Mobius® 2D Freeze Assembly for Frozen Liquid Transportation and Storage
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Overview
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The Mobius® 2D Freeze single-use assembly offers a robust freeze and thaw solution that allows safe storage and transportation of your valuable product at a very low temperature. Combined with the RoSS® (Robust Storage and Shipping) shell, this solution enables easy and safe bulk drug substance and product transfers between multiple sites providing flexibility and security to your processes.
Available in 1 L, 5 L, 10 L, and 20 L sizes, the standard Mobius® 2D Freeze assembly is made with our PureFlex™ film and is Helium integrity tested to assure integrity will be maintained at temperatures down to -80 °C during freezing, storage, transportation, and thawing.
| Mobius® Bag Size | 1 L | 5 L | 10 L | 20 L |
| Part Number(s) | FRZ0001L001P5 | FRZ0005L001P5 FRZ0005L002P5 |
FRZ0010L001P5 FRZ0010L002P5 |
FRZ0020L001P5 FRZ0020L002P5 |
| Maximum Filling Volume* | 0.9 - 1.0 L | 3.7 - 4.0 L | 7.2 - 7.4 L | 11.7 - 12.2 L |
| Bag Dimensions | 6 in. W x 12.3 in. H | 12.5 in. W x 12 in. H | 11.5 in. W x 21.75 in. H | 16.5 in. W x 23 in. H |
| Operating Temperature inside RoSS® Shell | 112-140 °F (-80-60 °C) | |||
| Certification Level | Gold Certification with Helium Integrity Testing | |||
| Shelf Life | 2 Year Shelf Life | |||
| Integrity Testing | 100% assembly integrity tested using Helium as a tracer gas | |||
| Sterility | Sterility using a validated gamma irradiation level of 25-40 kGy | |||
| USP<85>Endotoxins, USP <788> Subvisible Particulates | 1 assembly per lot tested, post-gamma irradiation | |||
| USP<88> Biological Reactivity in vivo (Class VI),USP <661> Physicochemical Tests | Post-gamma irradiation | |||
| Bioburden | Post-gamma irradiation | |||
| Bacteriastasis/Fungistasis | Post-gamma irradiation | |||
| For reference only: FRZ000X1P5 has the aseptiquik connector and FRZ000X2P5 has the Lynx connector. That is the only difference between the two part numbers. Therefore all other information will be the same | ||||