Technical Detail | 60 ml; 1.9 inch Opening (48 mm) |
Materials | HDPE PP |
CAD Model Available | No |
Colorant in Part | Yes |
Hazardous Goods | No |
Animal Derived Ingredients (BSE/TSE) | Conforms with EMA/410/01 rev. 3 |
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 |
REACH SVHC | No Substance(s) Present Above Threshold |
REACH SVHC Candidate List | 2023 June 14 (235 Substances) |
RoHS3 (2015/863) | Conforms to requirements of RoHS 2015/863 (RoHS3) |
Gamma Compatible | Yes |
Gamma Maximum Dosage (kGy) | 20 |
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 |
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.