Risk Assessment Scoring for Challenge Surface Selection
| Risk Level | Description | Score |
|---|---|---|
| High | Surface characteristics: The surface has high surface roughness, susceptibility to surface degradation and/or water absorption, and presence of surface soil. | 3 |
| Prevalence: The surface covers an important proportion of the facility surfaces and/or is often represented in different production areas (e.g., bulk or finishing). | ||
| Operator interventions: During the process interventions, operators are in regular contact with the surface. | ||
| Medium | Surface characteristics: The surface properties do not facilitate microorganism development (low surface roughness, low level of degradation, low or no surface soil, etc.). | 2 |
| Prevalence: The surface covers a moderate proportion of the facility surfaces or is limited to a specific area (e.g., bulk or finishing). | ||
| Operator interventions: During the process interventions, operators are infrequently in contact with the surface. | ||
| Low | Surface characteristics: The surface properties prevent any microorganism development (bacteriostatic or bactericidal properties, very low roughness, very resistant and inert, typically clean surface prior to disinfection, etc.). | 1 |
| Prevalence: The surface covers a small surface and/or is represented in only a few production rooms. | ||
| Operator interventions: No process interventions with the surface. |