Attention quality control enthusiasts! MedCision has just announced the release of an IOPQ Packet for their ThawSTAR® Automated Cell thawing System. IOPQ (Installation/Operational/Performance Qualification) packets are designed to guide labs through qualification procedures for instruments to help laboratories comply with regulatory standards.
The ThawSTAR IOPQ Packet contains over 150 pages of documentation and step-by-step testing procedures that will assist ThawSTAR® System users in ensuring their system is functioning as expected, and if they wish, use the outcome of this qualification process to support the system’s intended use indicated in their GxP process. Guidelines for integrating the ThawSTAR® CFT2 Transporter into the qualification process are also included, along with customizable protocol templates, data sheets, and other support documents.
For scientists working in in pre-clinical development, or simply in the cellular therapy field, compliance with GMP standards takes on increasing importance. Cell-based systems are notoriously variable, and adopting the strict standards of a GMP cell culture facility early on should help eliminate delays later, at a potentially more critical stage of the research process.
ThawSTAR® Systems are designed to reduce process variability by standardizing cell thawing after cryopreservation. Achieving a reproducible thaw temperature for each vial of cells, or for vials being thawed from different temperatures, reduces variability and promotes cell viability and recovery. Access to the IOPQ Packet can help improve compliance under GxP regulations, by supplying all of the necessary testing accessories and material documentation forms.
The new IOPQ Packet can be ordered as part of the ThawSTAR® Complete System, or purchased separately at need. For more information on the ThawSTAR IOPQ Packet, please read here.