Published on 16 févr. 2021 In: Trend
Temperature monitoring is a major issue for carriers who need to invest in high-performance traceability solutions. But what does the regulation say?
For many years, freight transport has been growing steadily, despite political, economic and health uncertainties. The industry is optimistic about the growth of the sector and is preparing to face new challenges. To meet these challenges, they are preparing to make numerous investments, particularly in IoT and Industry 4.0, representing over 25% of future investments. Indeed, the digitalization and automation of processes are underway in the transport sector, which is in full digital transition. The health crisis of 2020 and the development of vaccines against COVID-19 have contributed to accelerating this transition by forcing transporters to further secure the cold chain, for example to ensure the correct storage of vaccines throughout transport.
In this article, we propose to take stock of the cold chain traceability regulations and to focus on the transport and storage of pharmaceutical and food products.
For the transport and logistics sectors, ensuring cold chain integrity is a major issue, as it is closely linked to public health issues. When the cold chain is broken, it can quickly lead to the proliferation of bacteria and the degradation of foodstuffs. Unfortunately, transport is often the weakest link, as it is the most prolific time for cold chain breaks. Keeping goods at the right temperature throughout transportation is very complex and represents both health and economic challenges.
The transport and distribution of heat-sensitive goods are subject to different regulations that may vary according to the nature of the products, but also according to the country. European regulations require, among other things, the use of compliant temperature recorders that must be checked regularly. These two aspects, linked to the traceability of the cold chain, are the subject of standards called EN12830 for the recorders and EN13486 for their verification.
The EN12830 standard applies to temperature recorders used in the transport and storage of temperature-sensitive goods. This standard, dating from 1999, was revised in 2018 in order to define precise safety and integrity requirements that must be met by the recordings by this equipment. It is the responsibility of the user of these recorders to ensure their compliance with this standard. The manufacturer of temperature sensors must be able to provide a certificate of conformity issued by an accredited standards laboratory. In France, laboratories must be COFRAC-accredited in order to be authorized to issue a certificate of conformity in accordance with the law.
THE EN13486 STANDARD
The EN13486 standard, for its part, deals with the periodic verification of temperature recorders. Like any measuring device, temperature sensors can lose accuracy after a few years. Verification of these is the responsibility of carriers and logisticians and although it is not mandatory, it is strongly recommended. It is important to note that this verification must be performed by a certified metrology laboratory. (COFRAC for France). The frequency of verification depends on the user's requirements, however it is recommended to have the sensors verified every year if they have been used during the period.
Now that we have taken stock of the regulations, let's focus on 2 sectors of activity that are highly regulated in terms of transport and storage of foodstuffs: the pharmaceutical sector and the agri-food sector.
Health products and medications can be very expensive, fragile and need to be handled with the utmost care. Maintaining their temperature is essential to preserving their integrity. For example, some COVID19 vaccines against require extreme storage temperatures (up to -70°) and are currently the focus of considerable attention. According to the World Health Organization, nearly half of the vaccines distributed worldwide have had to be thrown away, among other reasons, because of cold chain traceability problems. To meet this global challenge, transporters are equipping themselves with ever more effective temperature monitoring solutions to ensure the viability of vaccines.
As far as the food industry is concerned, the regulations are also very strict in terms of the cold chain integrity, whether for fresh, cold or frozen products. Temperature monitoring is an important issue to prevent possible health crises as well as food waste in case of a break in the cold chain. In France, more than 50% of foodstuffs are thrown away before they are even put on the shelves because of poor monitoring of the cold chain.
The health crisis of 2020 has prompted many players in the transport sector to equip themselves with innovative solutions to further secure the delivery and storage of vaccines against COVID19. The IoT's manufacturers have developed new temperature sensors that can reach extra-wide measurement ranges to meet this urgent need.
But how do these cold chain traceability solutions work?
Today, wireless communication technologies such as Bluetooth Low Energy (BLE) allow the remote monitoring of transport and storage temperatures in a simple and fast way. As the BLE protocol is an open protocol available on all smartphones, it simplifies the reporting of temperature data. Indeed, the carrier can retrieve the measurement history by scanning the Bluetooth temperature sensor which can be positioned either in the truck trailer or in transport boxes. These wireless solutions make it possible to know in real time the temperature at which products are stored and to be alerted by sms or email if a threshold is exceeded.
Some manufacturers of temperature sensors, such as ELA Innovation, also offer products that can be quickly interfaced with the GPS trackers used in truck fleets for example. The GPS tracker acts as a 3G gateway by transmitting temperature data back to the client server.
For transport and logistics professionals, equipping themselves with temperature monitoring solutions has become essential to ensure the safety of goods and to facilitate temperature monitoring. It is nevertheless important to pay particular attention to the choice of sensors, to ensure that they comply with the standards and regulations in force.
Published on 16 févr. 2021 In: Trend
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