Three Hurdles in Vaccine distribution
Obstacles in Temperature Controlled Shipping
The pharmaceutical industry has nearly 15 million temperature-sensitive packages moving regularly through cold chain shipping protocols. Cold chain is a temperature-regulated supply chain that keeps temperature-sensitive medical devices and medications safe and effective.
Normally, vaccination campaigns reach around 116 million patients per year, but new light has recently been shed on the importance and details of these distribution channels. TheCOVID-19 vaccinehas created unique challenges in vaccine shipping protocols concerning what exactly is needed to distribute this vaccine quickly and safely. The number of patients needing this vaccine is more extensive than ever before. The vaccine will have to travel the globe, treating patients on every continent. Previous pharmaceutical supply chain efforts can’t come close to supplying the 4.7 to 5.5 billion people with the COVID-19. This challenge is one of themost significant challengesfaced by modern pharma.
However, shipping challenges around medications and vaccines is nothing new. Even before this recent challenge, the World Health Organization (WHO) estimated that more than half of all vaccines in the supply chain go to waste. This is due to temperature-regulation challenges in logistics and shipping.
Read on to learn the steps industry experts recommend for vaccine distribution, cold chain shipping, and quality control.
Table of Contents
Establishing the Right Packaging Solution
Below Zero
Controlled Room Temperature
COLD CHAIN
Due to critical temperature requirements of vaccines, thermal management solutions are critical for cold chain regulation to help
avoid waste. Any temperature misstep with these vaccines could be detrimental.
The first challenge presented to manufacturers is establishing a packaging solution. It must protect and regulate the vaccine for
the entire shipping process.
The pharmaceuticals cold chain can include many touchpoints. Medications and vaccines have various temperature requirements.
From storage and transportation temperatures below zero to cold chain (2°-8°C), or controlled room temperature (20°-25°C), it is critical to provide the correct protection for each shipment.
Transportion Challenges
Transportion Challenges
How can providers keep the medication regulated at each step of the cold chain? It starts with the packaging.
The Food and Drug Administration (FDA) requires packaging to meet and exceed the standards determined during a product’s stability testing. Packaging also must comply with the WHO.
Answering Packaging Development Questions
Packaging development starts with several questions. What is the size of the shipment? What will be the payload of the product? What conditions will the shipment be exposed to? How will requirements change through the shipping process? These are just a few.
Developers consider the distance the product will travel and how to respond to changes in outdoor temperatures, as well. Vaccines get exposed to many temperatures as they are transported from manufacturing to warehouses or distribution centers, and finally, healthcare facilities.
Many vaccines and medications can only withstand a small range of temperature changes and may become unusable after it is exposed to warmer temperatures. This means the temperature must remain stable for the entirety of the shipping and storing process.
Finding the Right Temperature Monitoring Solution for Your Application
- By 2022 the pharmaceutical market is planning to spend $18.8 billion, specifically focusing on temperature-regulation technologies. This will ensure that all vaccines are safely delivered across the world. The industry is getting ready for a boom at each step of the process, from packing to monitoring.
- Once the package selection process is complete, the product undergoes testing. If it is proven to meet the standard, there are still a few other challenges to ensuring the vaccine reaches the healthcare facility safely.
Monitoring is Key
While the right packaging is extremely important, the shipment must be monitored for the entire shipping process. Using an effective monitor is the key to delivering a safe product and creating a standard temperature profile.
By using monitoring technology, the transportation process can be closely watched and tracked to guarantee safe arrival. Implementing these temperature monitoring solutions can provide long-term success and safety for the product’s customers.
The Market: Temperature Monitoring Devices
The right temperature monitoring solution for a pharmaceutical product needs to be effective. It should protect patient safety and guarantee quality. In the event of poor quality control, sickness or reactions may arise. In addition, there is also the impending threat of costly re-vaccination campaigns and product loss.
Like packaging standards, WHO also requires an efficacy standard for international packaging. These include shipping guidelines and require temperature monitoring devices. Temperature indicators and electronic monitoring devices are two types of temperature monitoring devices on the market.
Temperature Indicators
- Temperature indicators use chemical color-changing technology to monitor the temperature. If there is a temperature excursion, the label will indicate a color change, clearly showing the desired range has not been maintained.
- This color change can be monitored in shipment by visual checks or capturing pictures of the product to allow for digital inspection. These images can then be pushed to a cloud solution for review and storage.
- These indicators provide a definitive answer for whether or not a vaccine is safe for a patient to use once it has arrived at its final destination.
Electronic Temperature Data Loggers
Another type of device is an electronic monitoring device. This piece of equipment gathers information throughout the transportation process. It creates a running log of temperature as the shipment takes place.
The temperature record occurs on a scheduled basis, based on how the device is programmed. The information is sent via Bluetooth technology or USB to a platform for visibility by all parties involved. This type of monitoring is extremely accurate and produces a large amount of valuable data.
Stay Connected to Your Product
A break in the lengthy and complicated cold chain for any vaccine could be detrimental. It could leave people vulnerable to viruses and could destroy trust in vaccination efforts.
A crisis could cost providers millions of dollars and create a need for mass re-vaccination. With so many variables, all eyes are on vaccine manufacturers.
This is why visibility and data of supply chain process is more important than ever before. The final step to ensure the medications travel the last mile safely is to connect every step of the way.
A supplier using a monitor can gather and review data to optimize the products
and their supply chain process.
With this data comes the ability to review trends that can streamline the process. These trends can include shipping patterns as well as seasonality challenges.
With monitoring, manufacturers can see the transportation process and ensure products are safe and effective upon arrival; protecting themselves from increased liability and product loss.
Timely corrective decisions for breaks in the supply chain can be made from this valuable data. It keeps manufacturers within the bounds of regulations from the Food and Drug Administration and the World Health Organization.
Keeping Stakeholders Connected
From packaging research to the final delivery of the vaccine, a cloud-base tool provides information every step of the way and keeps all of your stakeholders involved.
Using this technology to store data on the temperature and humidity of products in the shipment allows you to maintain a detailed log of the conditions a product is exposed to during the process.
Access to this data allows companies to easy interpret and analyze the supply chain, ensuring the quality of their product throughout the shipment.
In addition this data can further be analyzed to create action items for all stakeholders;
helping to reduce the risks that can be associated with low-quality cold chains. This allows manufacturers a way to maintain high brand integrity while reducing unnecessary spending.
An ideal solution will provide each stakeholder the data that they need, to make critical decisions concerning the shipment of the product.
Prevent Problems and Waste
- A integrated cloud-based analytics system can help manufacturers see possible issues with a shipment. This provides the ability to address existing cold chain problems and provide specific solutions; dramatically reducing the number of wasted products.
- This means manufacturers can monitor issues instead of reacting to a crisis; signally a tremendous stride forward in providing stability and efficiency in cold chain shipping.
The Last Mile
Even after the COVID-19 vaccine is distributed, there will continue to be a tremendous need globally around temperature controlled vaccine and pharmaceutical shipping.
The temperature monitoring and thermal regulation technologies used to develop these cold chain solutions are vital to send medical products safely through the last mile of the shipping process. ATI leads the way in cold chain and supply chain monitoring and are partnering to create inventive solutions every day.
Contact ATI to request a consultation of your cold chain. Learn how optimization can drive your company forward. Move towards a safer, more effective management process for your products with ATI.
