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Cycle Development and Validation

Cycle development is at the heart of any decontamination process and critical to its success.

When developing a decontamination cycle, it is important to determine all process parameters using chemical, physical and microbiological test procedures for reproducible, successful bio-decontamination. 

This is a statistical method to ideally adjust the decontamination process to the environmental conditions and the respective room situation. 

For Ortner Decon experts, these services are part of the daily routine.

 

 

Crucial to the Success of Any Decontamination Process

Process development and process validation is a technical challenge and requires a wide range of know-how and experience.

In the course of cycle development and validation, Ortner performs various additional services:

  • Temperature measurement
  • H2O2 concentration measurement
  • Humidity measurement

 

A Cycle Development is Divided Into 4 Phases

1. Preparation

To avoid condensation, the air in the room is pre- dried.

  • Remove moisture to a certain degree
  • Heat evaporator to SET temperature
  • Heating pipe capacity system
  • KPI = low relative humidity

2. Conditioning

The H2O2 solution is introduced into the room in an evaporated form.

  • Build up the H2O2 concentration near the dew point.
  • Condensation to be avoided at all points
  • KPI = highest H2O2 concentration within shortest time

3. Decontamination

The H2O2 concentration is maintained at a desired concentration level.

  • Determine the exposure time until LOG6 reduction is reached.
  • Maintain concentration without further increase
  • KPI = LOG6 decontamination at all sites

4. Ventilation

The H2O2 vapor is decomposed into water and oxygen in an environmentally friendly manner, leaving no residue.

  • Safe removal of H2O2
  • High turbulent air flow
  • KPI = threshold wet of ≤ 0.5 ppm

LOG6 Germ Reduction in Focus

In the case of H2O2 decontamination, a reduction of LOG6 is obtained during cycle development. 

By calculating the D value (decimal reduction time), it can then be extended to a theoretical reduction on LOG12.

 

 

Animal transfer hatch: Safe and reproducible decontamination processes are ensured by developed and reproducible cycles.
Mobile LC gas sensors for monitoring adjacent areas are connected to the ISU and all relevant parameters are logged via ISU.
LOG6 reduction of deployed bioindicators (Geobacillus stearothermophilus) at all deployed positions is considered evidence of successful decontamination.

Cycle Optimization

The success of a decontamination depends, among other things, on air humidity, H2O2 concentration, gas exposure time and temperature. Several measurement runs are performed to determine the cycle times.

Bio- Indicators | Chemical Indicators | Gas Concentration | Humidity | Temperature Processes

Cycle Validation

Cycle validation is performed after successful cycle development.

Three times decontamination based on bio-indicators optimally yield analogous results.

Certified biological indicators are used to validate the H2O2 decontamination process: They contain a magenta-colored indicator ink that reacts to hydrogen peroxide vapor.

 

Logging

Each completed decontamination cycle is logged on the ISU (Ortner H2O2 gas generator).

The decontamination log serves as proof of the successful completion of the decontamination process and contains all relevant cycle data.

In addition, audit trail files can be generated. These document every change in the parameters at the plant.

Knowledge advantage | Full-service partner | Expert status

The three decisive factors that make us the one-stop shop for all decontamination challenges.

We search and find an acceptable solution. Please contact us.

Focus on your Safety

The solution: Orter Technology & Know-how. Complete. Diverse. Pure.

 

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