Hier finden Sie wissenschaftliche Publikationen aus den Fraunhofer-Instituten.

Plasma decontamination: A case study on kill efficacy of Geobacillus stearothermophilus spores on different carrier materials

: Semmler, E.; Novak, W.; Allinson, W.; Wallis, D.; Wood, N.; Awakowicz, P.; Wunderlich, J.


PDA Journal of pharmaceutical science and technology 70 (2016), No.3, pp.256-271
ISSN: 1948-2124
ISSN: 1079-7440
Journal Article
Fraunhofer IVV ()

A new technology to the pharmaceutical field is presented: surface decontamination by plasmas. The technology is comparable to established barrier systems like e-beam, volatile hydrogen peroxide, or radiation inactivation of microbiological contaminations. This plasma technology is part of a fully automated and validated syringe filling line at a major pharmaceutical company and is in production operation. Incoming pre-sterilized syringe containers ("tubs") are processed by plasma, solely on the outside, and passed into the aseptic filling isolator upon successful decontamination. The objective of this article is to present the operating principles and develop and establish a validation routine on the basis of standard commercial biological indicators. Their decontamination efficacies are determined and correlated to the actual inactivation efficacy on the pharmaceutical packaging material. The reference setup is explained in detail and a short presentation of the cycle development and the relevant plasma control parameters is given, with a special focus on the in-process monitor determining the cycle validity. Different microbial inactivation mechanisms are also discussed and evaluated for their contribution and interaction to enhance plasma decontamination. A material-dependent inactivation behavior was observed. In order to be able to correlate the tub surface inactivation of Geobacillus stearothermophilus endospores to metallic biological indicators, a comparative study was performed. Through consistently demonstrating the linear inactivation behavior between the different materials, it becomes possible to develop an effective and time-saving validation scheme.