Qosina part number 91318 is a gamma-stable magnetic stir bar ideal for mixing in open and closed bioprocess containers such as media bottles, carboys, flasks and bags. This item features a compact design and helps reduce setup times, costs and eliminates the need for cleaning validation with its single-use design. The PVDF contact material is certified animal-derived component-free (ADCF) and meets USP Class VI requirements.
| Technical Detail | 8 mm x 51 mm |
| Materials | PVDF Magnet |
| CAD Model Available | No |
| 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 | Information Not Available |
| Hazardous Goods | No |
| Product Shelf Life Non-Irradiation (months) | No shelf life indicated by the supplier |
| Product Shelf Life Post-Irradiation (months) | 24 |
| 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 12:00:00 am |
| Conflict Minerals | Information Not Available |
| 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 | Information Not Available |
| Human Derived Ingredients | Information Not Available |
| Latex | Does NOT intentionally contain natural latex |
| Latex in Packaging | Information Not Available |
| Medicinal Substances | Information Not Available |
| Nanomaterials | Information Not Available |
| Pyrogens | Not Tested for Pyrogens |
| REACH SVHC | No Substance(s) Present Above Threshold |
| REACH SVHC Candidate List | 2024 January 23 (240 Substances) |
| RoHS3 (2015/863) | Information Not Available |
| EtO Compatible | Yes |
| Gamma Compatible | Yes |
| Gamma Maximum Dosage (kGy) | 50 |
| Biocompatibility tested ISO 10993 | Yes |
| ISO 10993-X Claim Based on | Raw Material |
| USP Biocompatibility 87 | Information Not Available |
| USP Biocompatibility 88 | passes USP <88> 50C |
| USP Biocompatibility Claim Based On | Raw Material |
| 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 | USP <788> |
| 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.
