Vaccine must not be released until the successful completion of the sterility test. In case of extreme urgency, vaccine may be released prematurely if the veterinary authorities accept responsibility in writing.

PROCEDURE

1. Check 1st and 2nd cultures for turbidity each working day to 18th day.

2. If turbidity > controls then examine microscopically after Gram staining.

3. If no turbidity or organisms seen, vaccine PASSES.

4. If organisms seen, REPEAT test with same number of fresh samples.

5. If same organism seen on repeat test, vaccine FAILS.

6. If different organism seen on repeat test, REPEAT test with twice number of orginal samples.

7. If no growth, vaccine PASSES. If any growth, vaccine FAILS.

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