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Pharm D- Clinical Pharmacy Program Third Level Pharmaceutical Microbiology& Antimicrobials (PM 502)
LAB 5
Sterility test
Definitions:
• Sterile product: Product which is free from all forms of living beings as
viruses, fungi, bacteria and parasites. So, sterility test should be done to detect
its sterility (absence or presence of microorganisms).
• Sterilized product: product that passes sterilization process but it is not sure
whether it is sterile or not.
• Batch: number of units subjected to the same sterilization conditions. Ex:
penicillin powder batch.
• Batch number indicates which method applied for sterilization of the product.
Significance of sterility test:
Sterility test is performed to test absence or presence of microorganism (sterility
of the object).
Principles of sterility test:
1- Specialized media inoculated with specific amount of material under test and
incubated at specific temperature.
2- Test carried on: bacteria (aerobic and anaerobic), fungi and yeasts.
3- Results of the test may show:
a) No growth and so material pass the test.
b) Growth and in such case the material fails the test.
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