Temperature mapping should be carried out after any new installations, repair work or as part of a regular scheduled maintenance and monitoring programme.
The Risks of Not Storing Items at the Correct Temperature
An underperforming fridge is a detriment to performance, results and analysis. Medical products may not work correctly as the nature of the chemicals they contain may be altered if they aren’t stored at the right temperature. If there is a ‘use-by’ date on any of the medicines then this can no longer be relied upon if it’s been stored in a faulty fridge or freezer.
Problems are not just restricted to the medical world. Research which relies on items being kept at specific temperatures won’t be validated by the scientific community, and samples used in experiments could become unusable. The risks also apply to transportation and storage after the item is taken from the lab or manufacturing plant to the warehouse.
UKAS Accreditation for Temperature Mapping
Laboratories need to comply with a number of specific areas to meet the requirements of ISO 17025 and so gain their UKAS accreditation. These include:
- The qualifications, training and experience of the staff
- The right equipment, properly calibrated and maintained (this includes the data loggers themselves).
- Quality assurance procedures
- Sampling practices and testing procedures
- Traceability of measurements to national standards
- Accurate recording and reporting procedures
- Suitable testing facilities.
Some labs must have their equipment or environment temperature mapped by a UKAS-accredited lab because their governing body requires it; this includes the Human Tissue Authority, which regulates organ donation and transplants, and the Medicine and Healthcare Products Regulatory Agency (MHRA), which checks that medicines and medical equipment work and are acceptably safe.
Blood, and anything which is injected into people’s bodies, must also be stored in fridges which have been temperature mapped in line with UKAS’s temperature mapping requirements. Blood fridges especially must operate within narrow temperature ranges as blood products have a very short shelf-life if they aren’t effectively preserved.
However, microbiological fridges which store bacteria, viruses, fungi, algae and other microscopic organisms are not subject to such stringent rules. The Good Distribution Practice Guidelines, a Europe-wide code of standards aimed at ensuring the quality of a medicine is maintained throughout its distribution network, merely states that temperature mapping should take place, but not how this should be done (or who by).
The MHRA states that during their inspections of labs with microbiological fridges “it has become clear that some companies are unclear as to what is expected of them to comply with this requirement in the GDP Guidelines. This seems particularly apparent with new applicants and those companies with small storage areas, possibly a few shelves or small refrigerators.”
So, increasing numbers of microbiological fridges are being mapped in line with UKAS’s requirements as a way of ensuring that all samples are stored at the correct temperature. Microbiological samples, like medical products, can also easily lose their integrity if the temperature they are kept at varies, or if they are subjected to any type of ‘freeze-thaw’ process.
Temperature Mapping Services from Arena Instrumentation
Arena Instrumentation have many years of experience in offering temperature mapping services to the healthcare, pharmaceutical and scientific research sectors.
We have worked with over 80 NHS hospitals across the UK, supporting various departments including pathology labs, blood banks, pharmacies and mortuaries. As well as fridges and freezers, we also can check incubators, water baths, plasma thawers, stability cabinets and environmental testing chambers.
Our mapping takes place over 24, 48 or 72 hours, depending on the environment and our clients’ needs. Our maximum logging intervals are five minutes.
If you would like to know more about our services, follow this link. You can also call us on 0151 355 1314.