Materials | PC Colorant ABS ABS Colorant Acetal Silicone |
CAD Model Available | No |
Manufacturing Environment Classification | ISO Class 7 / 10,000 / Grade C |
Manufacturing Aids - Mold Release - Lubricant used | No |
Colorant in Part | Yes |
Regrind Used to Manufacture This Part | No |
Hazardous Goods | No |
European Pharmacopoeia (EP) 3.1.X | Information Not Available |
Medicinal Substances | Does NOT intentionally contain medicinal substances |
PFAS in Packaging | Does NOT intentionally contain PFAS |
REACH SVHC | No Substance(s) Present Above Threshold |
REACH SVHC Candidate List | 2023 June 14 (235 Substances) |
EtO Compatible | Yes |
Gamma Compatible | Yes |
Biocompatibility tested ISO 10993 | No |
USP Biocompatibility 87 | Raw materials pass USP <87> |
Residual Solvents: Tested via ICH Q3C Standard | No ICH Q3C Testing Performed |
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.