Chamber Mapping
Ensure quality and control with temperature chamber mapping
Temperature mapping reports are a requirement for all spaces newly allocated for the storage and handling of products with a specified (often labelled) storage temperature.
Chamber mapping is one example of a space that requires temperature validation to identify the areas within the chamber which may be hot or cold and therefore impact the samples stored within them. This includes all types of chambers used across the various sectors, such as stability chambers, environmental test chambers, walk-in chambers and reach-in chambers.
Chamber mapping is the process of documenting and validating the temperature distribution throughout a chamber to determine the areas which may be hotter or colder. The data collected in a chamber mapping study identifies which areas may impact the samples when being tested in the chamber, enabling precautions to be taken to eliminate the risk of invalid testing results.
Depending on the regulatory requirements surrounding the sector and the type of testing and/or storage conducted, routine mapping may be required annually or seasonally to demonstrate continuing compliance.
Chamber mapping protocols are governed by WHO and ISPE, and a temperature mapping report is required for compliance with sector-specific authorities, including GMP, FDA, UKAS, ISO, etc.
As temperature and humidity specialists, we provide specialised chamber mapping services, or we can offer temperature mapping equipment for you to conduct your own chamber mapping. We will also help you navigate and deliver on the regulatory, operational and quality control requirements following the WHO and ISPE guidelines.
What is chamber mapping?
Chamber mapping is the periodic documentation and validation of chambers where conditions like temperature and humidity are mandated for regulatory compliance.
If there are hot or cold spots identified during mapping, it then enables the early detection of any performance issues or faults with the equipment to enable quick resolution before they become bigger, more costly issues, for both the equipment and the samples within the chamber.
Mapping is designed to help detect and correct the deviations from the parameters of the study you are conducting, whether it be an environmental or stability, Longitudinal storage or shelf-life testing.
In the pharmaceutical and life sciences sectors, chambers are used to test vaccines, medications, and biological samples, even equipment such as medical devices to test their longevity and the ageing process. In wider markets such as food and beverage, chambers are used for ongoing storage, in-process manufacturing and much more.
Why are temperature mapping studies necessary?
Chamber mapping studies are essential in the food, pharmaceutical, life sciences and many other sectors, as they ensure the quality of your product.
By mapping the temperature distribution of your chambers you can guarantee that your products and samples are stored and tested under optimal conditions throughout their shelf life.
Studies should be conducted seasonally or following a significant change to the chamber to ensure no new risks are present. Reports of validation may also be required by quality assurance departments, auditors and often even your customers too.
Steps for effective chamber mapping
You must conduct a mapping study to assess that your premises or facilities are built to withstand temperature changes. It is as important to conduct mapping reports annually or seasonally to ensure your chosen continuous monitoring system is capable of detecting any type of temperature change inside your facility.
Pre-mapping prep:
Before any chamber mapping study takes place it is important to identify what the regulations and requirements are that you must comply with. Once this is understood, you can determine the parameters of your study, such as, how many data points you need to collect from, how many data loggers you will need to place, how long the study should be and the testing schedule.
During a chamber mapping study
It is important to initially run your chamber on empty to establish your baseline conditions and conduct a primary test to ensure the equipment is functioning correctly.
With strategic placement of your data loggers you will then gain an accurate reading across the entire chamber.
The data loggers should take readings automatically at regular intervals throughout the defined study period, this duration will be dependent on the regulations and requirements you must comply with, this typically varies between 24 hours and a few days
Post chamber mapping study
After the data collection is complete, the results must be analysed to assess the temperature distribution across the chamber, identifying the uniformity and any deviations that must be addressed.
Why choose Withnell Sensors to conduct your chamber mapping study?
At Withnell we validate an extensive range of UKAS calibration equipment specifically for outsourced chamber mapping services. We can also provide you with the right guidance to identify a logger for you to perform your own mapping.
Our engineers can come to your facility, conduct a WHO/ISPE-designed mapping service that delivers the right support, data and advice for your ongoing monitoring.
We offer three levels of service, Bronze, Silver and Gold, so you can be sure to get the right service for you.
We can perform mapping on a variety of areas, whether it be your chambers, or storage rooms, warehouses, blood banks, cold rooms and more!
Want to conduct your own chamber map?
We also work with a range of market-leading brands so that we can offer an extensive portfolio of products to suit your chamber mapping needs. So, if you’re planning to map your own chambers or require fairly regular mapping, you can purchase your own equipment.
Chat with our engineers to determine the best product for your chambers, we offer unbiased guidance and advice.
Contact us today!
