Common temperature deviation mistakes in airfreight pharmaceutical shipments and how to avoid them
Abstract
Maintaining the cold chain for pharmaceutical products during airfreight is crucial to ensure product efficacy and patient safety and is strictly regulated[1] [2]. This article examines the most common mistakes leading to temperature deviations during airfreight of pharmaceuticals under temperature-controlled conditions. I’ll provide some strategies and recommendations for avoiding these errors and hopefully aid in safe and effective delivery of temperature-sensitive pharmaceuticals.
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Introduction
The global pharmaceutical supply chain relies heavily on airfreight to transport temperature-sensitive products rapidly across vast distances[3].? However, the complexity of this process, coupled with the stringent regulatory requirements surrounding pharmaceutical transport, presents numerous opportunities for temperature deviations to occur[4] [5]. These deviations can compromise product quality, leading to significant financial losses and potential harm to patients[6] [7].
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Common mistakes
I’ll explain several common mistakes found in my own experience and cases know in the literature and conversations with manufacturers and end-users.
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Inadequate Pre-Conditioning:
Problem: Failing to pre-condition pharmaceutical shipments to the required temperature before transport. Not adhering to the pre-conditioning time stated by the manufacturer of the pharmaceuticals and/or not adhering to the validated requirements of the packaging[8] [9] [10] [11].
Solution: Implement robust procedures for pre-conditioning shipments in temperature-controlled environments, allowing sufficient time for the products to stabilize at the required temperature. Logistical managers should be aware that planning to do stabilisation of the packaging should not take place at end of a shift, because it can be “hastily” be processed, because workers want to go home resulting in deviations in pre-conditioning times.
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Incorrect packaging:
Problem: Utilizing packaging materials that are not suitable for maintaining the required temperature range during airfreight[12] [13] [14].
Solution: Employ validated packaging solutions specifically designed for temperature-sensitive pharmaceutical transport[15], including appropriate insulation, coolants, and temperature data loggers. Additionally ensure the packaging is validated by the sender and/or receiver to ensure the risk of deviations with packaging is as low as possible.
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Improper Handling:
Problem: Exposing shipments to extreme temperatures during loading, unloading, or tarmac transfers due to inadequate handling procedures[16] [17] [18] [19].
Solution: Train personnel on proper handling techniques, including the use of temperature-controlled vehicles and minimizing exposure time to ambient conditions. Awareness of the shipment, that focus on the end user (a.k.a. the patient needing the medicine) will help increase awareness and acknowledgement that proper handling is important.
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Ineffective temperature monitoring:
Problem: Failing to adequately monitor temperature throughout the entire transport process, including during unexpected delays or route changes[20] [21] [22].
Solution: Utilize real-time temperature monitoring systems with alarm capabilities to detect and address temperature excursions promptly fortunately this is more and more advance[23] [24] [25].
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Lack of contingency planning:
Problem: Not having contingency plans in place to address unexpected delays, equipment failures, or other disruptions that could jeopardize temperature control[26] [27] [28].
Solution: Develop comprehensive contingency plans, including alternative transport routes (lane assessments), backup equipment, and procedures for responding to temperature excursions.
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Conclusion
Preventing temperature deviations in airfreight pharmaceutical shipments requires a multifaceted approach encompassing meticulous pre-conditioning, validated packaging, proper handling, robust temperature monitoring, and comprehensive contingency planning. Much you have to comply with already by adhering to international guidelines and best practices, such as those outlined by ISO, GDP, GMP, PIC/s. However risk mitigation is essential to ensure and aiding in the safe and effective delivery of temperature-sensitive pharmaceuticals to patients worldwide.
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Per usual feedback welcome and hope you have a great day,
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