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STERILITY TEST.pptx

The presentation describes evaluation of sterility of parenteral products. It contains principle, methods, media selection and result interpretation of sterility test. carried out for pharmaceutical sterile products.

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STERILITY TEST OF
PHARMACEUTICAL PRODUCTS
Mr. A.T. Sharma
Assistant Professor
Department of Pharmaceutics
Nanded Pharmacy College,
Nanded
Principle:
• Sterilization: Is the process of making something
free from bacteria or other living microorganisms.
• Sterility Testing: Are done to detect if viable forms
of micro-organisms are present or not on or in the
pharmaceutical preparations.
Which products undergo sterility tests?
The test is applied to substances or preparations which, according to the
Pharmacopoeia, are required to be sterile. For example
✦ Injections
✦ Implants
✦ Syringes
✦ Bandages
✦ Dressings
✦ Surgical Instruments
✦ Needles
✦ Injectables
✦ Bulk Solids
✦ Ophthalmic Products etc
• If microorganisms are placed in a media that provides
nutrients and water and kept at a favourable temperature
the organism will grow and their growth can be indicated
by turbidity in originally clear medium.
• The sterility tests provide optimum conditions for the
growth and multiplication of organisms, spores, etc. that
might be a contaminant.
• It is not possible to claim that a batch of products is
sterile unless the entire content of each batch has been
tested.
• But these conditions are not possible because the article
or the preparation under test is either made unstable (like
a syringe) or is destroyed (like an injectable solution).
• Thus only a part of the batch can be sampled for testing.
MEMBRANE FILTRATION METHOD
• Membrane has a nominal pore size not greater than 0.45
micron and diameter of approximately 50mm.
• This method basically involves filtration of sample through
membrane filters.
• The filtration is assisted under Vacuum after filtration
completion the membrane is cut into 2 halves and one halve
is placed in two test tubes containing FTM, SCDM medium.
• Incubate the media for not less than 14 days.
Used for: ‣An oil or oily preparation.
‣Ointments that can be put into solutions.
‣Soluble powder.
‣Liquid products where volume in a container is 100ml or
more.
‣Non bacteriostatic solid not readily soluble in culture media.
Culture Media:
For both AEROBES and ANAEROBES:
Fluid Thioglycolate Media
Alternate Fluid Thioglycolate Media
For detection of AEROBIC and FUNGI:
Soybean Caesin Digest Media, Sabourould’s Dextrose
Agar Media

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STERILITY TEST.pptx

  • 1. STERILITY TEST OF PHARMACEUTICAL PRODUCTS Mr. A.T. Sharma Assistant Professor Department of Pharmaceutics Nanded Pharmacy College, Nanded
  • 2. Principle: • Sterilization: Is the process of making something free from bacteria or other living microorganisms. • Sterility Testing: Are done to detect if viable forms of micro-organisms are present or not on or in the pharmaceutical preparations.
  • 3. Which products undergo sterility tests? The test is applied to substances or preparations which, according to the Pharmacopoeia, are required to be sterile. For example ✦ Injections ✦ Implants ✦ Syringes ✦ Bandages ✦ Dressings ✦ Surgical Instruments ✦ Needles ✦ Injectables ✦ Bulk Solids ✦ Ophthalmic Products etc
  • 4. • If microorganisms are placed in a media that provides nutrients and water and kept at a favourable temperature the organism will grow and their growth can be indicated by turbidity in originally clear medium. • The sterility tests provide optimum conditions for the growth and multiplication of organisms, spores, etc. that might be a contaminant. • It is not possible to claim that a batch of products is sterile unless the entire content of each batch has been tested. • But these conditions are not possible because the article or the preparation under test is either made unstable (like a syringe) or is destroyed (like an injectable solution). • Thus only a part of the batch can be sampled for testing.
  • 5. MEMBRANE FILTRATION METHOD • Membrane has a nominal pore size not greater than 0.45 micron and diameter of approximately 50mm. • This method basically involves filtration of sample through membrane filters. • The filtration is assisted under Vacuum after filtration completion the membrane is cut into 2 halves and one halve is placed in two test tubes containing FTM, SCDM medium. • Incubate the media for not less than 14 days. Used for: ‣An oil or oily preparation. ‣Ointments that can be put into solutions. ‣Soluble powder. ‣Liquid products where volume in a container is 100ml or more. ‣Non bacteriostatic solid not readily soluble in culture media.
  • 6. Culture Media: For both AEROBES and ANAEROBES: Fluid Thioglycolate Media Alternate Fluid Thioglycolate Media For detection of AEROBIC and FUNGI: Soybean Caesin Digest Media, Sabourould’s Dextrose Agar Media
  • 7. DIRECT INOCULATION METHOD • It involves a direct inoculation of required volume of a sample in two test tubes containing a culture medium that is FTM, SCDM. • Volume of the preparation under examination is not more than 10% of the volume of the medium. • Incubate the inoculated media for not less than 14 days.
  • 9. Any DOUBT…??? (Disclaimer: The images and diagrams in this presentation have been downloaded from the google source. I am grateful to all the publishers & the google.)