SXL-6 Self-Contained Biological Indicator for Liquid Sterilization

The SXL-6 is a self-contained biological indicator (BI) designed for monitoring moist-heat steam sterilization and water-bath sterilization of liquid pharmaceutical preparations at 108℃–118℃. Each unit consists of a Bacillus subtilis spore-impregnated carrier disc, a recovery culture medium sealed inside a glass ampoule, and a closed plastic housing, giving a spore concentration of ≥1.0×10⁶ cfu per unit. The isolated, self-contained design protects against external contamination while allowing the indicator to be immersed directly in the liquid product during the sterilization cycle, providing a faithful simulation of real sterilization conditions. After the cycle, the ampoule is activated and the unit is incubated at 35℃–39℃; a color change of the medium from green to yellow (or turbidity) after 48 hours indicates a positive (failed) sterilization result, while retained green color indicates a negative (successful) result. The product is manufactured under Patent No. ZL201520686977.3 and 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.