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Mikrobiologische Aspekte bei der Qualifizierung einer Fertigspritzenline mit E-Beam-Tunnel in Isolatorbauweise

Alexandra Stärk

Novartis Pharma AG, Stein (Schweiz)

Korrespondenz: Alexandra Stärk, Novartis Pharma AG, Schaffhauserstrasse, 4332 Stein (Schweiz), e-mail: alexandra.staerk@novartis.com

Microbiological Aspects of the Qualification of a Filling Line for Prefilled Syringes with E-Beam Tunnel in Isolator Design

The definition of the individual steps for a microbiological initial qualification of a filling line for prefilled syringes with isolator technology and E-beam tunnel for the decontamination of syringes in tubs requires a detailed knowledge of the respective systems and the processes.
The qualification procedure has to be agreed upon by production, quality assurance and microbiological quality control department, focusing in particular on the qualification of the E-beam tunnel and isolator. Here the main issues are decontamination efficacy, definition of an adequate environmental monitoring program and validation of the aseptic filling by media fills.
Furthermore it is recommended to perform preliminary “material studies” in order to guarantee the decontamination ability of all the materials in the isolator and the E-beam tunnel which are exposed to the H2O2 decontamination. Materials which are not or are hardly decontaminated with H2O2 should be removed from the system and should be replaced by suitable alternative materials.
To ensure the microbiological quality, single systems and processes have to be requalified/revalidated on a regular basis during routine production.

Key words E-Beam-Tunnel • Fertigspritzenlinie • Isolator • Media Fills • Mikrobiologische Qualifizierung • Umgebungsmonitoring