SMEPAC (Standardized Measurement for Equipment Particulate Airborne Concentrations)

Outdated designation for the currently valid APCPPE guidance for assessing containment systems.

Note: Obsolete term

Relevance for existing documentation

Further information

01 Note: Obsolete term

SMEPAC is an outdated term and has been replaced by the current APCPPE guideline (Assessing the Particulate Containment Performance of Pharmaceutical Equipment). For current validations and regulatory submissions, only the ISPE APCPPE standard applies.

02 Relevance for existing documentation

In older approval documents and audit reports, the term SMEPAC is still used. When updating these documents, reference should be made to the current APCPPE standard.

03 Further information

The APCPPE guide was published in 2004 by ISPE (International Society for Pharmaceutical Engineering) and is continuously updated. It describes standardised test methods for measuring particle concentration in the breathing air during the operation of containment systems. See also: APCPPE.

All terms

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