Temperature Mapping Kits

Description

SNBTS requires to procure temperature mapping kits to allow temperature controlled environments to be mapped in line with Good Manufacturing Practice (GMP) and the Blood Safety and Quality Regulations (BSQR). Temperature mapping is a regulatory requirement non-specifically referred to in GMP in sections such as validation and elsewhere e.g. EudraLex, vol 4, 3.19: “Where special storage conditions are required (e.g. temperature, humidity) these should be provided, checked and monitored.” Mappings typically require a minimum of 24 hours for a single system (incubator, fridge etc); to 2 days for cold rooms using dual refrigeration systems (evaporators and condensers). Cold rooms require a minimum of 3 days per refrigeration system. Warehouse areas require a minimum of 7 days, with mappings carried out at different frequencies to capture seasonal changes. SNBTS can be required to complete in excess of 400 mapping events per year. This is for mainly annual mapping but also incorporates additional mapping events as required. It is estimated that a typical week will require completion of 5 maps per week, per technician (with up to 2 technicians performing mappings). It should be noted that larger areas may require the use of multiple mapping kits due to the large number of temperature probes / data loggers required to ensure complete coverage of the temperature controlled storage area. Mapping kits and their associated software must be able to support a quick turnaround for mapping events. With respect to the hardware, equipment should facilitate easy programming and set-up prior to use, with online interrogation of data. Software should facilitate quick and easy retrieval of data which can be compiled into a single report which covers all of the probes with statistical analysis (min / max / average temperatures for each probe) without requiring manual manipulation of data to determine the overall results. The reporting software should also be able to provide a ‘Pass’ / ‘Fail’ decision based on the initial programmed details and the data captured.