1. Design Qualification – approved drawings, design specification documents, traceability matrix and quality plan

Compliance to European Directives –Machinery 2006/42/EC
Risk Assessments and Technical Files

2. FAT/SAT and IQ/OQ

Visualisation of airflow- smoke testing studies
Leak Tightness
Air velocity testing across the chamber
Functional and alarm testing
Filter Integrity
Sterilant Generator testing
Viable and Non-Viable – environmental monitoring equipment verification
Glove integrity testing

3. Cycle development

Cycle development establishes the conditions and parameters for an effective and reliable decontamination process. The decontamination process is validated with biological indicators (BI) with Geobacillus Stearothermophilus (10 6 spores) on a stainless-steel carrier

  • Load study/configuration
  • Temperature mapping
  • Smoke studies to identify worst case location in-terms of vapour distribution
  • Chemical Indicator studies, worse case locations determination
  • Biological Indicator Studies: Triplicate BIs at every worst-case location identified
  • Verification study to demonstrate 6 log reduction of the BI
  • Production cycle with added safety margin in parameters
  • Aeration studies to achieve <1ppm hydrogen peroxide

Photo Gallery

4. Cycle performance qualification

Cycle qualification provides documented evidence of the effectiveness and consistency of the developed decontamination cycle

  • Production cycle x 3
  • Aeration time qualification


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