abstract |
This invention relates to a biological indicator, comprising: a carrier; and a spore deposit on the carrier, wherein from about 70% to about 95% of the area of the spore deposit comprises spores residing in a single spore layer, and the remainder of the area of the spore deposit comprises spores residing in a stacked configuration. Preferably, the indicator is a self-contained biological indicator (SCBI). Preferably, the spores are of the Bacillus or Clostridia genera, more preferably Geobacillus stearothermophilus spores. Also described are a sterilization process, a process for determining the effectiveness of a sterilization process and a process for making a biological indicator. |