Qosina part number 28615 is a robust fluid storage and transfer bag chamber ideal for upstream and downstream bioprocessing applications. Manufactured with Flexsafe® S80 film, this multilayer film is composed of a polyethylene (PE) contact layer and co-extruded PE-EVOH-PE backbone structure, allowing for superior gas barrier properties. This film offers excellent biocompatibility, a low extractables profile, and superior strength and flexibility. It features a boat port design, made of PE, and includes a hanging hole for improved handling.
| Technical Detail | 50 ml; Both Ports Fit 1/4 inch ID Tubing (0.25 inch, 6.35 mm) |
| Materials | PE PE |
| CAD Model Available | No |
| Manufacturing Environment Classification | ISO Class 7 / 10,000 / Grade C |
| Manufacturing Aids - Mold Release - Lubricant used | Yes |
| Colorant in Part | No |
| Regrind Used to Manufacture This Part | No |
| Hazardous Goods | No |
| Product Shelf Life Non-Irradiation (months) | 36 |
| Product Shelf Life Post-Irradiation (months) | 36 |
| Animal Derived Ingredients (BSE/TSE) | Conforms with EMA/410/01 rev. 3 |
| California Prop. 65 | Information Not Available |
| Conflict Minerals | Not known to contain tantalum, tin, tungsten or gold. |
| European Pharmacopoeia (EP) 3.1.X | Pass 3.1.5 Polyethylene |
| 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 | Does NOT intentionally contain medicinal substances |
| Nanomaterials | Does NOT intentionally contain nanomaterials |
| Pyrogens | Pyrogen free - Tested via USP <85> |
| 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) | 45 |
| X-Ray Compatible | Yes |
| Biocompatibility tested ISO 10993 | Yes |
| ISO 10993-X Claim Based on | Finished Component |
| USP Biocompatibility 87 | Finished component passes USP<87> |
| USP Biocompatibility 88 | passes USP <88>, temperature not stated |
| USP Biocompatibility Claim Based On | Finished Component |
| Elemental Impurities: Tested via ICH Q3D Standard | Contains NO ICH Q3D Class 1, 2, 2B or 3 Elemental Impurities |
| Protein Absorption Data Available | No |
| Extractables Testing Claims | Other Report |
| Visible-Subvisible Particulate Claim | USP <788> |
| Bioburden USP 61 62 | No bioburden information available |
| Tested via USP 661.1 | Yes |
| Integrity Tested? | Yes, 100% |
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.
