Standardized spore-based validation for VHP cycle: Delox Biological Indicators (BIs) are the gold standard validation of hydrogen peroxide vapor decontamination cycles. These indicators are based on calibrated populations of resistant spores that provide quantitative and reproducible evidence of the antimicrobial efficacy achieved in each cycle.
Compliant with the most demanding international standards (ISO 11138, USP 1035), Delox BIs use Geobacillus stearothermophilus, an organism recognized as one of the most resistant to hydrogen peroxide, in a controlled population that ensures consistent challenge and reliable results.
These indicators are essential for initial equipment validation, periodic qualification, cycle failure investigation, and regulatory compliance in pharmaceutical, hospital, and research environments.
| Delox Biological Indicators | |
|---|---|
| Microorganism | Geobacillus stearothermophilus 12980 |
| Spore population | 2.5 x 10⁶ CFU/indicator |
| D-value | 1 minute at 700 ppm H₂O₂ |
| Carrier | Stainless steel metal disc wrapped in Tyvek® |
| Packaging | Individually sealed, package of 100 units |
| Shelf life | 12 months (4-8°C) |
| Incubation time | 7 days at 55±2°C |
| Culture medium | Tryptic Soy Broth (TSB) with pH indicator |
| Certification | ISO 11138-1, USP1035 |
