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