When it comes to shipping pharmaceuticals, we use cold chain materials to control the temperature of your drugs or medicines from the manufacturer through a delivery to the end user. It’s critical to keep these within the proper temperature range because they can be rendered useless or even harmless if exposed to extreme temperatures.
There are three common temperature ranges we use in the pharmaceutical industry:
- 2-8 °C, or refrigerated
- 20-25 °C, or controlled room temperature
- Below 20 °C, or frozen
However, as simple as this may seem, building a proper supply chain using cold chain technology is actually quite a sophisticated process. There are many factors to consider that often get overlooked which causes a drain on time, money, and resources.
Here are 4 common misconceptions people have about cold chain:
1. “Close Enough” is Fine
Have you ever heard the old adage, “good enough never is?” It applies here! This one comes up a lot and it’s a very common mistake. For example, if you’re shipping a biopharmaceutical product and the label claim says it has to be between 2°C and 8°C, then you need to have documentation per FDA requirements that shows that it's between 2 and 8 throughout its entire journey.
Some people try to say, “Let’s set it for 0°C to 10°C, that’s close enough.” Well, if your label claim is 2 to 8, and you do 0 to 10, then you are setting yourself up for failure and even some heavy fines. One of the things that people don't understand about biopharma in particular is that it's very regulated by the FDA, especially that 2°C to 8°C space. You need to provide proper data logging and reporting that you’re meeting those requirements for the entire journey of that product.
2. It Doesn’t Have to Be So Complicated
What’s the big deal right? Get a styrofoam cooler, throw some frozen ice packs in there and you’re ready to go.
The truth is, cold chain logistics are quite complex and our Research and Development team are constantly running simulations, creating new phase change materials, and solving for new temperature ranges. There are so many factors that go into building an optimal cold chain, including:
- What are you shipping?
- Where are you shipping it?
- How long will it be in transit?
- What is the climate like?
- What temperature range does it need to be kept at?
- What humidity level does it need to meet?
- Can it be exposed to sunlight?
- How many touch points will it have during the journey?
3. You Don’t Need to Worry About Every Touch Point
Speaking of touch points, how many will there be when you’re shipping pharmaceuticals from A to B? This is a hugely important factor that people tend to overlook. Companies know they have to ship it at X temperature across Y miles in Z days. What they don’t consider, however, is that every time the shipment is handled, there is a greatly increased chance for error.
The four most common touch points are:
- Preparing the product for transport to the shipper location
- Transportation to shipper location
- Physical loading
- In transit
The logistics for shipping a high volume of products across great distances means that there will be many opportunities for shipments to be kept out of a refrigeration unit, or left out in the sun, or exposed to water.
This is especially true when you consider that most people handling your shipment won’t be temperature regulation experts. If you have an international package sitting in Customs, for example, they likely don’t have the first clue what to do with it. They might see “temperature sensitive” on the label and stick it in the refrigerator or freezer, which could cause significant damage to the product!
4. All Cold Chain Solutions are Created Equal
The final misconception many people have is thinking that cold chain processes are a commodity and that price is all that matters.
Many businesses forget to consider packaging when they create a new product, so when the time comes to launch it they don’t have any money in their budget. So, they look for the cheapest solution on the market.
Don’t let this be you!
Packaging is such a critical component of your product plan and when it gets overlooked, there’s so much that suffers. At best, you will often waste lots of time, money, and energy dealing with the fallout of shipping products in subpar packaging, having to reship, restock, and deal with upset customers. At worst, if your product falls out of the proper temperature range, it could be rendered dangerous and harmful to its end user.