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BACKGROUND
Sterility testing of all pharmaceutical product is done to expose the presence of any feasible forms of bacteria, fungus or yeasts. Therefore, all pharmaceutical products are marked sterile only after they have successfully undergone the process of sterilization. The basic objective of this test is to treat the pharmaceutical products for sterility.
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REQUIREMENTS
Equipments: Laminar air flow
Apparatus: Forceps
Scissors
Sample: Membrane filter
Sterile solution
Sterile plates
Sterile swab
Gas burner
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PROCEDURE
At first carefully access the contents of the product after cleaning the outside off the closings and containers. If it is vacuum packed then allow sterile air. For sampling 20 units of each medium is tested. For testing you can follow two methods.1
Membrane filtration
Filters usually made from either esters or a mixture of esters and cellulose with 0.45micrometer and 50mm diameter is used. Prepare for the sterilized filter assemble or alternatively you can cut the filter paper into pieces and put it in culture media and then incubate for about 7 days.
Direct inoculation
For liquid samples, 10-fold dilution is done and for solid samples100 folds dilution is done by using a very suitable diluent. A larger volume is used for antimicrobial activity elimination. Then it is incubated for about 14 days.
If growth occurs after incubation period then it is not a sterile product and no growth implies a sterile product.
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CONCLUSION
Thus, by doing this test we will get sure if the product is perfectly safe or not.
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REFERENCES
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Bowman FW. J Pharm Sci, Wiley Online Library. 1969.
