According to a recent report published by Grand View Research, the global pharmaceutical cold chain packaging market size was estimated at $15.18 billion in 2023 and is projected to grow at a CAGR of 14.8% from 2024 to 2030 driven by increasing demand for temperature-sensitive products such as biologics, vaccines, and certain drug formulations and the growing vaccine market across the world.

The demand for temperature-sensitive medications underscores the necessity for reliable cold chain logistics for avoiding temperature excursions.

What is a Temperature Excursion?

The CDC defines a temperature excursion as “any temperature reading that is outside the recommended range for storage as defined in the manufacturer’s package insert.” Avoiding temperature excursions is paramount because temperature-sensitive medications can quickly degrade or lose effectiveness if not maintained at optimal temperatures.

In this exclusive interview with Contract Pharma, David Webber, Senior Global Marketing Manager, Reusable Solutions & Services, Cold Chain Technologies (CCT), shares his insights on temperature excursions—from their causes and consequences to recent advancements in technology, regulatory compliance and best practices.

Contract Pharma: What is the difference between a temperature excursion and a deviation?

David Webber: A temperature excursion occurs when a pharmaceutical product is exposed to temperatures outside of its approved range for a specific period, potentially impacting its stability and effectiveness. A deviation is any measurable difference between an observed value and an expected or “normal” value for a process or product condition, or a departure from a documented standard, procedure or regulatory requirement.

While a temperature excursion is a type of deviation, not all deviations must involve temperature issues—they can also include mishandling, documentation errors or incorrect packaging.

CP: What are the most common causes of temperature excursions in pharmaceutical supply chains, and how can companies mitigate these risks?

DW: Temperature excursions in pharmaceutical supply chains can be caused by inadequate packaging, transit delays, exposure to extreme weather and human error in handling. If a shipment is not packed properly with sufficient thermal protection, it becomes vulnerable to external temperature fluctuations, especially when exposed to unexpected delays or drastic weather changes.

To mitigate these risks, pharmaceutical and life science companies must invest in validated, high-performance temperature-controlled packaging that maintains product integrity regardless of external conditions.

In addition to reliable packaging, real-time monitoring solutions play a crucial role in ensuring product safety. Data loggers attached to shipments continuously track internal temperatures and automatically send data to the cloud. If an excursion occurs, the system sends instant notifications, allowing for quick intervention.

CP: What consequences can an excursion have on a product’s quality?

DW: A temperature excursion can have very significant consequences when transporting pharmaceutical products, potentially leading to reduced efficacy, degradation, or complete loss of the product. Biologics, vaccines, and cell and gene therapies are particularly sensitive to temperature fluctuations and even brief exposure outside the required range can make them unsafe for patient use.

Beyond product integrity, excursions can result in financial loss, regulatory non-compliance, and reputational damage. In the worst cases, they can lead to costly recalls or, more critically, serious risks to patient safety. Preventing excursions with properly validated packaging and real-time monitoring is essential to maintaining the quality and reliability of life-saving medicines.

CP: How have advancements in data logging, real-time monitoring, and IoT technologies improved temperature control and excursion management in recent years?

DW: The evolution of real-time monitoring and IoT technologies over the years has significantly improved temperature control in pharmaceutical logistics. Traditional manual logging is no longer sufficient, as modern digital solutions now allow for continuous, automated tracking of shipments.

For example, CCT’s data loggers automatically record and transmit temperature data to the cloud, enabling proactive detection of fluctuations and early warning alerts. Meanwhile, the Smart Solutions platform provides centralized shipment management, including route planning, real-time tracking, and predictive analytics.

CP: What strategies should pharma companies implement to ensure proper documentation and decision-making when a temperature excursion occurs?

DW: The best approach to managing temperature excursions is to prevent them from happening in the first place. Proactive monitoring and predictive analytics play a crucial role in identifying potential risks before they lead to an excursion. By leveraging real-time modelling and automated data logging, pharma and life sciences companies can anticipate issues, take corrective action in advance, and reduce the likelihood of product loss.

However, when an excursion does occur, having a structured process for documentation and decision-making is essential. Automated data logging ensures a complete, tamper-proof record of temperature conditions for every shipment, providing the necessary data for stability assessments and determining whether product quality has been impacted.

Pharma companies should also implement predefined response protocols, including clear risk-based decision-making frameworks that align with regulatory requirements. Thorough documentation of excursions and corrective actions ensures compliance and facilitates audits.

CP: How are regulatory expectations evolving regarding temperature excursions, and what best practices should companies follow to remain compliant with agencies like the FDA and EMA?

DW: Regulatory agencies are placing greater emphasis on end-to-end temperature monitoring, data integrity, and risk-based decision-making. The FDA, EMA, and other global bodies now require pharmaceutical companies to provide detailed, real-time temperature tracking data instead of relying on manual reports or delayed assessments. These requirements also align with Good Distribution Practices (GDPs), which set the standards for maintaining product integrity throughout the supply chain.

For instance:

• In the U.S., USP 1079 and 1083 outline best practices for temperature control and risk mitigation in pharmaceutical distribution.
• In the EU, the EMA’s Guidelines of 5 November 2013 on Good Distribution Practice of Medicinal Products for Human Use establish clear requirements for temperature monitoring, documentation, and corrective actions.

Comprehensive documentation is crucial for compliance, as these agencies understandably mandate a complete record of temperature conditions, investigations and any corrective actions taken.

To remain compliant, pharmaceutical manufacturers should always opt for validated temperature-controlled packaging, automated temperature data collection, and real-time visibility into shipment conditions. Adopting GDP-aligned solutions ensures compliance while enhancing operational efficiency.

By following these best practices, companies can maintain compliance while reducing the risk of costly product loss or recalls.

CP: What role do CDMOs and logistics providers play in helping pharmaceutical companies prevent, manage, and investigate temperature excursions during storage and transit?

DW: CDMO and Logistics providers assist in the creation of qualified and validated processes and ensure the execution of those processes on behalf of the pharma company. Those can include: ensuring product stability during manufacturing and storage, implementing validated packaging and compliance measures, maintaining temperature integrity during transportation and distribution, and using real-time monitoring and risk mitigation strategies.