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Sterility Testing
Sterility Testing

          : Sterility Testing is defined as a
test performed in pharmaceutical lab to
assess whether the manufactured product
is     free         from       contaminating
microorganisms or not.
Principle of Sterility Testing

Sterility Testing only shows that organisms
capable of growing in selected conditions
are absent from the fraction of batch that
has been tested.
What is a Batch?

Batch is a homogeneous collection of
sealed containers prepared in such a
manner that the dangers of contamination
is the same for each of the units present
in it.
Benefits of Sterility Testing

•Helps     to   detect    the presence   of
microorganisms in a sample
• Ensures that the manufactured product has
low risk of contamination
Steps for Sterility Testing

1. Sampling
2. Medium     used     for
   testing
3. Method of testing
4. Observation
5. Drawing
   conclusions
Methods of Sterility Testing

Method 1:   Membrane Filtration
Method 2:   Direct Inoculation method
Membrane Filtration


    Suitable   for   samples   with   large
volumes
Direct Inoculation

     Suitable for samples with small
volumes
Precautions

Sterility Testing must be always carried
out under aseptic condition
Thank You


Presented by Eric Ittah

Email : eric@ericittah.ca

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Eric Ittah PPT | Eric Ittah Sterility Testing PPT

  • 2. Sterility Testing : Sterility Testing is defined as a test performed in pharmaceutical lab to assess whether the manufactured product is free from contaminating microorganisms or not.
  • 3. Principle of Sterility Testing Sterility Testing only shows that organisms capable of growing in selected conditions are absent from the fraction of batch that has been tested.
  • 4. What is a Batch? Batch is a homogeneous collection of sealed containers prepared in such a manner that the dangers of contamination is the same for each of the units present in it.
  • 5. Benefits of Sterility Testing •Helps to detect the presence of microorganisms in a sample • Ensures that the manufactured product has low risk of contamination
  • 6. Steps for Sterility Testing 1. Sampling 2. Medium used for testing 3. Method of testing 4. Observation 5. Drawing conclusions
  • 7. Methods of Sterility Testing Method 1: Membrane Filtration Method 2: Direct Inoculation method
  • 8. Membrane Filtration Suitable for samples with large volumes
  • 9. Direct Inoculation Suitable for samples with small volumes
  • 10. Precautions Sterility Testing must be always carried out under aseptic condition
  • 11. Thank You Presented by Eric Ittah Email : eric@ericittah.ca