its a method which tell us how we can evaluate vaccine by testing sterility

1. Evaluation of vaccines by
testing sterility
By: Ayesha Arshad

2. Vaccines

3. Definition
• Sterility is define as freedom from the presence
of viable microorganisms, is a strict ,
uncompromising, requirement of an injectable
dosage form.
• Sterility test is defined as :
Microbiological test applied to sterile product to
show are products manufactured and processed
under specification guided by cGMP.
Or to confirm the products either sterile or non.

4. Sterility Test
• Sterility of any killed/ inactivated or toxoid
vaccine is essential step in quality assurance and
certification of vaccine.
• It should be done using 20 vials from a
commercial batch of any vaccine.
• As per standards, one mL of well mixed vaccine
should be aseptically transferred to each of the
two media (Fluid thio-glycollate medium, FTM;
and Soybean casein digest medium, SCDM),
prepared in 100 ml volume.

5. • The inoculated FTM is incubated at 37°C while
SCDM is incubated at 25°C for 14 days and
observed for growth.
• If no growth appears then from each tube of
inoculated medium, one ml of contents is
transferred into tube containing 100 mL of
fresh and sterile respective medium and
incubated for 5 to 7 days as above.
• There should always be a positive and
negative control in the test.

6. • Growth of microbes should not be detected in
any of the tube inoculated with vaccine;
growth should always be visible in positive
control and no growth in negative control.
• The test takes 19 to 21 days to be completed.
• In case of any confusion test must be
repeated.
• The test was conducted under aseptic
conditions in designated sterility room.

7. • Unless otherwise stated all vaccines comply
with tests for sterility , except that for living
bacterial vaccines, growth of the organism
from which the vaccine was prepared is
permitted.