by The COVID-19 global pandemic and ensuing policy responses have sparked a worldwide fascination with new vaccine platforms and pharmaceutical products. However, developing COVID-19 vaccines and treatments has presented several logistics and supply chain challenges for pharmaceutical companies.
Most major COVID-19 vaccines require storage at low or ultra-low temperatures to remain chemically stable and clinically effective. This mandate represents a significant challenge when transporting vaccines to healthcare facilities and storing them before administration to patients.
The Pfizer COVID-19 vaccine, for example, is particularly sensitive to temperature changes and is typically stored in the extremely low-temperature range of -70 degrees Celsius. Therefore, a low range for storage containers that use dry ice when shipping these vaccines to healthcare facilities.
Technically, messenger RNA or mRNA technology establishes Pfizer’s vaccine storage temperature between -90 and -60 degrees Celsius to maximize its longevity. In addition, storage in freezers is possible for a short period at a temperature between -25 and -15 degrees Celsius. However, the vaccine will expire after being stored in a freezer at this temperature for just two weeks if not returned to ultra-low temperatures.
Similarly, the Pfizer COVID-19 vaccine can also be refrigerated for short periods at temperatures between 2 and 8 degrees Celsius, but it expires after being refrigerated for 31 days. Healthcare workers must also consider that the vaccine can be returned to ultra-low storage temperatures just one time after keeping it in the freezer. They must also acknowledge that all these storage guidelines apply only to vaccines before mixing with a dilutant, which is necessary before administration.
Similarly to Pfizer’s vaccine, other COVID-19 vaccines, most developed on an adenovirus viral vector platform, have storage requirements. Generally, however, these vaccines have less exotic temperature requirements and can be refrigerated and transported at temperatures between 2 and 8 degrees Celsius.
Cold Data Storage for Vaccines and Pharmaceuticals
After considering the specific storage requirements for COVID-19 vaccines, it quickly became apparent to establish systems and procedures to ensure safe storage conditions for vaccines during shipment to healthcare facilities. As a result, pharmaceutical companies must contend with the formidable supply chain and logistics challenges entailed in getting products to consumers and setting up and monitoring cold storage conditions.
The challenge of creating, maintaining, and monitoring temperature-controlled supply chains exists in pharma and other sectors such as agriculture, known in the industry as cold chain storage. Aside from establishing cooling systems for all storage facilities, companies must also employ tools that monitor temperatures in those facilities so that management will know if any products become exposed to inappropriate temperatures.
This development is crucial not only for quality assurance purposes but also for compliance. That’s because regulators require companies to submit temperature storage data to protect consumers and patients.
In addition, temperature data must be gathered at consistent time intervals and formatted correctly before submission to regulatory agencies. Finally, cold chain storage has come into the spotlight recently due to the uncertainty surrounding supply chains essential to the global economy.
Data Loggers for Cold Chain Storage
Pharmaceutical companies use various tools, including data loggers, to collect and record accurate temperature data from storage facilities for quality assurance and compliance. Data loggers are small electronic devices that collect environmental data such as temperature, humidity, and differential pressure. In addition, storage facilities may install data loggers to measure and record ambient temperatures at regular intervals.
This data can then be stored on the device’s internal memory and later transferred to computer systems. The data can then be analyzed using software that alerts managers to patterns and inconsistencies. In addition, some data analysis software uses powerful machine learning and AI algorithms to rapidly parse data and detect any potential irregularities.
The software can format the data appropriately for regulatory approval. Pharmaceutical companies must keep organized records of all cold storage data they collect to avoid any future legal liability for ineffective products.
According to Dickson Data, Cold data storage is also crucial for meeting traceability requirements. Traceability is vital because pharmaceutical companies can track products throughout each phase of the supply chain. For example, if a batch of products is ineffective or contaminated, they can determine which storage facility is to blame. It also enables companies to execute necessary product recalls.
Types of Data Loggers Used for Cold Chain Storage
Over the years, new models of data loggers have come to market that offers pharmaceutical companies additional benefits when it comes to cold data storage. For example, internet-connected data loggers can transmit data to external computers or IT systems remotely and wirelessly. That cuts labor costs and increases the bandwidth for data sent and analyzed.
Internet-connected data loggers also allow management to identify oversights or errors in the cold chain process quickly. For example, some of these data loggers can become programmed to automatically send an alert to management if temperatures within a particular storage unit exceed certain thresholds. This notification allows supply chain professionals to move quickly and identify cold storage problems.
Internet-enabled data loggers also allow companies to leverage modern cloud storage solutions, which simplify storing, organizing, and analyzing large data sets. Cloud storage platforms can also increase the shareability and accessibility of cold storage data. Rather than accessing the company’s internal IT infrastructure, qualified individuals can receive permission to view or share that data online.
Internet-enabled data loggers present some drawbacks in cybersecurity risks that companies must consider. However, for companies that take steps to ensure data security, the benefits of connected cold storage data to the internet are profound.
To wrap up, it’s clear that cold data storage is a crucial part of storing and transporting COVID-19 vaccines. However, cold chain storage is a costly, intricate process that pharmaceutical companies must plan..
