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What general steps should a facility include in SOPs to take when pressures and/or air changes per hour (ACPH) drop out of range?

Jun 22, 2022

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USP and NAPRA Model Standards do not address how to handle these excursions. Have

procedures in place for how to handle this situation. If these parameters are not able to

be maintained, then the facility is not considered a compliant cleanroom and should be

considered a segregated compounding area until an investigation can be performed,

and the problem is resolved.

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