Biological Indicator for Autoclave Sterilization Control 121-134 °C, Geobacillus stearothermophilus Spores 10⁶, 24 h Readout, 51 mm Vial, 50 Vials

Product details

Biological indicator for controlling and monitoring the efficacy of steam sterilization processes in autoclaves, in the 121–134 °C temperature range. The product contains viable Geobacillus stearothermophilus spores and allows accurate verification of vacuum-assisted or gravity-displacement sterilization cycles, with a visual readout of the result after 24 hours. Intended for use in medical and industrial settings.

Technical Specifications

• Test microorganism: Geobacillus stearothermophilus (≥ 10⁶ spores)
• Temperature range: 121–134 °C
• D-values: D₁₂₁ = 1.5–3 min; D₁₃₄ = 0.2–0.4 min
• Visual readout: 24 hours
• Culture medium: 0.5–0.7 mL, initially purple
• Incubation: 58–60 °C ± 2 °C
• Chemical indicator: included on the label
• Single-use product

Dimensions and Components

• Vial: height 51 mm, outer diameter 8.3 mm, wall thickness 0.6 mm
• Internal glass ampoule: height 43 mm, outer diameter 6 mm, wall thickness 0.5 mm
• Polypropylene cap: height 14 mm, outer diameter 10.4 mm, wall thickness 0.8 mm
• Cap filter: medical-grade paper, diameter 9 mm
• Spore carrier: paper disc in a thermoplastic tube

Directions for Use

1. Fill in the vial label with the sterilizer, load and processing details.
2. Place the indicator in a suitable process challenge device (PCD) and position it in the area of the load that is hardest for steam to reach.
3. Run the complete sterilization cycle according to the autoclave manufacturer's instructions.
4. After the cycle is complete, wait 10 minutes for cooling and depressurization.
5. Check the change of the chemical indicator printed on the vial label.
6. Activate the biological indicator by crushing the internal glass ampoule so that the culture medium fully covers the spore carrier.
7. Incubate the vial at 58–60 °C ± 2 °C for 24 hours.
8. A change in the medium color from purple to yellow indicates that the sterilization process did not reach the required parameters. If the medium remains purple, the efficacy of the cycle is confirmed. Results are valid only if the control vial (positive control) turns yellow.

Package Contents

• 50 biological indicator vials
• Quantity per case: 9 packs

Storage and Transport Conditions

• Temperature: 15–30 °C
• Relative humidity: 30–80%
• Transport in closed, reinforced packaging to prevent damage to internal components
• Do not store near sterilization sources: ethylene oxide, radiation, dry heat or other similar processes