An Example of Relative Risk Evaluation Worksheet
| ID #: FILTER FAMILY 1 | |||
|---|---|---|---|
| Material Name: PVDF Filter | |||
| Raw Material Specification Number: 0145 | |||
| Risk Variables | Qualifier | Risk Values | Risk of Material in Question |
| Chemical Compatibility | |||
| Good | 101 | ||
| Very Good | 5 | 1 | |
| Excellent | 1 | ||
| Proximity to BDS | |||
| Final Formulation | 10 | ||
| Purification | 6 | 2 | |
| Fermentation | 2 | ||
| Extraction Capability of Solvent | |||
| High | organic | 10 | |
| Medium | aqueous/organic mixture2 | Ratio | 4 |
| Low | water | 4 | |
| Length of Contact | |||
| High | > 30 days | 10 | |
| Medium | > 24 h to 30 days | 6 | 6 |
| Low | < 24 h | 2 | |
| Product-Contact Surface Area | |||
| High | > 50 sq. ft. | 10 | |
| Medium | 5 to 50 sq. ft | 6 | 2 |
| Low | < 5 sq. ft | 2 | |
| USP Class VI Testing | |||
| Unknown/Fail | 10 | 0 | |
| Pass | 0 | ||
| Temperature | |||
| High | >70 °C | 10 | |
| Medium | 37 to 70 °C | 6 | 2 |
| Low | 2 to 37 °C | 2 | |
| Inherent Material Resistance to Extraction | |||
| High | Elastomers/plasticized polymers | 10 | |
| Medium | Rigid plastic and Type II and III glass | 4 | 10 |
| Low | Metals and Type I glass | 1 | |
| Relative Risk Factor (Sum) | 27 | ||