Competence Center

The development of the integrated hydrogen peroxide H2O2 decontamination system has made SKAN the world market leader in the special field of pharmaceutical isolators for product and personnel protection. Therefore SKAN is not just a manufacturer of barrier isolators – the entire decontamination process is also a major task. In close cooperation with stakeholders in the pharmaceutical industry and universities, the Competence Center of SKAN continuously improves knowledge [1] and expertise. Experienced specialists in the Competence Center are completely dedicated to processing validation microbiology, applied science, and research and development. For this reason, all innovative products are fully GMP-compliant in order to meet the challenging requirements of clients in the pharmaceutical industry. To reach this goal, the interdisciplinary team of the SKAN Competence Center puts all its efforts into: „„cycle development methods, H2O2 decontamination process and analysis „„of product development.

 

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Cycle Development of H2O2 Processes

  • „„D-value estimation and D-value determination
  • Worst case studies
  • „„Determination of aeration time to optimise the decontamination cycle
  • „„Temperature and humidity mappings and chemical indicator mappings
  • „„Customer specific cycle optimisation

 

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Low level H2O2 Concentration Analysis

With different methods and the latest technical equipment the H2O2 concentration in the atmosphere and/or the product can be quantified (measurement in %, ppm and ppb). [2]

 

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Laboratory Research and Services

Highly qualified experts work in the laboratory, equipped with the latest lab equipment.

  • „„Validation of third-party biological indicators
  • „„Effect of different materials on the decontamination process [3]
  • „„Material outgassing for customer specific load or construction material
  • „„Compatibility tests of material regarding vaporised H2O2
  • „„Design of catalytic converters for H2O2 processes

 

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Development of Decontamination Processes

Different types of decontamination technologies are used in the pharmaceutical industry. The SKAN Competence Center develops and optimises decontamination processes:

  • „„Vaporisation of H2O2
  • „„Catalytic converters
  • „„Micro-nebulization of H2O2 (SKANFOG®)
  • Electron beams (E-Beam)

 

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Innovative Product Development

The main goal of the R&D department is the invention and engineering of products close to market needs and highest customer requirements. [4]

  • „„Integrated H2O2 vaporisers for different applications (isolators, rooms, airlocks)
  • „„Mobile decontamination devices (SKANFOG®)
  • „„Custom-designed catalytic converters
  • WirelessGT for standardised and fast glove testing
  • Contract research projects with state-of-the-art equipment
  • Decontamination process developments

 

[1] Sigwarth V., Huber T., Trends and Advances in Isolator Technology. Pharm Eng. March/April 2011; 31(2).
[2] Analysis of H2O2 Low Concentrations, Methods and Results Dr. sc. nat. Daniel Eichenberger Presentation in Washington D.C., October 2009
[3] Sigwarth V., Stärk A., Effect of Carrier Materials on the Resistance of Spores of Bacillus stearothermophilus to Gaseous Hydrogen Peroxide. PDA Journal of Pharmaceutical Science and Technology. Vol. 57, No. 1, January/February 2003. pp. 286–304.
[4] Sigwarth V, Huber T. Trends bei der Entwicklung von Isolatoren für die pharmazeutische Industrie. Pharm. Ind. 71, Nr. 2, 234-344 (2009).