Privatsphäre-Einstellungen

Kostenvergleich zwischen Reinraum und Isolator als Prüfumgebung für die Durchführung der Prüfung pharmazeutischer Muster auf Sterilität

Timo Krebsbach¹, Hans-Jürgen Bässler², Gernod Dittel³

¹ Labor L+S AG, Bad Bocklet
² SKAN AG, Basel
³ DITTEL Cleanroom-Engineering, Ried

Korrespondenz: Dr. Timo Krebsbach, Labor L+S AG; Mangelsfeld 4, 97708 Bad Bocklet (Germany), e-mail: Timo.Krebsbach@Labor-LS.de

Comparison of Costs between Cleanroom and Isolator as Environment for the Test for Sterility of Pharmaceutical Samples

The aim of the case study described in the following is to show the differences between the Test for Sterility of samples in the clean room compared to the Test for Sterility of test samples in an isolator. Labor L+S applies both systems simultaneously and is, therefore, able to benefit from years of experience. Investment costs as well as operating costs are shown. Conclusions can be made concerning the risk of contamination with microorganisms of both systems from which the safety of both processes can be indirectly concluded as far as the sterility is concerned.

Key words Isolator • Prüfung auf Sterilität, Kosten • Reinraum