ThawSTAR CFT2 IOPQ Kit

STEMCELL Technologies offers this qualification kit to support installation, operational, and performance qualification of the ThawSTAR® CFT2 Automated Thawing System. The kit provides documentation and accessories to facilitate functional testing of the instrument, helping users record instrument performance and maintain an audit trail before and after each thaw session.

Functional performance of the ThawSTAR® CFT2 system has been demonstrated across multiple cell types retrieved from liquid nitrogen storage following cryopreservation in CryoStor® CS10. Frozen peripheral blood mononuclear cells (PBMCs) cryopreserved at 3 x 10⁷ cells/vial yielded a mean of 2.78 x 10⁷ live cells with 92.8% viability using the automated system, compared with 2.96 x 10⁷ cells and 93.9% viability in a water bath. Frozen monocytes cryopreserved at 2 x 10⁷ cells/vial gave a mean live cell recovery of 2.05 x 10⁷ cells and 95% viability with the automated system, versus 1.89 x 10⁷ cells and 94.6% viability with a water bath. Human pluripotent stem cells (hPSCs) cryopreserved at 1 x 10⁶ cells/vial showed a mean live cell recovery of 9.05 x 10⁵ cells and 83.04% viability on the automated system, compared with 9.35 x 10⁵ cells and 82.93% viability in a water bath. All cell counts and viabilities were assessed using a Nucleoview counter across three donors or cell lines tested in triplicate.

The kit is designed for use in workflows involving frozen vial handling and transport from liquid nitrogen or -80 °C freezer storage, automated cell thawing, and cryogenic storage in internally threaded, self-standing polypropylene vials.