Qosina part number 20510 is a high-performance fluid storage and transfer bag chamber ideal for bioprocessing applications requiring reduced risk of product loss, contamination and comprised quality for critical process fluids and high-value final products. Manufactured with gamma-stable fluoropolymer, this single-layer film does not contain curing agents, antioxidants, plasticizers, or adhesives. Additionally, 20510 has a low particle count, greatly reducing the potential for process fluid contamination. This film provides high purity, exceptional compatibility, increased safety, and has a wide operating temperature range of -196°C to 121°C, making it extremely durable in frozen applications. Featuring a fluoropolymer boat port design and including a hanging opening for improved handling, 20510 has comprehensive chemical compatibility including 100% DMSO.
| Technical Detail | 10 ml; Both Ports Fit 1/8 inch ID Tubing (0.125 inch, 3.18 mm) |
| Materials | Fluoropolymer Fluoropolymer |
| CAD Model Available | No |
| Manufacturing Environment Classification | ISO Class 5 / 100 / Grade A |
| 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) | 36 |
| Animal Derived Ingredients (BSE/TSE) | Certified Animal Derived Component Free (ADCF) |
| California Prop. 65 | Information Not Available |
| Conflict Minerals | Not known to contain tantalum, tin, tungsten or gold. |
| European Pharmacopoeia (EP) 3.1.X | Information Not Available |
| 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 | Does NOT intentionally contain nanomaterials |
| Pyrogens | Not Tested for Pyrogens |
| 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) | 40 |
| 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> 50C |
| USP Biocompatibility Claim Based On | Finished Component |
| 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 | Full BPOG BEDS |
| Visible-Subvisible Particulate Claim | USP <788> |
| Bioburden USP 61 62 | No bioburden information available |
| Tested via USP 661.1 | No |
| 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.
