SX-6 Biological Indicator for Water-Bath Sterilization

The SX-6 Biological Indicator uses Geobacillus stearothermophilus (ATCC 7953) as its test organism, with a spore population of ≥1.0×10⁶ cfu per unit, and is designed for biological monitoring of 121℃ water-bath sterilization efficacy for aqueous injection products processed in moist-heat sterilizers. Indicators are placed at designated positions inside the sterilizer according to the sterilization process, then removed after the cycle, cooled to room temperature, and incubated directly at 56℃–60℃ for 48 hours without needing to open the ampoule; an unprocessed indicator is incubated in parallel as a positive control. Results are checked every 24 hours: a color change of the medium from purple to yellow indicates a positive result (sterilization failure), while the medium remaining purple after 48 hours indicates a negative result (satisfactory sterilization). The product complies with GB 18281-1, GB 18281-3, ISO 11138-1 and ISO 11138-3, and is covered by Zhejiang Disinfection License (2014) No.0006.