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.

Request your individual scientific research study here:

Our research team is happy to assist you.

 

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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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Trace analyses in the isolator and loading for the localization of

  • Hydrogen peroxide and ozone in product packaging
  • Reference substances on material surfaces

Various methods and state-of-the-art equipment make possible trace analysis for hydrogen peroxide and ozone in product packaging, as well as for reference substances on material surfaces.

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Research Laboratory

Highly qualified experts work in a laboratory that is equipped with state-of-the-art equipment.

  • Impact of different materials on the decontamination process
  • Material outgassing for customer-specific materials
  • Compatibility test of materials with regard to H2O2 and other chemicals that are used in cleaning agents
  • Fluorescence testing to help verify the cleanability of components
  • Support in evaluating the cleaning processes that are used in the isolator

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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

 

Information sheets:

ACTIVE H2O2 Trace Analysis

PERSISTS Material Tests

CFD Simulation

CLEAN Mapping

CLEAN Check Isolator Air

ACTIVE Ozone Challenge Test

ACTIVE Sterility Testing 

CLEAN Check Material 

 

Request your individual scientific research study here:

Our research team is happy to assist you.

 

[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).

 

 

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