Cycle Development

 

Cycle development is a statistical method to define the amount of vaporised hydrogen peroxide and the duration of the decontamination process required for process success.

Range of services

  • „„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 optimization

 

With a qualified workforce and substantial experience in isolator designs, SKAN is also able to offer cycle development for third party barrier isolators with external decontamination systems. 

Limited Spearman-Karber Method first applied by SKAN, recommended by the FDA [1]

 

[1] Sigwarth V., Moirandat C., Development and Quantification of H2O2 Decontamination Cycles. PDA Journal of Pharmaceutical Science and Technology. Vol. 54, No. 4, July/August 2000. pp. 286–304.

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