The MHRA, Medicines and Healthcare Products Regulatory Agency are responsible for ensuring that medicines and medical devices work and are safe in the UK. This responsibility covers all MHRA wholesales and other distributors of time-temperature sensitive medical products.
To achieve a licence or authorisation from the MHRA for a product, the distributor must be able to provide evidence of and prove temperatures throughout the supply chain. This is because the state of many medical products can alter with changes in temperature, making it essential that the right temperature is maintained throughout transportation.
The pressure of providing this evidence is growing; products must be initially validated, the containers and vehicles or shipping routes must be checked along with the routine monitoring or shipments to ensure the deliveries are within acceptable limits.
Wessex Power offers a comprehensive array of temperature mapping equipment. These range from individual data loggers to full temperature monitoring systems that are chosen bespoke to fit your purposes. We can offer tailor packages to fit any budget including low cost temperature mapping packs and advice along with turnkey, real-time monitoring solutions linked to GPS.
These packages include:
- Wireless temperature monitoring
Our wireless temperature monitoring solutions meet MHRA standards and monitor temperature wirelessly, with reporting and alarm features commissioned with GxP documentation. They are simple to install and offer expansion when needed, enabling it to grow with your system and be accessed anywhere via the Cloud.
- Cold chain monitoring systems
These range from single and multiple use data loggers, simple stick on indicators and cloud based real time systems that meet your data recording requirements in cold temperatures. For example, -196°C Liquid Nitrogen vessels, dry ice shipments and freezers require cold chain monitoring that is reliable and can deliver optimum results in extreme conditions.
Choose what data is seen by who, as a detailed temperature report may not be relevant to everyone in the supply chain. Quality and validation departments, distribution networks and the receiver of goods will want to see whether the shipment temperature stayed within its limits. Data loggers can include a clear LCD screen and PDF reporting capabilities for ease of use.
Please call a temperature monitoring specialist at Wessex Power to discuss your needs or requirements and we will recommend a package for you. Call +44 (0)1929 459 459 or view our brochure for more information.