PharmaTainer™ Bottle, Non-Sterile, 5/Vacuum-Sealed Pack - 2 Liter; 48 mm cap - 12709

Pharmatainer™ bottles are available in sizes ranging from 125 mL to 2 liters, made in PC. They are injection blow molded and capped in an ISO 5 cleanroom environment and then packaged in an ISO 7 cleanroom with inner layer vacuum sealed packaging. As per the manufacturer, they are designed for biomanufacturing liquid transfer, storage and transport. and the PC bottles, when used with a PP cap, can be autoclaved at a recommended 121C. Pharmatainer™ caps (part numbers 12716–12719) are available and feature barbed port configurations for use with these bottles. Technical Detail 2 Liter; 48 mm cap Materials PC HDPE 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) 84 Animal Derived Ingredients (BSE/TSE) 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 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 RoHS3 (2015/863) Conforms to requirements of RoHS 2015/863 (RoHS3) Gamma Compatible Yes X-Ray Compatible Yes Biocompatibility tested ISO 10993 Yes ISO 10993-X Claim Based on Raw Material USP Biocompatibility 87 Finished component passes USP<87> USP Biocompatibility 88 Passes USP <88>, temperature not stated 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 Contains NO ICH Q3D Class 1, 2, 2B or 3 Elemental Impurities Protein Absorption Data Available No Extractables Testing Claims Suitable for intended use according to USP <665> Visible-Subvisible Particulate Claim USP <788> Bioburden USP 61 62 Bioburden values available Tested via USP 661.1 No Integrity Tested? Yes, 100%