human biomaterials
Purpose:
Storage units (e.g. liquid nitrogen tanks, freezers and fridges) which are holdinghuman biomaterialsrequire temperature monitoring. Temperature records should be kept (either electronically or hard copy) and stored safely and securely.
Many units will be fitted with electronic data loggers, but it may be necessary to record temperatures manually.This document provides simple guidelines for manual temperature monitoring and can be used for the development and implementation of study-specific written procedures.Anexample form is available for developing hard copy temperature records is available(see UoB-RHB-QCD-006 Temperature monitoring record for further information)
Guidelines:
Calibration of temperature logger/thermometer
The electronic temperature logger or thermometer being used to monitor the temperature of the storage unit must be calibrated. Some may be calibrated and certified externally and but it is likely that some will require in-house calibration against a certified thermometer (see UoB-RHB-QCD-007 Calibration of thermometers and temperature probes and UoB-RHB-QCD-008 Thermometer and temperature probe calibration for further information)
Manual temperature recoding
Record the temperature every morning, preferably before the fridge, freezer or liquid nitrogen tank has been opened(see UoB-RHB-QCD-006 Temperature monitoring record for further information)
Acceptable limits:-80oCplus/minus 10oC
-20oCplus/minus 3oC
+4oCplus/minus 3oC
If monitoring is missed for any reason, indicate this on the records with a statement such as ‘not taken’ or ‘not carried out’ so that the record is not left blank.
Adverse events
Consider the actions to be taken should a storage unit fail and develop a written procedure which should include information about who should be notified and how and where samples may be transferred to (see UoB-RHB-QCD-009 Procedures following failure of a storage unit for further information)
Related documents:
UoB-RHB-SOP-001 Research using Human Biomaterials SOP
UoB-RHB-QCD-006 Temperature monitoring record
UoB-RHB-QCD-007 Calibration of thermometers and temperature probes
UoB-RHB-QCD-008 Thermometer and temperature probe calibration check record
UoB-RHB-QCD-009 Procedures following failure of a storage unit
UoB-RHB-QCD-005 Temperature monitoring of units storing human biomaterials v1.0 / Page 1 of 1