Biological indicator for dry heath pcs Argentina in pakistan

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Biological indicator for dry heath pcs Argentina in pakistan

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Category: Chemicals Tag: Biological indicator for dry heath pcs Argentina in pakistan

Description

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.