Temperature excursions jeopardize a drug’s efficacy and pose serious health risks to patients and financial repercussions for pharmaceutical companies. Discover how to ensure do-not-freeze injectable drug stability during last mile distribution.
Key Takeaways:
- Maintaining proper temperature conditions of do-not-freeze injectable drugs during last mile distribution is essential.
- Temperature excursions cause financial losses at best and harm to patients at worst.
- Temperature indicators and data loggers make determining whether freezing occurred during transit easier.
- Adhering to regulatory and industry best practices is essential in cold chain management.
Precision and reliability are paramount in the pharmaceutical industry. Every production aspect must be meticulously controlled to ensure the efficacy and safety of medications and vaccines. This level of control extends to distribution, where cold chain logistics are crucial to maintaining the integrity of products.
Do-not-freeze injectable drugs, including biologics (such as insulin) and GLP-1 class drugs, must be transported and stored under the right conditions to maintain their potency and quality. However, determining whether unacceptably low temperatures occurred during transit can be challenging, as freezing isn’t always evident. Continuous monitoring is needed to comply with regulations, detect temperature deviations, take corrective measures, and deliver safe products.
In this article, we discuss the high-stakes implications of temperature excursions on do-not-freeze injectable drugs. You’ll also learn about the best strategies and tools to maintain these drugs’ integrity in the last mile of distribution. Let’s dive in.
Quality Impact of Temperature Deviations of Do-not-freeze Injectable Drugs
When do-not-freeze injectable drugs are exposed to temperatures outside the range prescribed for storage and transport, their chemical and physical properties become altered. At this point, the drugs are less effective and potentially harmful to patients and must be discarded.
Even the slightest temperature variation in the last mile of distribution can wreak havoc, spoiling entire batches of medicine. As you can imagine, such events create significant financial losses for pharmaceutical companies – The Institute for Human Data Science (IQVIA) estimates the biopharma industry loses about $35 billion annually due to cold chain logistics and temperature control issues.
The good news is that these losses are avoidable, provided you become more agile and adapt digital technologies for supply chain control and visibility.
Modern Temperature Monitoring Makes Last Mile Distribution Less Daunting
Ensuring every batch of do-not-freeze injectable drugs is safe and high-quality doesn’t have to be daunting. Continuous monitoring lets you catch temperature excursions early and mitigate them before they become problematic.
You can track temperature fluctuations using two modern technologies:
-Temperature indicators: These cost-effective stickers change color to alert you when do-not-freeze injectable drugs are exposed to potentially damaging temperature levels. For example, FreezeSafe indicators turn from clear to magenta when temperatures fall below the prescribed threshold. That way, you’ll know whether the drug has frozen and thawed during transit even when it has no visible signs of having frozen.
–Condition monitors: These cutting-edge devices continuously measure critical environmental profiles of pharmaceuticals and provide a full view of their journey through the supply chain.
For example, the MaxiLog Alert condition monitors can provide precise temperature tracing with easy data retrieval via a built-in USB interface and instant alerts (red LED flashes) when unfavorable temperature decreases occur.
You can set a custom start time delay and data sampling interval of 2 seconds to 36 hours, allowing the monitor to adjust to the shipment’s internal temperatures and capture data as often as needed.
Plus, they can store up to 8,070 data points, have a three-year or one-year battery operating life, and are ultra-compact, making them the ideal companion during the distribution of do-not-freeze injectable drugs.
Techniques for Temperature Stability During Transportation and Storage
Real-time temperature monitoring and evaluation ensures that do-not-freeze injectable drugs are within the proper range in the last mile of their journey, which is essential. Deviations must be reported and inspected immediately when they occur.
Cold chain logistics managers must use the right solutions for the product being shipped at every stage of the supply chain. Single-use indicators are most valuable during the last mile since they are more easily read by distribution staff and end users. On the other hand, devices with minute-by-minute connected alerts and robust analytics capabilities are preferable for continuously monitoring the entire supply chain.
In addition, everyone involved in the last mile distribution should understand their job and its far-reaching consequences. This can be achieved through regular, comprehensive training programs that cover the procedures for handling temperature-sensitive drugs, and the procedures to follow when there is an alert of a temperature excursion.
The training should be tailored to each personnel’s role and give them a thorough understanding of temperature control best practices and the effect of excursions on drug quality and safety. Evaluation should be done at the end of the training to guarantee adequate learning.
There should also be an effort to keep workers updated with relevant regulation compliance and industry standards.
The regulatory Landscape Governing the Distribution of Pharmaceuticals
Maintaining a secure and safe cold chain is critical to the safety of pharmaceutical supply. For this reason, the distribution of healthcare-related products is highly regulated.
As temperature-sensitive drugs increase, there’s a shift toward standardizing pharmaceutical distribution regulation. In the United States, the Food and Drug Administration (FDA) outlines its standards for distributing healthcare-related products in the Current Good Manufacturing Practices (CGMP). The document stipulates best practices for transport, packaging, labeling, record-keeping, and personnel training.
Similarly, the EU’s Good Distribution Practice of Medicinal Products for Human Use (GDP) requires cold chain logistics stakeholders to ensure the integrity and quality of medicinal products by adhering to the storage conditions prescribed by manufacturers.
Understanding the regulatory and logistical requirements for do-not-freeze injectable drugs and implementing cold chain management best practices in the last mile helps prevent product degradation, ensuring products reach end-users safely.
How SpotSee Supports Last Mile Distribution of Do-Not-Freeze Injectable Drugs
There’s no doubt that keeping do-not-freeze injectable drugs stable from manufacturing to the last mile of their journey is essential. Doing so protects end users from harm and eliminates financial losses that may arise from waste and lawsuits. Consider Supply Chain Monitoring from experts at SpotSee.
Modern temperature monitoring devices such as SpotSee’s FreezeSafe single-use indicators and MaxiLog Alert temperature data loggers, among others, make monitoring deviations less daunting. Combined with the right techniques and employee training, these tools ensure success in last mile distribution.
SpotSee’s FreezeSafe product line provides an edge in cold chain logistics. Feel free to get in touch with our team if you have any questions, and start your quality distribution today.
