Materials PVC ePTFE CAD Model Available No Manufacturing Environment Classification ISO Class 8 / 100,000...
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| Materials | PVC ePTFE |
| CAD Model Available | No |
| Manufacturing Environment Classification | ISO Class 8 / 100,000 / Grade D |
| Manufacturing Aids - Mold Release - Lubricant used | No |
| Colorant in Part | No |
| Regrind Used to Manufacture This Part | Yes |
| Hazardous Goods | No |
| Product Shelf Life Non-Irradiation (months) | 60 |
| European Pharmacopoeia (EP) 3.1.X | Information Not Available |
| Pyrogens | Not tested for pyrogens |
| EtO Compatible | Yes |
| Gamma Compatible | Yes |
| Residual Solvents: Tested via ICH Q3C Standard | No ICH Q3C Testing Performed |
| Elemental Impurities: Tested via ICH Q3D Standard | No ICH Q3D Testing Performed |
| Protein Absorption Data Available | No |
| Extractables Testing Claims | No Extractables Testing Performed |
| Visible-Subvisible Particulate Claim | Information Not Available |
| Tested via USP 661.1 | No |
| Integrity Tested? | No |