Automated Cell Thawing System, Item No. MCS-630
The ThawSTAR® CFT1.5 Vial Thawing Instrument can be leveraged early in the R&D phase and scaled into commercial manufacturing and point of care. Cell size and choice of cryopreservation media can affect optimal thawing profile, viability, and function of a live drug product. Confidently thaw cells for the clinic, knowing that ThawSTAR instruments will undergo custom tuning using advanced algorithms for the specific cell therapy product under development, in order to ensure that the optimal thaw rate and cell health is achieved.
ThawSTAR CFT1.5 Transporter is a portable solution for the handling and transport of frozen vials from long-term storage in vapor phase liquid nitrogen or in a -80°C freezer to downstream processing with the ThawSTAR Automated Cell Thawing Instrument. ThawSTAR Transporter protects therapeutic cells from transient warming events during transport to ensure maximum cell health.
Features & Specifications
ThawSTAR® CFT1.5 Instrument
|Dimensions:||11.0 cm x 14.5 cm (5.7 in x 4.3 in)|
|Capacity:||1.5 mL cryogenic vial|
|Fill Volume:||0.5 - 1.5 mL|
|Thawing Time:||Less than three minutes|
|FDA Master File:||The Master File for all models of the ThawSTAR Automated CellThawing System has been registered to the United States (U.S.) Food and Drug Administration (FDA), Center for Devices and Radio logical 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 firstname.lastname@example.org.|
|Compliance:||CE mark (EMC and Safety), EN 60601-1-2, EN 61010-1, RoHS, WEEE|
|Voltage:||US, EU, UK|
ThawSTAR® CFT1.5 Transporter
|Dimensions:||11.4 x 15.0 cm (4.5 x 6.0 in)|
|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.