Optimal sample storage temperatures
A guide to pharmacy fridge temperature monitoring
Temperature mapping with SenseAnywhere
A Temperature Mapping report is a document that records and summarises the measurement of the temperature and/or relative humidity distribution within a storage area, including identification of hot and cold spots. The purpose of a temperature mapping study is to document the temperature distribution within a storage area. All mapping exercises should be fully documented in order to demonstrate compliance to management, clients, and the regulatory authorities. All new temperature-controlled storage areas must be temperature-mapped as part of a fully documented verification process before the installation is commissioned and handed over by the installer. Until this has been done, it is not approved to store time- and temperature-sensitive pharmaceutical products in such areas
Temperature mapping with
SenseAnywhere is an extremely efficient and economical mapping process requiring
a minimum of time and resources, quickly and clearly discovering possible
resist areas. The one click temperature mapping report generated in SAClient allows
users to make recommendations about the optimum storage locations for highly
sensitive products, and those that are less sensitive. Here, we will take a
look at some of the key pages found in the SenseAnywhere temperature mapping
report.
Report Summary
The report summary is one of the first pages in the temperature
mapping report and provides the key findings from the study. This page outlines
who the report was made for and at which location, as well as the mapping
details such as the technician who carried out the study, the date the study
was completed, number of loggers and more. Key data can also be viewed at a
glance on this page, for the batch of loggers the minimum, maximum, average,
spread, Mean Kinetic Temperature (MKT) and standard deviation (Std) are
calculated. The tables below show the lowest, highest and average values that
are found.
Dispersion chart
Another great feature of the temperature mapping report is the dispersion chart, this shows the total temperature spread of the loggers in light blue, with a small spread indicating good uniformity. The average line is the calculated average of all mapping loggers. The position of the average line, compared to the spread indicates if there is fluctuation between loggers. This information is of course incredibly handy for the user, identifying key information from the study.
Data Overview
In the mapping report data overview, you will find key information such as logger names and serial numbers, each individual loggers’ min, max and average temperature ratings, their pass/fail status, temperature spread, mean kinetic temperature (MKT) and standard deviation. Also listed are the outside loggers and the mapping logger chart- this chart shows all loggers included in the mapping study and allows users to visually analyse the temperature fluctuations.
Excursions
The excursions section of the report outlines any events by
which a data logger involved in the study recorded the temperature going either
over or under the set temperature limits. Any recorded events will of course be
cause for concern and rectifying action will need to be taken to ensure these
areas are adequately temperature controlled.
Hot Spots
Of course, the key aim of a temperature mapping report is to identify hot and cold spots in the storage unit. Hot Spots are used to find the hottest locations and can be identified in three different ways: Maximum, Average and Mean Kinetic Temperature. The Hot Spots can be different for each of these variables. This data is easily accessed on this page in both table and chart format.
Cold spots
Cold spots are the other areas to identify, and this section provides the same data so that the user is aware of the locations which are colder and to what degree. Allowing the user to assess how this may affect the storage of the products.
Stability Spots
This section of the temperature mapping report allows you to identify the loggers/ locations with the lowest stability or highest spread. The table identifies these loggers as well as showing the lowest and highest spread.
Logger analysis
The logger analysis shows the average temperature of all of
the loggers in every minute of the study. This provides the user with a
complete breakdown of the temperature conditions of the storage unit at all
times during the temperature mapping.
Calibration certificates
This section provides a copy of all of the calibration certificates of the loggers used in the temperature mapping report.
Summary
The SenseAnywhere mapping system can be set up in under 3 minutes and an in-depth temperature mapping report like this one can be generated in one click. The costs against the time saved not having to manually generate the report makes SenseAnywhere a very cost-effective system. The temperature mapping report does all the heavy lifting, providing all the data you need under one roof, making compliance a breeze. To further assist with compliance, you can reupload the certificate to the site for tamper verification making this a great mapping system. We sell the SenseAnywhere mapping system and also provide mapping services, find out more below.
