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STERILIZATION METHODS
Sterilization is necessary for the complete destruction or removal of all microorganisms including • spore-forming and non-spore-forming bacteria
• Viruses • fungi • Protozoa
that could contaminate pharmaceuticals or other materials and thereby constitute a health hazard.
The efficacy of any sterilization process will depend on the nature of the product, the extent and type of any contamination, and the conditions under which the final product has been prepared.
sterilization techniques using saturated steam under pressure or hot air are the most reliable and should be used whenever possible. Other sterilization methods include filtration, ionizing radiation (gamma and electron-beam radiation), and gas (ethylene oxide, formaldehyde)
The requirements for Good Manufacturing Practice should be observed throughout all stages of manufacture and sterilization.
– Classical sterilization techniques using
• Saturated steam under pressure • hot air are the most reliable and should be used whenever possible. • Filtration • Ionizing radiation (gamma and electron-beam radiation) • Gas (ethylene oxide, formaldehyde)
Physical method for sterilization
Chemical method for sterilization
Biological indicators of sterilization
Periodic revalidation
bioindicator strainoxidation of cell constituents
1. Heating in an autoclave (steam sterilization) -oxidation of cell constituents.
2. . Dry-heat sterilization - saturated steam under pressure in an autoclave, PRINCIPLES OF STEAM STERILIZATION
3.Filtration- membrane filters (cellulose derivatives, etc.), o plastic filters o porous ceramic, or suitable sintered glass filters, or combinations of these. o Asbestos- containing filters should not be used.
4. Exposure to ionizing radiation- active ingredients, drug products, and medical devices
5. Gas sterilization- ethylene oxide, formaldehyde or another highly volatile substance.

Process of Microbial Destruction
Microbial Death Kinetics
Bioburden
D value
Sterility Assurance Level (SAL)
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