A risk-based approach
Contamination control must distinguish cleaning, disinfection and process qualification. Surface conditions, production equipment, shadowed areas and airflow influence cycle design.
Technology selection
MO2ONE NANO/MICRO modules suit concepts requiring permanent integration and centralized control. Standalone MO2ONE devices offer another operating model. Select according to volume, access, quality requirements and available validation evidence.
Qualification records
Document starting conditions, zone preparation, cycle settings, critical points and microbiological results. Assess configuration changes to determine whether requalification is needed.
Qualify solutions for each site and permitted use.