When Quality Never Stops: How We Protect Every Shipment, Every Time

Protecting the integrity of drugs and other pharmaceutical products is one of the foremost priorities of a biopharma logistics company. There are countless environmental factors that can impact a drug’s viability, from temperature to humidity and even the orientation of a container. Being certain that products are being stored and shipped in ideal, Good Manufacturing Practice conditions is critical for safety, efficacy, and compliance alike, leaving no room for errors or excursions.

As a result, a trustworthy organization handling these products will take thorough measures to ensure these products are kept in a suitable environment at all times. Here, we explore some of the considerations and methods for protecting these conditions, such as auditing storage premises, qualifying transportation equipment, and utilizing real-time data loggers that can monitor a variety of critical conditions.

Critical controls for safe and compliant storage

Ensuring an ideal environment starts at the storage facility, long before medicinal products are shipped to their final destinations. There, conditions such as temperature and humidity should be constantly monitored to ensure they fall within an acceptable window. Further, measures should be taken to maintain that window — for instance, establishing backup power to keep freezers and refrigerators running in the event of an outage.

Storage facility managers should also be aware of the risk of contaminants in the facility. As one example, cardboard, in which many common items are transported, can often be a vessel for spreading microbes, such as mold, yeast, and other fungi. Once introduced to an area, these microbes can spread and take root in any number of places, potentially exposing stored drugs or their packaging to harmful organisms. Storage facilities should institute consistent, thorough cleaning procedures to prevent the growth of such contaminants. Additionally, a dedicated partner will regularly take swabs from around the facility to test for the presence of contaminants, and take action to mitigate them if found.

Qualifying transportation equipment

When transporting temperature-controlled products, it is critical to fully assess and characterize the abilities of the associated equipment. Data loggers, for example, should be regularly calibrated to ensure accuracy and consistency. Additionally, vehicles should be temperature mapped, which involves using sensors throughout an area to record temperatures over a period of time, enabling the identification of any areas with abnormalities that might impact products.

Similarly, shippers — portable containers insulated for precise temperature control — should undergo qualification, or testing, to ensure they can maintain the required temperatures for a given amount of time. It is particularly important to test their capabilities across the full range of extreme external environments, from very hot to very cold, in real-world shipping conditions. This allows logistics providers to be certain of the impact of outside conditions on any sensitive items they may be transporting, as well as providing confidence that the shippers meet the necessary specifications.

Utilizing real-time data loggers

Data loggers are a critical tool in ensuring the maintenance of the proper conditions. While loggers are frequently used to monitor the temperature of a product being shipped, they can also be used to track other key environmental factors, such as light and humidity. Additionally, comparable sensors may be used in static storage, rather than just in transit. This provides a record of the conditions of a product over time, critical information for ensuring the safety and viability of environmentally sensitive drugs.

Real-time monitoring, in particular, is an invaluable logger capability for ensuring drugs and medicinal products are consistently kept in the proper conditions. Such monitoring can send regular status alerts to key personnel, and may even enable alarms when an excursion threshold is crossed. By providing this information in real time, monitoring enables the appropriate mitigation actions to be taken as soon as possible, and, as a result, minimizes the negative impact of any undesirable fluctuations.

An ongoing commitment to quality

Maintaining satisfactory conditions for biopharmaceutical products is an ongoing task that requires constant vigilance on the part of a logistics provider. Every shipment is important, meaning that every step of the process must be handled with care. Partnering with a trustworthy logistics provider, such as Yourway, that goes above and beyond to ensure a high-quality storage and transportation environment, is one of the most important things a trial sponsor or drug manufacturer can do to protect its products’ integrity.