How do you conduct a temperature mapping study?

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How do you conduct a temperature mapping study?

Temperature mapping study

Temperature Mapping- A Three Stage Process

A temperature mapping study is conducted to comply with the requirements of GMP and GxP guidelines, by ensuring that any handling and storage areas are fully qualified and validated. Qualification of these areas safeguards the integrity of your products and prevents unnecessary spoilage and waste. You might be asked to demonstrate examples of these qualification studies by regulatory inspectors or during customer audits. Temperature mapping is a recognised industry standard process for the qualification of these spaces. The focus of a temperature mapping study is to characterise the temperature distribution within an area, identifying any hot or cold spots that could pose a risk to the safety or quality of your product. Mapping studies can be completed on an enclosed chamber such as a fridge or a freezer, as well as extend to much larger spaces including cold rooms and warehouses. The temperature distribution will be impacted by your ambient climate, which is often why mapping studies are conducted seasonally, usually covering a worst-case summer and winter scenario. A temperature mapping study is performed by distributing a suitable number of sensors throughout the area, ensuring the area is fully covered and recording data over a period of time. This data provides evidence to support the conclusion reached. There are three main stages of the process to ensure compliance.

1. Protocol

The first stage of the temperature mapping process involves reference to your Temperature Mapping Protocol. Your protocol is critical in establishing the key characteristics of your study including aspects such as your scope, objectives, test equipment, personnel required, number of sensors and sensor locations, study duration, acceptance criteria and reporting requirements. Like any SOP this document should be controlled and part of your wider Quality Management System, speak to your Quality department to understand whether you already have a protocol in place.

Your protocol will bespoke and unique to your facility, this is not a one size fits all approach and should differ between areas/spaces. It is normal for a site audit to be conducted to establish some key points such as where the highest point of storage is, location of items such as heaters and cooling vents, windows, doors, hinges and loading bays that may impact the temperature in the area. Areas including storage cupboards and mezzanine floors also need to be considered. These factors are all considered when deciding how many sensors to use and where to locate them.

If you do not have a protocol in place and need help writing one, then please get in touch as this is a standalone service that we can offer. It is crucial to ensure due diligence at this stage, any short-cuts or errors made here can risk the viability of the whole process. A protocol can be used more than once providing no significant changes have occurred since it was established.

2. Study

This part of the process involves the execution of your protocol as outlined above. You will need to schedule the study and ensure that you have the appropriate test equipment available and calibrated. Your protocol might not stipulate the exact model of data logger that should be used but it should outline the technical requirements of the datalogger. There are many different types of dataloggers available on the market suited to different applications. Each have their benefits and drawbacks, you need to consider battery life, memory size, method of programming, reliability, robustness, sample rate, reporting functions and of course cost. Another consideration is that large spaces can often require hundreds of sensors that may only be required for a week or two. An affordable solution may be to hire additional equipment for this period. Your equipment provider can advise you on the most suitable logger for your needs and ensure that the loggers are supplied with an appropriate calibration certificate. Withnell Sensors hires out a full range of equipment for projects such as this- but be sure to plan as the demand for sensors is seasonal with large projects often scheduled in advance.

You will also need to consider the placement and retrieval of the sensors; this can be done by an in-house team who follow your protocol or sometimes the entire mapping process is outsourced to a third party. A great tip when conducting your study, always verify that your dataloggers are collecting data before placing your sensors. Some loggers do offer live data which is particularly useful for large studies, there is nothing worse than getting to the end of your study and realising that some of your data loggers failed to collect data. It is an unnecessary deviation that can lead to costly delays and potentially the need for the study to be repeated.

3. Report

The mapping report can be compiled once all data has been downloaded and analysed. The format will be specified in your protocol and will include inputs for comments, observations, deviations, improvement actions and concluding statements. You should consider how you will download and archive your data as this can be very time consuming for larger studies. Your protocol might include guidance for this or your standard QMS procedures will stipulate the storage, retention and archiving of information. Your raw data will provide supporting evidence for your report and can be reviewed by auditors. It is important to get some input from someone who can interpret and understand the mapping data. This person is responsible for raising any improvement actions including the frequency of future studies, the need to review the protocol and any facility modifications that might be needed. The temperature mapping study will also identify where permanent temperature monitoring equipment should be positioned. The areas for permanent monitoring equipment will be where the product is most vulnerable to temperature deviations. In more extreme circumstances the exercise might identify areas that are unsuitable to store food, drugs and vaccines leading to the reconfiguration of your storage space.

For more information about how we can help you to deliver your temperature mapping requirements or to speak to us about the suitability of your data loggers then please do not hesitate to get in touch. We are available on our website through instant chat, via phone or email.