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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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Different <strong>Isolator</strong> Applications<br />

Requirements on Containment <strong>Isolator</strong>s<br />

• Generally operated under negative pressure to ensure max. operator safety<br />

• Typically classified as ISO 7 (Class 10,000 at rest, Grade C)<br />

• <strong>The</strong>y must not exchange air with the surrounding environment<br />

(except through a HEPA filter)<br />

• Equipped with nitrogen supply if required<br />

• All materials exiting the isolator must be cleaned or contained<br />

• <strong>The</strong>y must be cleanable in a reproducible and quantifiable manner;<br />

swab-tests and tracer substances should be used during qualification<br />

6

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