Служба валидации компонентов
| Верификация и валидация | Одноразовые
мешки |
Силиконовые
трубки |
Фитинги | Асептические
коннекторы |
|---|---|---|---|---|
| Film Specifications | ✓ | — | — | — |
| Connection Strength | ✓ | — | — | — |
| Drop Test | ✓ | — | — | — |
| Heat Seal Strength | ✓ | — | — | — |
| Freezing Test | ✓ | — | — | — |
| Chemical Compatibility | ✓ | ✓ | ✓ | ✓ |
| Extractables | ✓ | ✓ | ✓ | ✓ |
| TOC, Conductivity and pH | ✓ | ✓ | — | — |
| Particulate Matter | ✓ | ✓ | — | ✓ |
| Bacterial Endotoxins Test | ✓ | ✓ | ✓ | ✓ |
| Sterility Testing | ✓ | — | — | — |
| Biological Reactivity Test | ✓ | ✓ | ✓ | ✓ |
| FDA 21 CFR Indirect Food Additive | ✓ | ✓ | ✓ | — |
| Burst Strength | — | ✓ | — | ✓ |
| Vacuum Resistance | — | ✓ | — | ✓ |
| Leak Testing | ✓ | — | ✓ | ✓ |
| Low Temperature Resistance Test | — | — | — | ✓ |
| Barrier Challenge Test | — | — | — | ✓ |
| Water Flow Test | — | — | — | ✓ |
| Cycle Test | — | — | — | ✓ |