Technical Detail | 4.2 psi CP |
Materials | PC Silicone |
CAD Model Available | No |
Manufacturing Environment Classification | ISO Class 8 / 100,000 / Grade D |
Hazardous Goods | No |
Product Shelf Life Non-Irradiation (months) | No shelf life indicated by the supplier |
EU MDR 10.4.1 (CMR/ED) | No Substance(s) Present Above Threshold |
EU MDR 10.4.1 (CMR/ED) Substance List | Annex VI to CLP_ATP18 - 01 December 2023 |
European Pharmacopoeia (EP) 3.1.X | Information Not Available |
Latex | Does NOT intentionally contain natural latex |
Latex in Packaging | Does NOT intentionally contain natural latex |
PFAS | Does NOT intentionally contain PFAS |
PFAS in Packaging | Information Not Available |
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 |
Bioburden USP 61 62 | No bioburden information available |
Tested via USP 661.1 | No |
Integrity Tested? | No |
The products in our inventory are intended solely for use as components for further manufacturing, processing or incorporation into a finished device. These products are not intended for use as finished devices. Customers are solely responsible for determining whether a Qosina component product is appropriate for customer’s intended use and for ensuring that the use of the component product is in compliance with applicable laws. Our components are not available for sale to hospitals, physicians, and pharmacists.