Transport and Cell Thawing System for Cell Therapy Products, Item No. MCS-620
ThawSTAR® AT6 Transport and Thawing System for AT-Closed Vial® improves the overall handling of cell therapies by combining the 6ml AT-Closed Vial technology with MedCision’s breakthrough cell therapy thawing system.
When thawing cells in a clinic, your thawing protocol should meet the same high standards of care used during sample collection and cryopreservation. The ThawSTAR® AT6 Thawing Instrument replaces unstandardized manual methods with controlled profile thawing, and can be leveraged early in the R&D phase and scaled into commercial manufacturing and point-of‑care. For clinical applications, ThawSTAR instruments can incorporate custom tuning using advanced algorithms for the specific cell therapy product under development. Ensuring that the optimal thaw rate and cell health is achieved protects the integrity of therapeutic cells while mitigating risk to the patient.
Features & Specifications
ThawSTAR® AT6 Instrument
|Dimensions:||11.0 cm x 14.5 cm (5.7 in x 4.3 in)|
|Capacity:||6.0 mL AT-Closed Vial®|
|Vial Compatibility:||Aseptic Technologies|
|Fill Volume:||2.0 - 6.0 mL|
|Thawing Temperature:||37°C, or custom setting|
|Thawing Time:||Approximately 6 - 10 minutes|
|FDA Master File:||The Master File for all models of the ThawSTAR Automated Cell Thawing System has been registered to the United States (U.S.) Food and Drug Administration (FDA), Center for Devices and Radiological Health (CDRH) under the reference number MAF2643. If you are submitting an investigational new drug (IND) application or a biologics license application (BLA) to the U.S. FDA, and need a cross-reference letter to our Master File, please contact us at email@example.com.|
|Compliance:||CE mark (EMC and Safety), EN 60601-1-2, EN 61010-1, RoHS, WEEE|
|Voltage:||US, EU, UK|
ThawSTAR® AT6 Transporter
|Dimensions:||20.0 x 16.0 x 16.0 cm (7.8 x 6.3 x 6.3 in)|
|Dry Ice||~250 g|
|Holding Temperature||< -70°C|
|Holding Time||> 1 hour|
This product is for laboratory research use only. Any intended use for diagnostic purposes, direct transfusion, or in the production of therapeutic product(s) or vaccines(s) may require advance regulatory clearance which is the sole responsibility of the user, as this is not a medical device that has undergone medical device registration, clearance, or approval by the U.S. Food and Drug Administration (FDA), European Union, Health Canada, or the Australian Therapeutic Goods Administration.