Preventing temperature excursions in pharmaceuticals

Keeping medicines and vaccines safe during transportation can be a huge challenge for supply chain managers and pharmaceutical companies. When a temperature sensitive medicine or vaccine becomes too hot or cold, it may lose its potency or become unsafe for patients. These risks make temperature excursions in transporting pharmaceuticals through the supply chain a major concern in pharmaceutical quality and logistics.

Here's an overview of why temperature excursions happen and the best products and tools to help you keep medicines safe across the supply chain journey.

What is a pharmaceutical temperature excursion?

A temperature excursion in pharmaceuticals means a drug, vaccine, or other product is stored, handled, or transported outside its safe time and temperature range. This can happen during storage and transportation, such as in a warehouse, truck, ship, on the airplane tarmac waiting to be loaded, or when it's being delivered to a clinic. When a temperature excursion occurs, the product can become unfit for patient use.

Stability testing and data from the manufacturer explains what amount of time and what temperature ranges are unacceptable for each medicine or vaccine, for both storage and shipping. If a temperature sensitive product goes out of this range for too long, the shipment will potentially have to be discarded and resupplied in order to protect patients.

Why are temperature excursions a big problem?

Temperature excursions in pharmaceuticals can lead to many problems:

• Drug shortages: If a shipment is temperature abused, there may not be enough medicine for patients due to stock outs.
• Wasted money: Compromised medicines have to be replaced, which can be costly.
• Regulatory challenges: Companies must follow strict compliance rules. If storage conditions are not met, there can be massive fines and penalties.
• Delayed care: Patients may not get the medicine they need on time.

Why do pharmaceutical shipping temperature excursions happen?

There are many reasons for pharmaceutical shipping temperature excursions, including:

• Environmental conditions: Very hot or cold weather can make it hard to keep the correct temperature during storage, handling, and transportation.
• Human error: People can leave part of a shipment on the airport tarmac for too long, set the wrong temperature in a refrigerated truck, misplace a set of boxes in a temporary warehouse, or skip a step in the process.
• Equipment failure: Fridges or freezers can breakdown at a hospital while a shipment is on the way.
• Delays: A shipment can be exposed to temperatures outside the safe range wstuck at customs, at the border, or during bad weather
• Freeze thaw cycles: Some medicines are damaged by being frozen and then thawed again.
• Storage mistakes: Putting a temperature sensitive product in the wrong place can degrade it.

Even with the best planning, a temperature excursion event can still happen. That is why monitoring and quick interventions are so important.

What to do if a temperature excursion occurs

When a temperature excursion occurs, it is important to follow your company’s standard operating procedures:

1. At delivery, check the temperature data from your data loggers and upload the data to the system or while the shipment is on its journey. Check the IoT device data in the monitoring system which automatically uploads the data.
2. Quality looks at the excursion and the stability data for the product to determine if it is still safe to use and if it can be delivered to the next step of its journey.
3. Review the storage conditions during the excursion event if it occurred in a cold room, freezer, or refrigerator. Quality would determine if the product was exposed to temperatures outside the allowable range for too long of a time.
4. Quality will decide if the product can be saved or must be discarded. At the final pharmacy, the pharmacist will decide if the medicine can be accepted or returned at delivery.
5. Document everything. The datalogger or IoT device will capture when the temperature excursion occurred and for how long with properly programmed alarms. Quality will determine what caused it and what actions to take in the future to prevent it from occurring again.

Handling pharmaceutical temperature excursions quickly, while following proper procedures, helps protect patients and keeps your company in compliance.

How to prevent pharmaceutical shipping temperature excursions

Preventing pharmaceutical temperature excursions is better than fixing problems after they happen. To aid in this effort, everyone who handles medicines should know how to avoid human error and what to do if a temperature excursion event happens.

Planning for environmental conditions and other supply chain disruptions is also key. Shippers should use designated proper insulated packaging, refrigerated or dry trucks, and qualified cold chain logistics partners. These resources aid in keeping temperature sensitive product shipments safe from extreme temperatures.

Additionally, shippers must always follow the correct storage conditions and standard operating procedures. When a temperature monitoring system shows a problem, they should act right away to move the shipment or fix the issue.

Finally, shippers must regularly check for weak spots in their storage and transportation process and update their procedures to reduce risk. Analyzing the temperature excursion data across many shipments in an oversight system helps shippers identify where the weak spots are in their supply chain and supports investigation and corrective actions.

Pharmaceutical shipping temperature excursions: available products and solutions

There are many pharmaceutical services and supply chain support products to help keep medicines safe. For example, data loggers and IoT devices travel with the shipment and record the temperature every few minutes. If the temperature goes outside the safe range, the IoT device will show exactly when and where the temperature excursion occurred. Some devices with intelligent software can even send real-time alerts so your partners can act fast and intervene.

Real-time temperature devices can also track the temperature range in real time and send alerts if there is a problem such as a delay or a missed flight. Additionally, cloud-based temperature monitoring oversight platforms let logistics managers see shipments anywhere in the world and act with their partners on critical drug shipments.

Many companies invest in high quality cold chain logistics services, which include temperature-controlled trucks and storage for temperature sensitive pharmaceuticals. They also invest in and qualify thermal and active packaging, which can help keep products at the right temperature, even if there are delays.

Temperature monitoring oversight and intelligence providers like Overhaul make temperature monitoring even easier. Overhaul’s software platform supports any data loggers and IoT devices, lowering your risk with a device agnostic provider. This gives logistics managers real-time access to temperature data with locations for each shipment.

If a shipment of pharmaceuticals has a temperature excursion, Overhaul’s system automatically sends instant alerts so logistics teams can act quickly to protect product integrity. In turn the quality department will be able to act more quickly by beginning its temperature assessment and storing the data to meet compliance requirements. Additional risk reduction can be employed utilizing Overhaul’s control tower, with watch officers for critical shipments that need close temperature monitoring and interventions.

By partnering with an experienced oversight visibility and intelligence SaaS provider, companies can better manage their transportation network and shipping conditions for temperature sensitive pharmaceuticals and reduce the risk of excursion events.

Why investing in temperature excursion pharmaceutical solutions matters

Pharmaceuticals can be high in value and may offer life-saving treatments. Even one temperature excursion can mean costly delays, wasted product, and risk for patients. Using good temperature monitoring tools, reliable temperature monitoring devices, and strong standard operating procedures protects your medicines from extreme environmental conditions, human error, and equipment failure.

Every part of the supply chain, from pharmaceutical manufacturing to delivery, must focus on preventing temperature excursions. By investing in the right technology and training, you can keep temperature sensitive pharmaceuticals safe and avoid costly problems.

In the end, keeping temperature sensitive pharmaceuticals safe is about more than following rules. It’s about making sure every patient gets safe, effective medicine, every time.

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