The correct handling and proper transport of temperature sensitive products is becoming more important not because of strict regulations, but because of the need to ensure the integrity of the products and the cold chain. After all, regulations are becoming stricter and more detailed because we now better understand the risks and hazards from compromised products.
It’s especially the case in handling and transporting biological medicines. These are temperature-sensitive products that are susceptible to degradation if not stored and transported under controlled conditions. Deviations from approved storage conditions (especially temperature deviations) can affect not just the shelf life of the biological medicines, but also their effectiveness, integrity and overall safety.
The complex requirements of biological products
Many biological products are composed of proteins, nucleic acids, sugars and combinations of these substances (and sometimes entire cells and tissues). These are produced through advanced biotechnology methods under strictly controlled conditions.
The conditions are also strict and detailed when it comes to handling, storing and transporting biological products. Heat and temperature deviations (especially huge deviations or exposure to such deviations in long periods) can compromise those products. It’s similar to how heat changes the biochemical composition of eggs. Because of heat, the native state of the chains of amino acids drastically change (i.e. the protein gets denatured). The bonds that hold the molecules into shape get disrupted and as a result, the proteins clump together and solidify (which then makes the egg white and yolk to harden).
Structure often dictates the ultimate function of a molecule or biological entity. Change the structure and the function will follow suit. In biological medicines though, if the structure was changed (due to temperature deviations and microbial contamination as well) the products would become useless or even harmful. Temperature deviations can significantly or drastically change the structures of biological products and might even speed up certain enzymatic activities that lead to degradation. That degradation and the by-products might be harmful to the end users.
Biological products and entities are plain sensitive to temperature deviations. They are made to endure only a narrow temperature range (“the safe zone”) and significant changes can occur if the products and entities were exposed outside that safe zone for a significant amount of time. It’s similar to how we humans respond to heat and cold. We immediately feel uncomfortable whenever we’re outside our safe zone (e.g. 5℃ above or below what we’re used to). Good thing is we can easily adapt or bring back ourselves to comfort by taking a shower, wearing an additional layer of clothing or turning on the AC. We can retain our basic functions and remain productive throughout the day just by making some adjustments.
It’s different though if we’re talking about temperature-sensitive products. Whether during transport or storage, there are actually a lot of things that can happen. For instance, deviation from the approved storage conditions can make the quality of the products unacceptable and unsuitable for supply. Biologic medicines are often temperature-sensitive, usually stored refrigerated and might become unstable in a very unpredictable manner.
How to maintain and ensure integrity
As a result, it’s important to ensure tight temperature control and that the safe zone is being maintained at all times during transit and storage. This way, the integrity of the cold chain and the products will be maintained at an acceptable level and quality.
However, this is a challenge because we don’t know exactly what happens during transit and storage. Although the documentation says that temperature levels were maintained at ±0.5℃, we really don’t know for sure and the temperature deviations won’t actually manifest instantly. That’s because the biologic medicines and other temperature-sensitive products might look normal and all right. The effects and compromise will only be apparent if someone was already using them. The effects could be catastrophic because human lives are at stake here.
What can we do then? It’s helpful to use temperature recorders and indicators in such cases. These can show you if the products were compromised in terms of temperature deviations. For example, a single-use temperature indicator can tell you if the shipment has been compromised. You can also choose a temperature recorder that captures the data every minute. This way you can know if the shipment has been compromised plus the information on how long it happened.
It’s like having a third-party auditor or inspector you can rely on to verify the accuracy of information you’re getting. The supplier or personnel in charge of the shipment might do their best to ensure the integrity of delivery and the information being presented. However, errors are sometimes inevitable and there are also uncertainties about what happens during transit and storage. But with a temperature indicator or recorder, you have an additional layer of verification and accuracy not just for your peace of mind, but also for ensuring the integrity of the shipment.
This is especially important in transporting blood bags, seafood and other food products (whether raw or prepared). For example, red blood cell products (e.g. transport temperature range of 2 to 10℃) should not be exposed to temperature levels outside refrigeration specifications for more than 30 minutes and when the frozen blood products are taken out of the storage conditions, the products should be kept on frozen ballast or dry ice within a container. Temperature deviations can accelerate biochemical, microbial and enzymatic activities which could then lead to the production of toxins and making the entire produce unfit for use.
Here at ShockWatch we have temperature recorders and single-use temperature indicators with a 0.5 to 2℃ accuracy. Our temperature monitoring devices can be useful in temperature conditions ranging from -80°C to +37°C. We also have specific indicators that comply with the latest regulations on shipments. Many of our clients have used our indicators and recorders for their temperature-sensitive products (biologics, food products, seafood, meat, dairy).
Contact us today for specific solutions so you can better ensure the integrity of your shipment. We even meet special requirements such as if the products have to be in -80°C, being submerged in water and other extreme environments.