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SMEPAC (Standardized Measurement for Equipment Particulate Airborne Concentrations)
Veraltete Bezeichnung für den heute gültigen APCPPE-Leitfaden zur Bewertung von Containment-Systemen.
Inhaltsverzeichnis
01
Hinweis: Veraltete Bezeichnung
02
Relevanz für bestehende Dokumentationen
03
Weiterführende Information
01
Hinweis: Veraltete Bezeichnung
SMEPAC ist eine veraltete Bezeichnung und wurde durch den aktuellen APCPPE-Leitfaden (Assessing the Particulate Containment Performance of Pharmaceutical Equipment) abgelöst. Für aktuelle Validierungen und regulatorische Einreichungen gilt ausschließlich der APCPPE-Standard der ISPE.
02
Relevanz für bestehende Dokumentationen
In älteren Zulassungsunterlagen und Auditberichten wird noch der Begriff SMEPAC verwendet. Bei der Aktualisierung dieser Dokumente sollte auf den aktuellen APCPPE-Standard verwiesen werden.
03
Weiterführende Information
Der APCPPE-Leitfaden wurde 2004 von der ISPE (International Society for Pharmaceutical Engineering) veröffentlicht und wird kontinuierlich aktualisiert. Er beschreibt standardisierte Testmethoden zur Messung der Partikelkonzentration in der Atemluft beim Betrieb von Containment-Systemen. Siehe auch: APCPPE.
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