Monitoring the temperature of storage units
Guideline
Purpose and use of this guideline document
Where there is a requirement for the analysis or evaluation of clinical trial samples to be performed to
GCP standards, storage units (e.g. liquid nitrogen tanks, freezers and fridges) which are holding
clinical trial samples, standards, controls and key analytical reagents require temperature monitoring.
Many units will be fitted with electronic data loggers but it may be necessary to record temperatures
manually.
This document provides simple guidelines for the manual temperature monitoring of storage units and
can be used for the development and implementation of trial- and/or laboratory-specific written
procedures.
Record keeping
 Temperature records must be kept (either electronically or hard copy) and be available for
inspection. An example form is available for developing hard copy temperature records (see
UoB-CLN-LAB-QCD-031 Temperature Monitoring record).
 All records must be stored safely and securely throughout the trial and archived with the other
trial documents when the trial closes.
Developing written procedures
You are advised to include the following:
 The name or job title of the person(s) responsible for carrying out the monitoring and the
maintenance and storage of records (it is recognised that routine servicing are often carried
out by equipment manufacturers under service contracts, and records are kept centrally by
Technical Managers).
 Procedures developed from the guidelines below.
Adverse events
You are strongly advised to consider the actions to be taken should a storage unit fail and to develop
a separate trial-specific written procedure which should include information about who should be
notified and how and where samples may be transferred to. If there is a possibility that insufficient
back up space may be available then the recommendation is to decide a clear prioritisation of sample
salvage (to include standards, controls and reagents if they are affected also) and document this (see
UoB-CLN-LAB-QCD-019 Procedures following failure of storage unit).
You should also consider the impact failure of a storage unit may have on sample integrity or analysis
(see UoB-CLN-LAB-QCD-010 Impact assessment of equipment failure or equipment calibration
failure, UoB-CLN-LAB-QCD-016 Adverse events in the analytical laboratory, UoB-CLN-LAB-QCD-029
Impact assessment of equipment failure or equipment calibration failure and UoB-CLN-LAB-QCD-032
Adverse Event report).
Guidelines
 Ensure that the electronic temperature logger or thermometer being used is calibrated; either
itself certified to national standards, or calibrated against a certified thermometer (see UoBCLN-LAB-QCD-002 Equipment maintenance and calibration checks).
 Record the temperature every morning, preferably before the fridge, freezer or liquid nitrogen
tank has been opened.
Acceptable limits:
-80oC
-20oC
+4oC
plus/minus 10oC
plus/minus 3oC
plus/minus 3oC
UoB-CLN-LAB-QCD-003 Temperature monitoring v1.0 (EAv1.0)
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Monitoring the temperature of storage units
Guideline
If the temperature is out of the acceptable range:
o Record this information together with details of repairs (see example form UoB-LAB-QCD022).
o Consider whether an adverse event has occurred i.e. whether the storage unit has failed
or is failing. If so, this should be reported as an adverse event and procedures for failure
of a storage unit should be implemented (see guideline documents and example forms
UoB-CLN-LAB-QCD-010 Impact assessment of equipment failure or equipment
calibration failure, UoB-CLN-LAB-QCD-016 Adverse events in the analytical laboratory,
UoB-CLN-LAB-QCD-019 Procedures following failure of storage unit, UoB-CLN-LABQCD-029 Impact assessment of equipment failure or equipment calibration failure report,
and UoB-CLN-LAB-QCD-032 Adverse Event report).
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.
Related documents
 UoB-CLN-LAB-SOP-001 Procedures for GCP compliance in the laboratory
 UoB-CLN-LAB-QCD-002 Equipment maintenance and calibration checks
 UoB-CLN-LAB-QCD-010 Impact assessment of equipment failure or equipment calibration
failure
 UoB-CLN-LAB-QCD-016 Adverse events in the analytical laboratory
 UoB-CLN-LAB-QCD-019 Procedures following failure of storage unit
 UoB-CLN-LAB-QCD-021 Equipment maintenance record
 UoB-CLN-LAB-QCD-029 Impact assessment of equipment failure or equipment calibration
failure report
 UoB-CLN-LAB-QCD-031 Temperature monitoring record
 UoB-CLN-LAB-QCD-032 Adverse event report
UoB-CLN-LAB-QCD-003 Temperature monitoring v1.0 (EAv1.0)
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