Biological Indicator for Steam Sterilization 121-134 °C, Geobacillus stearothermophilus spores 10⁶, 24 h read-out, 51 mm vial, 50 vials

The biological indicator is designed for monitoring and validating the efficiency of steam sterilization processes performed in autoclaves at temperatures between 121 °C and 134 °C. It enables visual interpretation of sterilization results within 24 hours, ensuring standardized control of both vacuum-assisted and gravity displacement cycles. Each vial contains a paper carrier inoculated with viable spores of Geobacillus stearothermophilus (≥ 10⁶ spores), enclosed in a thermoplastic tube together with a sealed glass ampoule containing a pH-sensitive culture medium initially purple in color. After incubation at 58-60 °C ± 2 °C for 24 hours, a color change from purple to yellow indicates a failed sterilization process, while no color change confirms an effective sterilization cycle. Technical characteristics: • 24-hour visual read-out time. • Self-contained biological indicator for steam sterilization control. • Culture medium: 0.5 - 0.7 mL, purple color. • Tube dimensions: 51 mm height × 8.3 mm outer diameter × 0.6 mm wall thickness. • Glass ampoule: 43 mm height × 6 mm outer diameter × 0.5 mm wall thickness. • Polypropylene cap: 14 mm height × 10.4 mm outer diameter × 0.8 mm wall thickness. • Cap filter: medical-grade paper, 9 mm diameter. • D-values: D₁₂₁ = 1.5 - 3 min, D₁₃₄ = 0.2 - 0.4 min. • Test microorganism: Geobacillus stearothermophilus (≥ 10⁶ spores). • Single-use indicator. Storage and transport conditions: Store the vials at room temperature (15 °C - 30 °C) with relative humidity between 30 % and 80 %. Transport the product in sealed, reinforced boxes to prevent breakage or contamination. Avoid storing near sterilizing agents such as ethylene oxide, dry heat, or radiation sources. General instructions for use: 1. Label the test vial with sterilizer and load identification details. 2. Place the biological indicator inside an appropriate process challenge device (PCD) and position it in the most difficult location for steam penetration. 3. Run the sterilization cycle according to the autoclave manufacturer’s instructions. 4. After the cycle, allow 10 minutes for cooling and depressurization. 5. Verify the chemical process indicator on the vial label for exposure confirmation. 6. Activate the biological indicator by crushing the internal glass ampoule to release the culture medium onto the spore carrier. 7. Incubate the test and control vials at 58 - 60 °C ± 2 °C for 24 hours. 8. A valid test requires a positive result (yellow color) from the control vial and no color change (purple) from the processed vial. This biological indicator provides a reliable, standardized method for monitoring steam sterilization efficiency in medical, dental, and laboratory environments, ensuring accurate performance assessment of autoclave cycles.