Is lyophilization a sterilization process too

Dear All
pls tell me .

with proper justification
is lyophilization a sterilization process too?

Sterilization is a process where the product is rendered sterile that means all the Bioburden load is eliminated by killing by means of Dry heat sterilization, Moist heat sterilization , Radiation sterilization and by means of filtration which is no thermal or energy based.Technically it is for products and process material where the material charecterestics are not altered or modified.

Lyophilization process is not sterilization process. It is a process where the liquid product is cooled below its Eutectic point, freezed, vacuum is applied to remove water from the product by means of sublimation process, then product is slowly brought to room or desired temperature so that product is solidified in to a more stable compound rather than non-stable liquid form. The main reason performing this process is to increase the shelf stability of products. Some chemical products and Biological products are not stable in liquid forms.Such products are lyophilised to remove water.

Comming back to your question: If any bacteria is present in the product and if it is lyophilised and when the product is reconstituted with a solvent or water most of times, the bacteria will grow back. 99.92% times bacteria will not be killed or eliminated. No where in the research it was proved or written or observed Lyophilization is a sterilization methodology.

“Lyophilization is a process applied for formulation of Pharmaceutical, Bio-pharmaceutical, Food products and Preservation of Microbial and Recombinant Microbes/cells etc”.

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