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Can't Touch This! The Three W's of Barrier Isolator Technology

Can't Touch This! The Three W's of Barrier Isolator Technology

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VHP Sterilization<br />

Process Parameters<br />

Temperature • Determination <strong>of</strong> temperature differences in the <strong>Isolator</strong><br />

• Reproducibility <strong>of</strong> temperature pr<strong>of</strong>iles<br />

Relative Humidity • Development <strong>of</strong> conditioning phase:<br />

Determination <strong>of</strong> time to reach max. relative humidity<br />

• Reproducibility <strong>of</strong> RH-pr<strong>of</strong>ile<br />

VHP-Concentration • Development <strong>of</strong> conditioning phase:<br />

Determination <strong>of</strong> time to reach max. VHP concentration<br />

• Reproducible run <strong>of</strong> concentration curve<br />

• Definition <strong>of</strong> “worst case” environmental conditions:<br />

low gas concentration at low temperatures in the isolator<br />

VHP-Distribution • Uniform distribution <strong>of</strong> VHP with chemical indicators<br />

VHP-Flow • Unidirectional/turbulent VHP Flow, airflow pattern<br />

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