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References

  • Dunkelberg H, Wedekind S. A new method for testing the effectiveness of the microbial barrier properties of packaging materials for sterile products. Biomed Tech (Berl) 2002;47:278-284 
  • Dunkelberg H, Wedekind S. Preliminary results for a new final package test to assess the quality of sterile package systems. Infect Control Hosp Epidemiol 2004; 25: 26-29 
  • Dunkelberg H, Rohmann S. Test to determine sterile integrity of wrapped medical products at a probability of recontamination of 1:1,000,000. Infect Control Hosp Epidemiol 2006; 27: 367-371 
  • Dunkelberg H, Fleitmann-Glende F. Measurement of the microbial barrier effectiveness of sterilization containers in terms of the log reduction value for prevention of nosocomial infections. Am J Infect Control 2006;34:285-9 
  • Dunkelberg H., Schmelz U. Determination of the efficacy of sterile barrier systems against microbial challenges during transport and storage. Infect Control Hosp Epidemiol 2009;30:179-183
  • Dunkelberg H. On-site application of the exposure chamber method in hospitals to control the airborne microbial recontamination of sterilzed products during shelf life. Intern J Medical Microbiol 2012;302S1:29
  • Dunkelberg H. Sterile supply of medical devices and pharmaceutical products - quality standards and applied risk management. Pharm Ind 2016;78:1644-1648
  • Dunkelberg H. Maintenance of Sterility: Base of Aseptic Procedures. Dtsch Arztebl Int 2016;113:737). 
  • Dunkelberg H. Data-based assessment of the maintenance of sterility. Dtsch Arztebl Int 2017; 114(43): 737; DOI: 10.3238/arztebl.2017.0737b
  • Dunkelberg H. Monitoring sterile pacemaker implants. Dtsch Arztebl Int 2018; 115(42): 712; DOI: 10.3238/arztebl.2018.0712a
  • Dunkelberg H. Long-term monitoring of airborne microbial challenge and use of cold atmospheric air plasma technology - basis for a data-based sterile storage management according to the sterility assurance level of 1:1,000,000. Pharm Ind 2019;81:1130-1136
  • Dunkelberg H. Calculation of the expected shelf life in sterile supply by web-based analysis of long-term exposure data. Pharm Ind 2022;84:790-793
  • Dunkelberg H. Calculation of the anticipated shelf life in sterile supply by web-based analysis of long-term exposure data. 74th Annual Meeting of the German Society for Hygiene and Microbiology e.V. (DGHM) 5-7 September 2022,  Abstracts . www.dghm-kongress.de.

Lectures and presentations 2015-2022

  • Dunkelberg H. Requirements of validation of packaging systems and sterility assurance. 16th World Sterililization Congress & Annual Conference of AFS, 7-10 October 2015 Lille, France
  • Dunkelberg H. Quality standards and applied risk management in sterile supply of medical devices and pharmaceutical products. 1st European Lab Technology Forum 2015, November 5-6, 2015, Sartorius College, Goettingen, Germany
  • Dunkelberg H. Assessment of compatibility of microbial barrier properties of packaging material of terminally sterilized products with the airborne microbial challange during the storage period (Abstract). VAAM Annual Meeting 2017, 69th Annual Meeting of the DGHM, 5-8 March 2017, Wuerzburg, Germany
  • Dunkelberg H. Evidence based sterile storage. 10th International Sterilization Disinfection Congress, 29 November - 3 December 2017, Antalya, Turkey
  • Dunkelberg H. Proposal for controlling the maintenance of sterility at the highest possible sterility assurance level up to the point of use. 18th World Sterilization Congress, Bonn, 4-7 October, 2017
  • Dunkelberg H. Use of cold atmospheric air plasma sterilization and continuous monitoring of the airborne microbial challenge for in-process control of maintenance of sterility of terminally sterilized products.  70th Annual Meeting of the German Society for Hygiene and Microbiology (DGHM), 19 - 21 February 2018 • Ruhr University Bochum.
  • Dunkelberg H. Using of Web-based analysis of atmospheric air pressure monitoring in storage areas for shelf life calculation of terminally sterilized items. 71st Annual Meeting of the German Society for Hygiene and Microbiology (DGHM), 25 - 27 February 2019 • Georg-August-University Goettingen.
  • Dunkelberg H. Calculation of the anticipated shelf life in sterile supply by web-based analysis of long-term exposure data. 74th Annual Meeting of the German Society for Hygiene and Microbiology (DGHM), 5-7 September 2022, Berlin