Transport of meds in controlled temperature – all you need to know to reduce the risk

Transport of meds in controlled temperature is one of the most demanding types of transport on the market. Not every carrier can transport meds, because pharmaceutical transport requires special expertise and training, as well as needs to be supported by relevant certificates.

Controlled temperature – the crucial risk factor in transport

Pharmaceutical transport imposes specific requirements relating to transport conditions on the carrier. Controlled temperature is – besides humidity – the most important element in transport of medicinal products which need to be taken into account. This is caused by the specificity of pharmaceutical products. Each deviation from the set temperature poses a risk of damaging a product or of causing dangerous modifications in its composition. In order to reduce the risk of deterioration of the quality of transported pharmaceutical products, a number of criteria to be met by the carrier have been implemented. They are associated with the guidelines of the Good Distribution Practice, which need to be adhered to at each stage of distribution.

What are the most common temperature ranges for transporting meds?

• +2C/+8C – the so-called cold supply chain
• +15C/+25C

Each participant of the supply chain of a medicinal product should be aware of the importance of adhering to strict conditions of transporting meds, including appropriate transport temperature. When we go to the pharmacy, we all want to get a top-quality product. The driver, the forwarder, each individual who takes part in the transport process, is obliged to know that even the slightest deviation from the set temperature may cause dangerous chemical modifications, which in turn might be harmful for patients’ health or lives, and it is patients who are the end recipients of the goods we transport.

A carrier aware of this risk should make sure that appropriate transport temperature is maintained during the entire transport process. Temperature should be constantly monitored and controlled.

Temperature transport of medicinal products – requirements for vehicles

Transport of meds entails a number of requirements that need to be satisfied by vehicles taking part in the distribution process. Each refrigerated truck taking part in transport of meds is obliged to have the following documents:

• ATP certificate – under ATP requirements, each vehicle should satisfy specific requirements pertaining to thermal insulation, and the cooling unit should secure lowering and maintaining the temperature inside at a required level.
• certificate of temperature sensors calibration – the goal of calibration is to define the level of measurement deviations on a given temperature sensor
• certificate of the cargo space mapping, carried out in summer and winter conditions – mapping is a process of testing the stability of the microclimate (temperature and humidity) in isotherms at representative points (with the highest risk of deviations) in representative weather conditions (the highest and lowest temperature and humidity possible).
• cleaning and disinfection logbook with current entries – each refrigerated truck has its own logbook, where all cleaning and disinfecting procedures are recorded

Besides the documents listed above, temperature control devices are an extremely crucial element:

• GPS systems, allowing to control temperature 24/7 and to set an alert notifying on an uncontrolled drop/rise of transport temperature
• printer allowing drivers to generate control printouts during transport

Temperature transport vs. human factor

Man is always the most important factor securing appropriate transport conditions; therefore, well-trained forwarders and drivers, supported by technology, guarantee a successfully provided service,

How is it done?

During transport, forwarders can fully control temperature thanks to telematic devices. Thanks to the GPS system, at each stage of transport it is possible to control temperature remotely, to generate a control temperature printout from the IT system. After each loading, the forwarded has an option to set an alert, which will inform them on even the slightest deviation from the set temperature in a text message.

Pharmaceutical transport – risk analysis in the process of transport

When planning routes and the entire drug distribution process, the risk of unexpected situations which might impact the quality of the service should be accounted for. It is necessary to study the risks and to be aware of them, as it can facilitate all actions undertaken in such an event.

Transport of meds entails the risk of the following situations:

• failure of the cooling unit or other elements of the cold room
• accident
• theft
• tampering with the goods by third parties
• goods contamination
• failure to satisfy appropriate transport conditions

Planning of routes and of the entire meds distribution process is a considerable challenge. Even the most thorough preparations will not protect us from unexpected situations, which may affect the quality of the service. The carrier should take them into account when transporting meds:

• failure of the cooling unit or other elements of the cold room
• accident
• theft
• tampering with the goods by third parties
• goods contamination
• failure to satisfy appropriate transport conditions.

In consequence, risk analysis and risk management in transport are key areas. The better the carrier’s procedure are described, the more effectively they are able to minimise effects of an unexpected situation.

What does risk analysis look like in practice?

Our quality team individually evaluates the risk associated with providing the service of transport of medicinal products, basing on the relationship between its probability, detectability, and effect. If the team assesses the risk as moderate or high, risk mitigation measures are implemented. Such an assessment is carried out annually, and if a new type of risk appears, the assessment form is updated accordingly.

Transport of meds in controlled temperature – what is worth checking before selecting the carrier

Pharmaceuticals require special transport conditions; therefore, it is worth making sure whether you entrust your transport to reliable partners. What should you take into consideration?

• GDP certificate – does the carrier have it?
• qualified staff – do the drivers and other personnel involved in transport have relevant trainings and certificates?
• properly equipped vehicles – are refrigerated trucks equipped with required devices and protections?
• do the vehicles have all the required documents – do the vehicles have all certificates, technical inspection reports, and approvals necessary for them to be able to be used in transporting meds?

Pharmaceutical transport in practice

In Eltrans, we strongly support ourselves with technology. We use state-of-the-art telematic solutions every day, in order to constantly control transport temperature. After loading, our forwarders set temperature alarms, and drivers generate control printouts during transport. Transport of meds in controlled temperature is a field in which we are constantly developing. Every year our employees participate in external refresher trainings.

Our quality team works on risk analysis in transport on a current basis. Each possible risk is considered in detail and proper responses and strategies are defined for the purposes of mitigating risky situations. It is very helpful in crisis situations – transport participants know what to do and how to prevent any failures in maintaining temperature conditions.

The Good Distribution Practice we have since 2019 confirms we satisfy the highest standards in pharmaceutical transport.

Transport of meds is our specialty. Would you like to see how we satisfy your expectations concerning the highest requirements of pharmaceutical transport?

Let's write or call to us - we will replay for all your questions:

jakub@eltrans-tsl.pl, Tel. +48 519 756 785.