Erysipelothrix Rhusiopathiae Vaccine.

CFR · 2024-01-01 · US · Title 9

Erysipelothrix Rhusiopathiae Vaccine shall be prepared as a desiccated live culture of an avirulent or modified strain of (a) The Master Seed shall meet the applicable requirements prescribed in § 113.64 and the requirements in this section. (b) Each lot of Master Seed used for vaccine production shall be tested for immunogenicity. The selected bacterial count from the lot of Master Seed shall be established as follows: (1) Thirty (2) An arithmetic mean count of the colony forming units from vaccine produced from the highest passage of the Master Seed shall be established before the immunogenicity test is conducted. The 20 swine to be used as vaccinates shall be injected as recommended on the label with a predetermined quantity of vaccine bacteria. The 10 control swine shall be held separately from the vaccinates. To confirm the dosage calculation, an arithmetic mean count shall be established by conducting five replicate titrations on a sample of the bacterial vaccine dilution used. Only plates containing between 30 and 300 colonies shall be considered in a valid test. (3) The vaccinates and controls shall be examined and their average body temperature determined prior to challenge. Fourteen to twenty-one days postvaccination, the vaccinates and controls shall be challenged with a virulent (4) A satisfactory challenge shall be evidenced in the controls by a high body temperature or clinical signs including, but not limited to acute illness with hyperemia of the abdomen and e

official document · source cfr-2024 · id 9:§ 113.67