Temperature maintenance is one hot topic that is critical to ensure your clinical trial is successful and your supply needs are met. It is no surprise that temperature excursions have a significant impact on the clinical supply process. Temperature excursions occur when materials needed in clinical trials are stored at a temperature outside of the specified range as defined on the label. Workers on site are then responsible for the documentation of the storage condition on a temperature record. Consequently, the predominant impact an excursion can have is on the quality of the drug itself, which not only will cause severe delays for patients when receiving the drug, but it can also have huge ramifications on patient safety.
The inherent dangers of temperature excursions are simple enough; they can stop drugs from working as they should, which could potentially render whole batches unusable and would therefore need to be destroyed. One of the main challenges you have with maintaining this issue is ensuring you have the right personnel at each stage of the supply chain, from the manufacturers to the initial end stage of the supply process. Therefore, it is essential the personnel involved in this process are specialists.
It is also important to note that different investigational products that are a specific temperature and generally have fewer specifications might not have the required permits, so you could be shipping to a region that has strict specifications. Also, if you are working through a courier like DHL and are using containers to control the temperature, be advised that while there are shipping technologies available they are very expensive to use.
For shipping technologies such as mini refrigerators that require a customs agent, you can use an insulated box or a temperature controlled device you can plug into a wall. This is important as there are strict rules on temperature ranges that products can stay between, so you have to track the temperature throughout the course of the shipment. If it goes out of range, quality issues can crop up. For example, GSK have now started to implement continuous temperature monitoring of all their shipments. There are also electronic temperature monitors that various companies adopt, such as TempTale, which electronically checks the temperature of a shipment and provides you with a recorded history. Additionally, it is important to note that temperature monitors can provide GPS locations, enabling you to track the shipment as well as its temperature throughout its journey.
A word on Cryogenic Temperatures
Cryogenic temperatures preserve and store materials below 100 degrees, yet nobody has the capacity to store materials in such temperatures. For cell therapy products, which need to be preserved in cryogenic temperatures for shipments and storage, the infrastructure is very important. However, it does not necessarily exist as it hasn’t been developed yet. This is because nobody stores their APIs in that temperature range because the molecules are stable at 228 degrees.
This is an important consideration because the extent to which cryogenic temperatures could affect the shipping of products really depends on how much it needs to be frozen. The knock on effect this could have could influence how you ship your supplies. The implications could cause severe delays and would heavily impact the quality of the product, ultimately endangering your clinical trial.