HealthCold Chain Logistics and Storage for Pharmaceuticals

Cold Chain Logistics and Storage for Pharmaceuticals

Creating reliable, secure, and efficient supply chains is crucial in many different industries. However, when the cargo being shipped to consumers has the power to save lives, the importance of supply chain management takes on a totally new meaning. Such is the case for the pharmaceutical industry because supply chain failures can actually cost people their lives.

The COVID-19 pandemic has cast the importance of supply chains into the spotlight, highlighting the need for supply chains that hospitals and healthcare facilities can rely on. The pandemic unfortunately also shook many people’s confidence about the integrity of supply chains that ship life-supporting goods, including food and medical products. Luckily, many pharmaceutical companies are taking steps to shore up their supply chain practices and ensure that quality assurance standards are met.

One of the most important aspects of pharmaceutical supply chains is to make sure that medical products are kept in safe storage conditions. Storage facilities must be secured, inspected, cleaned, and maintained. Failures in pharmaceutical supply chain management can result in delayed shipments of medical products and tragic consequences. 

Since cold storage for pharmaceuticals is so important and often misunderstood, let’s explore some of the main points companies must keep in mind when setting up supply chains in the time of COVID-19.

Cold Chain Storage for Pharmaceuticals

One of the most challenging and important parts of setting up reliable supply chains for pharmaceutical products is considering the storage conditions necessary for different medical products. Many medicines must be stored at particular temperature ranges. As a result, cooling facilities such as refrigerators, refrigerated trucks, or freezers are necessary to keep medical products safe and effective.

The practice of creating, maintaining, and managing temperature-controlled supply chains is known as cold chain storage. Cold chain storage is crucial not just for the pharmaceutical industry but also for many other life-supporting sectors of the economy including the agricultural industry.

Some medical products, such as the Pfizer COVID-19 vaccine, must be stored at ultra-low temperatures in order to remain effective. The Pfizer vaccine should ideally be kept at -70 degrees Celsius to prolong the amount of time it can be stored before expiring. That is well below the temperature that most commercial freezers can reach, which is why specialized shipping containers and ultra-low temperature freezers are needed.

Data Loggers and Cold Chain Storage

According to Dickson&Data, to establish and maintain cold storage for pharmaceuticals, companies make use of a variety of technologies. Perhaps the most important tool to uphold the reliability of cold chain storage systems is data loggers.  Data loggers are small, electronic devices that collect environmental data such as temperature, differential pressure, and humidity from their surroundings. 

This data can be stored in the data logger’s on-board memory and later transferred to an external computer, hard drive, software system, or the cloud. This allows managers to get an accurate view of the temperatures of each of their storage units which house temperature-sensitive pharmaceutical products. If storage facility temperatures deviate from expected ranges, managers can act quickly to correct any equipment malfunctions or other problems that endanger the company’s products. 

Many pharmaceutical products can become unstable or ineffective if exposed to inappropriate storage temperatures and, since so many patients rely on these medications, getting storage conditions right can literally be a life or death issue. That’s why regulatory agencies place a strong emphasis on monitoring the temperatures of pharmaceutical storage facilities. 

In fact, pharmaceutical companies that handle temperature-sensitive products must format and submit the temperature data of storage facilities on a regular basis. To do so, companies rely on powerful software that analyzes temperature data for anomalous patterns and then formats that data so it can be passed on to regulators. 

Maintaining and submitting accurate temperature logs is a crucial part of many companies’ compliance departments. Failure to do so will make them run afoul of powerful regulatory agencies such as the US Food and Drug Administration, and the EU’s Good Distribution Practice of Medicinal Products for Human Use (GDP.)

Cloud Storage and Real-Time Temperature Monitoring

Many pharmaceutical companies are integrating more modern or innovative procedures to collect and record temperature data. Many of these new approaches allow pharmaceutical companies to view and monitor storage temperatures in real-time, rather than reviewing temperature data after it is stored on a data logger and transferred to a computer.

For example, internet-connected data loggers can send real-time temperature data to connected computers over the internet. This allows managers the ability to immediately detect if a deviation in temperatures has occurred and prevent costly factory mixups

Similarly, Bluetooth-enabled data loggers can transmit data to a Bluetooth bridge device, and then to external computer systems. 

Pharmaceutical companies that integrate Bluetooth or internet-connected data loggers must practice careful cybersecurity procedures. Despite some cybersecurity risks, real-time temperature monitoring gives managers the ability to limit waste, bolster quality assurance procedures, and improve accessibility

Often, pharmaceutical companies make use of cloud storage technology when introducing real-time temperature monitoring procedures. This means that rather than maintaining their own in-house hard drives and IT infrastructure, they can effectively rent this infrastructure from a third-party provider. The third party secures and backs up this data to maintain clear and accurate temperature records.

Popular cloud storage providers include Amazon Web Services, Google Cloud Platform, and Microsoft Cloud. When working with a cloud storage provider, temperature data is sent to a cloud storage platform over the internet. Data stored in the cloud can then be analyzed, formatted, and submitted to regulators, all without a pharmaceutical company having to store it on its own internal systems. 

Despite its potential to save money and limit technical difficulties, pharmaceutical companies must take into account the data privacy and cybersecurity concerns that come with working with a cloud storage provider. 

To sum up, we’ve seen how cold storage for pharmaceuticals is a complex and multifaceted process.  To create and maintain cold chain storage systems while following regulatory guidelines, pharmaceutical companies make use of a variety of tools and practices including data loggers, refrigeration systems, and cloud storage infrastructure. 

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