. of
1.5 mg/kg.


14
Disinfectant
Disinfectant are the substance that
are applied to non living objects to
destroy microorganism.
It is less effective than sterilization.


15
Commonly used
disinfectant
1.
2.
3.
4.
5.
6.

Alcohol
phenol
Chlorhexane
Glutaraldehyde
Povidon-iodin
chloroform
16
SURFACE
DISINFECTION
Agents that damage bacterial cell
membranes may be used to disinfect
inert surfaces or skin.
Ex
detergents,alcohol


17
CONCLUSION




All sterilization processes must be
validated.
These process should be care fully
done for effective product.

18
REFERENCES
Sharma P.P; How to practice GMPs; (Good Manufacturing Practices); Fourth
Edition ; Vandana Publication pvt. Ltd. Delhi. pp-208-280


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

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

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

19
20

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