Biological Indicators and Culture Medium Vials

Delox Biological Indicators: The gold standard for spore-based validation of vaporized hydrogen peroxide bio-decontamination cycles. Based on calibrated populations of resistant spores, they provide quantitative and reproducible evidence of the antimicrobial efficacy achieved during each cycle.

Compliant with the most demanding international standards (ISO 11138, USP 1035), Delox Biological Indicators (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.

Technical Specifications

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 (room temperature)
Incubation time	7 days at 55±2°C
Culture medium	Tryptic Soy Broth (TSB) with pH indicator
Culture medium shelf life	36 months (room temperature)
Certification	ISO 11138-1, USP1035

Operational Workflow

Validation Protocol:

Pre-cycle: Strategic placement of BIs at critical locations within the enclosure.
During the cycle: Exposure of the BIs to the complete bio-decontamination cycle.
Post-cycle: Incubation at 55°C for 7 days in TSB growth medium.
Interpretation: A color change in the medium from purple to yellow indicates spore growth and, consequently, failure of the bio-decontamination cycle.
Controls: Positive and negative controls are included in every bio-decontamination cycle.

Placement Strategy:

Multiple points: Minimum of 3 locations, including the identified worst-case locations.
Critical locations: Areas considered most difficult for the hydrogen peroxide vapor to reach or decontaminate.

Biological Indicators and Culture Medium Vials

Technical Specifications

Operational Workflow

Validation Protocol:

Placement Strategy:

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