Invitation to tender for the provision and support of 2 x Controlled Rate Freezer Instruments for the Cryobiology Laboratory at St James’s Hospital.

Descriptions

The controlled rate freezers in the Cryobiology Laboratory are used for the cryopreservation of clinical products for transplantation including; BM, PBSC, DLI and CAR-T cell products. The units are cryopreserved in specialist cryopreservation bags (1-11 blood bags 250/500/750 mls & 4 pilot cryovials).The control rate freezer (CRF) is a critical component in the cryopreservation of irreplaceable patient or donor cells for transplant. The capacity for freezing large numbers of products has increased over the years as both National allogeneic & Autologous stem cell treatment programmes have expanded within the hospital. The current controlled rate freezers (2 units) require replacement to allow continued safe operation of the service. The CRF units must be medical device grade, CE marked and designed for the cryopreservation of clinical grade products.The most critical event for the preservation of the viability of cells occurs during the freezing and thawing process. The controlled rate freezer must be capable of holding password protected validated protocols which allow for a decrease in temperature in the freezing compartment from room temperature to below -180C at a fixed rate of 1 degree per minute. Cooling rates of -0.01 to -50oC per minute to -180oC and heating rates of 0.01 to 10oC per minute are required with the capacity to start the profile at temperatures above ambient. The rate freezer run capacity required is to hold 1-11 blood bags (250/500/750 mls) placed in individual freezing plates which allows for cryopreservation of the cells as a uniform thin film. There must be a temperature probe present in the freezing chamber to record the actual versus the expected run temperatures. A CRF controller unit or inbuild VDU must be supplied. A temperature profile of the run data must be available during and post run. The run data should be held in memory in the event of a power outage. The generation of a pdf of the run data and the back up of a print version should be available. An audible