Biological Indicator (Self‑Contained)
Self‑contained biological indicator designed for steam sterilization monitoring (121–135 °C). Contains Geobacillus stearothermophilus spores with rapid readout up to 20 minutes. Includes spore carrier, culture medium ampoule, and process indicator label.
Specifications
| Feature | Specification |
|---|---|
| Brand / Model | Terragene Bionova®(Ultra Rapid Self‑Contained BI) |
| Process | Steam sterilization (vacuum-assisted and gravity air‑displacement) at 121–135 °C |
| Microorganism | Geobacillus stearothermophilus (ATCC® 7953) |
| Population | 1 × 10⁶ spores per vial |
| Read‑Out Time | 20 minutes (rapid fluorescence; optional visual pH color change at 48 h / 7 days) |
| D‑Values | At 121 °C: 1.5–4 min; at 132 °C: 0.15–0.7 min; at 134 °C: 0.1–0.6 min |
| Z‑Value | 8 – 30 °C |
| Color Indicator | Process label: pink → black; Medium: purple (sterile) → yellow (growth) |
| Mass & Dimensions | Approx. 2.3 – 2.4 g; Ø cap: 10.9 mm; Ø tube: 8.6 mm; Height: 57 mm |
| Shelf Life | 24 months from manufacture |
| Standards | ISO 11138‑1:2017, ISO 11138‑3:2017, ISO 11138‑8:2021, ISO 11140‑1:2014 |
| Packaging | Typically 50 per box |
| Applications | Healthcare, dental, pharmaceutical sterilization validation and routine monitoring |