BIOLOGICAL TESTS FOR LIVING CONTAMINANTS IN VACCINES

1. BIOLOGICAL TESTS FOR
LIVING CONTAMINANTS IN
VACINES
BY
SSB.SAIKANTH
PHARMACEUTICAL
ANALYSIS AND QUALITY
CONTROL (MP616 8005)

3. VARIOUS TYPES OF
CONTAMINANTS
• (1) AEROBIC CONTAMINANTS
• (2)SALMONELLA SPECIES
• (3)CONTAMINATION WITH FUNGI

4. TESTING FOR AEROBIC
CONTAMINANTS
• 1. Inoculate 1 mL of the wet vaccine
or reconstituted freeze dried
vaccine into 9 mL of broth.
• 2. Incubate at 30°C to 37°C for 24
hours.
• 3. Record results Interpretation
Gross contamination after 24 hours,
retest in twice the number of
cultures. If contamination is evident
after the second culture, discard
the vaccine

5. TESTING FOR SALMONELLA
SPECIES
• 1. Inoculate 9 mL of one of the liquid
media with 1 mL of vaccine
• 2. Incubate at 37°C for 18 to 24
hours
• 3. Inoculate a loopful of incubated
broth onto one of the solid media.
• 4. Incubate 18 to 24 hours. Observe .
If no Salmonella growth is detected,
incubate again for 18 to 24 hours. 5.
Discard the vaccine, if Salmonella
are detected.
•

6. TEST FOR CONTAMINATION
WITH FUNGI
• Testing for contamination with fungi
Sabouraud dextrose agar is used to
cultivate fungi. Chloramphenicol at 0.05
g/L can be added to inhibit bacteria.
• Inoculate the agar with 100 mL of vaccine
and spread over the plate. Inoculate a
control plate with diluent only. Incubate
at 25°C to 30°C for one week.
• Observe daily and record results. Growth
on the control plate invalidates the test,
which should then be repeated. Vaccine
should be free of fungal contamination.

7. THANK YOU