The ThawSTAR CFT2 Thawing System 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. Several factors including cell size and choice of cryopreservation media can affect the optimal thawing profile, viability, and function. ThawSTAR instruments will undergo custom tuning using advanced algorithms for the specific product under development, in order to ensure that the optimal thaw rate and cell health is achieved.
ThawSTAR CFT2 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 Thawing Instrument. ThawSTAR Transporter protects cells from transient warming events during transport to ensure maximum cell health.
ThawSTAR® CFT2 Cell Thawing System
Product Catalog
Part Number:
AST-601
Dimensions:
11.0 cm x 14.5 cm (5.7 in x 4.3 in)
Color:
White
Capacity:
1.8 – 2.0 mL cryogenic vial
Vial Compatibility:
Compatible with major vial manufacturers
Fill Volume:
0.8 – 1.5 mL
Thawing Time:
Less than three 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 gzxbio@126.com.
Compliance:
CE mark (EMC and Safety), EN 60601-1-2, EN 61010-1, RoHS, WEEE
Voltage:
US, EU, UK
ThawSTAR® CFT2 Transporter
Part Number:
AST-602
Dimensions:
11.4 x 15.0 cm (4.5 x 6.0 in)
Color:
Blue
Dry Ice
~150g
Holding Temperature
<-70°C
Holding Time
> 1 hour
ThawSTAR® Instrument Power Supply and Adaptor
Part Number:
AST-606
ThawSTAR® CFT2 IOPQ Packet
Part Number:
AST-614
Dimensions:
Instrument: 11.0 cm x 14.5 cm (5.7 in x 4.3 in) / Transporter: 11.4 x 15.0 cm (4.5 x 6.0 in)
Color:
White
IOPQ Packet Contents Include:
Protocol Body section to capture the purpose, scope and strategy for qualifying the instrument
Sub-sections to record references, your organization’s SOPs, protocol execution requirements and overall qualification procedures
Qualification personnel, equipment, and material documentation forms
IOPQ Data Sheets
Qualification Packet Overview, Execution Deviation Form Template, and Qualification Summary Report Template