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Monitoring of the Process Environment

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Containment Technology

Abstract

In aseptic operating production, the master plan for monitoring of the isolator provides meaningful information about the quality of the direct status of the aseptic manufacturing environment. Over a longer period of time, (trends) a consistent monitoring program allows to detect changes in the status “free of germs” of the isolator. The monitoring of the isolator helps to identify possible routes of contamination quickly and allows taking appropriate corrective action.

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References

  1. Mit Sicherheit steril. Sagasser Gero; CAV (Chemie Anlagen Verfahren) Fachartikel 2007 (http://www.cav.de)

  2. International Standard, ISO 14644–7: Clean rooms and associated controlled environments. Part 7. Separative devices (clean air hoods, glove boxes, isolators and mini environments) (2004)

    Google Scholar 

  3. ISO 10648-2: Containment enclosures Part 2: Classification according to leak tightness and associated checking methods

    Google Scholar 

  4. VDI 2083, Blatt 16: Reinraumtechnik, barrieresysteme (isolatoren, mini-environements, reinraummodule) wirksamkeit, zertifizierung. Verein Deutscher Ingenieure (VDI) (2010)

    Google Scholar 

  5. Sigwarth, V., Stark, A.: Effect of carrier materials on the resistance of spores of Bacillus stearothermophilus to gaseous hydrogen peroxide. PDA J. Pharm. Sci. Technol. 57(1), 3–11 (2003)

    CAS  Google Scholar 

  6. Schilder, G.: Freeze Dryer innovative design for handling potent drugs and/or packaging components with critical characteristics. ISPE Milan conferences, 11-2005, International Society for Pharmaceutical Engineering (ISPE) (2005)

    Google Scholar 

  7. Gessler A., Stärk A., Sigwarth, V., Moirandat, C.: How risky are pinholes in gloves? A rational appeal for the integrity of gloves. PDA J. Pharm. Sci. Technol. 65(3), (2011)

    Google Scholar 

  8. Krebsbach, T., Böttcher, F.: Leistungsqualifizierung von steriltest-isolatoren. Pharm. Ind. 74(3), 469–476 (2012)

    Google Scholar 

  9. Ergebnisse von Ringversuchen zur Validierung des Impaktionsverfahrens bei Schimmelpilzmessungen. VDB 67(10), 425–428 (2007)

    Google Scholar 

  10. Bjerner, G., Kene, V., Akerlund, E., Andersson, K.: Real-time microbiological air monitoring. Eur. J. Parente. Pharm. Sci. 17(2), 52–55 (2012)

    Google Scholar 

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Correspondence to Hans-Jürgen Bässler .

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Bässler, HJ., Lehmann, F. (2013). Monitoring of the Process Environment. In: Containment Technology. Springer, Berlin, Heidelberg. https://doi.org/10.1007/978-3-642-39292-4_9

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