Mit dem Dampf-Luft-Gemisch-Verfahren (DLGV)
Originale
Abstract
Sterilization of liquid products in their final containers by use of the steam air mixture process (DLGV)
Sterilization is an important quality-inducing process step in manufacturing of pharmaceutical products. Especially for products that are sterilized in the final container, sterilization is the decisive process step for achieving the most important quality attribute in addition to effectiveness – sterility. In the case of liquid products, which are already packaged in their final container, sterilization is often carried out using the steam air mixture process (DLGV). The robustness of this method requires knowledge in process engineering, especially when the heat input into the product requires a certain homogeneity. In order to guarantee the required process and product safety, various process parameters must be observed. This article describes the most important of these requirements:
approved sterilization methods
various sterilization processes using steam
description of the processes regarding their advantages and disadvantages
process selection for different loads
use of lethality calculation as a measure of heat input
approach to a required homogeneous heat input into the product
Korrespondenz:
Jörn Möller, Testo Industrial Services GmbH, Gewerbestr. 3, 79199 Kirchzarten (Germany); e-mail: jmoeller@testotis.de
Zusammenfassung
Es werden die wichtigsten verfahrenstechnischen Anforderungen beschrieben, die im Vorfeld der Implementierung des Dampf-Luft-Gemisch-Verfahrens (DLGV) zur Sterilisation eines flüssigen Produkts in seinem Endbehältnis im pharmazeutischen Umfeld betrachtet werden sollten. Diese sind im Einzelnen:
Zugelassene Sterilisationsmethoden
verschiedene Sterilisationsverfahren mittels Wasserdampfs
Beschreibung der Verfahren mit ihren Vor- und Nachteilen
Verfahrensauswahl bei