Qosina part number 28700 is a high-performance fluid storage and transfer bag chamber ideal for upstream and downstream bioprocessing applications. Manufactured with medical-grade Renolit 9101 film, a multilayer film composed of high-purity biocompatible polyethylene (PE) contact layer with internal ethylene vinyl alcohol (EVOH) oxygen barrier, this film provides superior clarity, flexibility, strength, chemical resistance, stability in a temperature range of -45°C to 60°C and an extremely low extractables and leachables profile. It features a TruFLO port design, made of POE, which facilitates optimized edge-seal integrity and superior flow rates. This bag includes a robust PP hanging grommet for improved handling.
| Technical Detail | 50 ml; Both Ports Fit 1/8 inch ID Tubing (0.125 inch, 3.18 mm) |
| Materials | PE Polyolefin PP |
| 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 | No |
| Hazardous Goods | No |
| Product Shelf Life Non-Irradiation (months) | 60 |
| Product Shelf Life Post-Irradiation (months) | 24 |
| Animal Derived Ingredients (BSE/TSE) | Conforms with EMA/410/01 rev. 3 |
| California Prop. 65 | NO Substances on the California Proposition 65 list have been knowingly or intentionally added |
| 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 |
| RoHS3 (2015/863) | Conforms to requirements of RoHS 2015/863 (RoHS3) |
| Gamma Compatible | Yes |
| Gamma Maximum Dosage (kGy) | 50 |
| Biocompatibility tested ISO 10993 | Yes |
| ISO 10993-X Claim Based on | Raw Material |
| USP Biocompatibility 88 | passes USP <88>, temperature not stated |
| USP Biocompatibility Claim Based On | Raw Material |
| Extractables Testing Claims | Other Report |
| Visible-Subvisible Particulate Claim | USP <788> |
| Tested via USP 661.1 | Yes |
| Integrity Tested? | Yes, routine random samples are tested |
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.
