Sterility assurance
Sterility assurance means more than successful decontamination. Your processes must remain effective, traceable, and fully compliant over time. SKAN supports you with scientifically based services—from cycle development and microbiological requalification to material testing and H₂O₂ analysis. This helps you identify risks early, generate reliable data, and ensure stable aseptic processes in the long term.
- Digital
CFD simulations
Ensure isolator design compliance with airflow simulations
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- On-site
SMEPAC Isolator Containment Test
Validation of isolator containment performance in accordance with ISPE®
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- On-site
- At SKAN
Material compatibility tests
Evaluation of material suitability for aseptic environments
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- On-site
- At SKAN
Cleaning strategy
Science-based cleaning strategy from the expert
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- On-site
Microbiological (re-)qualification
Reliable proof of permanently effective decontamination cycles
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- At SKAN
- On-site
H₂O₂ residue check
Identify risks posed by H₂O₂ residues early
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- On-site
- At SKAN
Dosimetry
Reliable dose verification and residual gas analysis for your ebeam system
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- On-site
Cycle transfer and performance test
Safely transfer and validate proven cycles to new isolators
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- On-site
Cycle development
Your key to validated decontamination processes
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