An assessment of microbiological methods to test sterility of foot-and-mouth disease vaccines produced in Brazil

Rodenbusch, Carla RosaneSilveira, Luiz Roberto daBavaresco, Álvaro RicardoSfoggia, Marcus Vinícius Burgel

Background: Foot-and-mouth vaccines are an important tool in the control and eradication of the disease. In order to be commercialized, vaccines produced in Brazil undergo an evaluation process by health authorities, which includes sterility testing, residual active virus, potency, thermal stability, volume and non-structural protein activity. Sterility tests described in the Brazilian Pharmacopeia and by the World Organization for Animal Health (OIE) include direct inoculation and membrane filtration methods. The objective of the present study was to evaluate these two methods used to analyze sterility of vaccines against foot-and-mouth disease produced in Brazil. Materials, Methods & Results: Vaccines produced by the six main laboratories in Brazil were initially tested for filtration capacity. The sensitivity of the two techniques was determined artificially contaminating vaccines using known bacterial concentrations. Vaccines (9 bottles) from the same manufacturer were inoculated with 5 mL of steady-state growths of Pseudomonas aeruginosa, Candida albicans, and Clostridium sporogenes to final concentrations of 0.1, 1 and 10 CFU/ mL and a final volume of 55 mL. Bottles were manually shaken for 1 min to complete homogenization of contents. Then, 10 mL of each flask were used in assessment of the direct inoculation method, and 10 mL were used to evaluate the membrane [...](AU)

1. Direct inoculation
2. Sterility
3. Membrane filtration
4. Foot-and-mouth disease
5. Vaccine