Assessment of hydrogen peroxide fumigation method for disinfection and crosscontamination prevention for the production of measles and rubella live attenuated vaccines at POLYVAC

Abstract

The Center for Research and Production of Vaccines and Biologicals (POLYVAC) is currently producing measles and rubella live attenuated vaccines for the expanded immunization program and market. This study was conducted to evaluate the fumigation processes and cross - contamination prevention of measles and rubella viruses in the bulk production area. The Phileas 75-DEVEAs are used with 12ml of 7.4 % H2O2 per cubic meter (m3). The fumigation included spraying, nebulizing and exhausting for 1 hour 15 minutes, 2 hours 30 minutes, and 3 hours 30 minutes, respectively. The results showed the good environmental monitoring results met WHO criteria; complete killing BI consisting 103 of G. stearothermophilus; the ability to prevent measles and rubella virus cross-contamination met Japanese standards (reduced ≥ 3.0lg PFU). Based on this result, it is possible to establish fumigation procedures in other departments to ensure cleanroom quality at POLYVAC facility for measles and rubella vaccine production.