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Dekontaminationsprozesse und -systeme bei der Abfüllung genesteter Fertigspritzen

Isolatorsysteme und Elektronenstrahl-Tunnels

Volker Sigwarth, Frank Lehmann und André Bösiger

Skan AG, Basel (Schweiz)

Korrespondenz: Volker Sigwarth, Skan AG, Binningerstrasse 116, 4123 Allschwil (Schweiz), e-mail: Volker.Sigwarth@skan.ch

Decontamination Processes and Systems for the Filling of Nested Pre-sterilized Syringes / Isolator technology and electron beam tunnels

Today isolator technology is well established and accepted in the pharmaceutical industry and production. Particularly filling of pre-sterilized syringes is nowadays advantageously done in a combination of isolator technology and electron beam tunnels; this is one reason why such systems are more and more used for this purpose. The use of isolator technology demands special requirements regarding surface decontamination. In general the decontamination of the inner surfaces of an isolator chamber is done using vaporized hydrogen peroxide (H2O2). For decontaminating the outer surface of the syringe tubs electron beam tunnels are increasingly used.
The following article introduces the surface decontamination processes involved in an isolator system designed for filling pre-sterilized syringes. Focusing on the surface decontamination using vaporized H2O2 for isolators and electron beams for syringe tubs first the process mechanisms and inactivation parameters are described. Based on the actual requirements, guidelines and standards concerning surface decontamination of isolator systems approaches for the physical and microbiological qualification are presented and hints for practical proceedings are made. Finally the current applications, possible alternatives and future challenges of these two decontamination processes are discussed.

Key words Biologische Indikatoren • Dekontamination, H2O2 • Elektronenstrahlen-Sterilisation • Fertigspritzen • Isolatortechnologie