| Feature | Typical Specification |
| Intended Use | Monitoring the efficacy of dry heat sterilization processes (e.g., hot air ovens) in healthcare, industrial, and laboratory settings. |
| Sterilization Process | Dry Heat / Hot Air |
| Temperature Range | Typically used for cycles between $150^\circ \text{C}$ to $180^\circ \text{C}$ (Argentine norms often cite $160^\circ \text{C}$ to $170^\circ \text{C}$). |
| Test Organism | Bacillus atrophaeus (formerly Bacillus subtilis var. niger) spores. |
| ATCC Strain | ATCC $\text{9372}$ (A recognized culture collection strain). |
| Spore Population | Not less than $10^5$ or $10^6$ spores per carrier. |
| D-Value ($\text{D}_{160^\circ \text{C}}$) | $\ge 1.0$ minute (The time required to kill $90\%$ of the spore population at $\mathbf{160^\circ \text{C}}$). |
| Z-Value | $\ge 20^\circ \text{C}$. |
| Format | Typically a Spore Strip (paper carrier) or a Semi-Self-Contained system (separate culture medium/vial). |
| Incubation Temp. | $37^\circ \text{C} \pm 2^\circ \text{C}$ (The optimal growth temperature for B. atrophaeus). |
| Readout Time | Conventional result after $\mathbf{48}$ hours (visual color change). |
| Result Indication | Positive (Failure): Culture medium changes color (e.g., Blue to Yellow) indicating spore growth. Negative (Success): Medium remains the original color (e.g., Blue/Purple). |
| Chemical Indicator | Built-in Process Indicator (Type 1) on the label/packaging that changes color (e.g., to Brown) upon exposure to dry heat. |
| Regulatory Compliance | Complies with ISO 11138-1 and ISO 11138-4 (Sterilization of health care products – Biological indicators – Part 4: Dry heat sterilization) and local standard IRAM 37102-1. |
| Local Approval | Authorized by ANMAT (Administración Nacional de Medicamentos, Alimentos y Tecnología Médica) in Argentina. |
Biological indicator for dry heath pcs Argentina in pakistan
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