Sani-Tech® SPT-60L is a premium platinum-cured silicone tubing designed for extended duration pumping including final filling. It provides best-in-class accuracy and precision to ensure consistent filling performance and reduces the potential for costly over or under fills. In addition, Sani-Tech® SPT-60L provides a long pump life, low spallation, and delivers ideal performance for the most demanding operations. As per the manufacturer Sani-Tech® SPT-60L is not intended to be used as part of an implantable device.
| Technical Detail | 60 A Durometer; 1/4 inch ID x 7/16 inch OD (0.25 inch x 0.438 inch, 6.35 mm x 11.11 mm) x 25 ft coil (7.62 m) |
| Materials | Silicone |
| CAD Model Available | No |
| Packaging | 25 ft coil (7.62M) |
| Manufacturing Environment Classification | ISO Class 7 / 10,000 / Grade C |
| Manufacturing Aids - Mold Release - Lubricant used | No |
| Colorant in Part | No |
| Regrind Used to Manufacture This Part | No |
| Hazardous Goods | No |
| Product Shelf Life Non-Irradiation (months) | 60 |
| Animal Derived Ingredients (BSE/TSE) | Certified Animal Derived Component Free (ADCF) |
| California Prop. 65 | NO SUBSTANCES on the California Proposition 65 list have been knowingly or intentionally added |
| California Prop. 65 List Date | 12/29/2023 05:00:00 am |
| Conflict Minerals | Not known to contain tantalum, tin, tungsten or gold. |
| 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_ATP20 - 01 February 2025 |
| European Pharmacopoeia (EP) 3.1.X | Pass 3.1.9 Silicone |
| Human Derived Ingredients | Does NOT intentionally contain human derived ingredients |
| Latex | Does NOT intentionally contain natural latex |
| Latex in Packaging | Does NOT intentionally contain natural latex |
| Medicinal Substances | Information Not Available |
| Nanomaterials | Information Not Available |
| PFAS | Does NOT intentionally contain PFAS |
| Pyrogens | Pyrogen free - Tested via USP <85> |
| REACH SVHC | No Substance(s) Present Above Threshold |
| REACH SVHC Candidate List | 2024 January 23 (240 Substances) |
| RoHS3 (2015/863) | Conforms to requirements of RoHS 2015/863 (RoHS3) |
| EtO Compatible | Yes |
| Gamma Compatible | Yes |
| Biocompatibility tested ISO 10993 | Yes |
| ISO 10993-X Claim Based on | Raw Material |
| USP Biocompatibility 87 | Raw materials pass USP <87> |
| USP Biocompatibility 88 | passes USP <88> 70C |
| USP Biocompatibility Claim Based On | Finished Component |
| Protein Absorption Data Available | No |
| Extractables Testing Claims | Full BPOG BEDS |
| Visible-Subvisible Particulate Claim | USP <788> |
| Bioburden USP 61 62 | Bioburden values available |
| 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.
