NEXCEL© BIO1250 is a robust bioprocessing film adaptable to a wide range of bioprocessing applications. This clear, co-extruded PE-based film with EVOH barrier resists stress whitening, scuffs and scratches. Manufactured in an ISO 7 cleanroom, NEXCEL© BIO1250 is gamma-stable, chemically resistant, biocompatible and has a low extractables and leachables profile. This film offers optimal seal strength, compatibility with a large range of port, tube and connector configurations, redundant barrier layers that fortify control of oxygen transmission and offers high performance even at temperatures reaching -80°C.
NEXCEL® is a registered trademark of Sealed Air Corporation (US).
| Technical Detail | 328.08 ft x 4.53 ft (100 m x 1.38 m); 1485.42 sq. ft. (138 sq. m) |
| Materials | PE |
| CAD Model Available | No |
| Packaging | 1485.42 sq. ft. (138 sq. m) |
| 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) | 24 |
| Animal Derived Ingredients (BSE/TSE) | 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. |
| 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 | Not tested for pyrogens |
| REACH SVHC | No Substance(s) Present Above Threshold |
| REACH SVHC Candidate List | 2024 November 07 (242 Substances) |
| RoHS3 (2015/863) | Conforms to requirements of RoHS 2015/863 (RoHS3) |
| Gamma Compatible | Yes |
| X-Ray Compatible | Yes |
| Biocompatibility tested ISO 10993 | No |
| USP Biocompatibility 87 | Finished component passes USP<87> |
| USP Biocompatibility 88 | Passes USP <88> 121C |
| 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 | Modified BPOG |
| Visible-Subvisible Particulate Claim | Information Not Available |
| Bioburden USP 61 62 | No bioburden information available |
| Tested via USP 661.1 | No |
| 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.
