Validation of the cold chain in pharmaceutical transport
It’s essential to regularly validate the cold chain in pharmaceutical logistics. Agidens has the expertise and technology to thoroughly analyze, test and document these sensitive processes. This ensures temperature-sensitive medicines are transported under the right conditions.
Cold chain validation in line with the European Pharmacopoeia
A pharmaceutical company turned to Agidens with a clear request: develop a validation protocol for the refrigerated transport of plasma-derived products. The main focus was compliance with the European Pharmacopoeia. This regulation defines in detail which temperatures must be maintained, how companies should continuously monitor and document them, and how often the entire cold chain must be validated.
In addition, key references were taken into account, such as USP 1079 (Good Storage and Shipping Practices), the ISPE Good Practice Guide for Cold Chain Management and the WHO guidelines for the storage and transport of temperature-sensitive pharmaceutical products.
The transport of plasma-derived substances — such as immunoglobulins and albumin — leaves no room for error. These life-saving products are used to treat conditions like immune disorders, bleeding disorders and other critical illnesses. Even minor deviations can irreparably compromise the quality of these medicines.
Custom validation protocol tailored to your company
The first step in the collaboration was a thorough risk analysis, where Agidens identified the specific factors that could affect the cold chain. Based on this, six different transport routes were selected and validated. Three types of vehicles were used: a trailer, a truck and a van, carrying 32, 18 and 4 pallets respectively.
For each route, the transport process was analyzed in detail, within the temperature specifications defined beforehand by the client (≤ -25 °C, ≤ -20 °C and -23 °C ± 2 °C). The validation focused on five critical phases of the transport:
Storage at the departure site
The first step was to verify the temperature at the starting location, ensuring it remained stable before transport began.
Loading the vehicle
Throughout the loading process, the temperature was continuously monitored to ensure it stayed within the agreed specifications.
Transport
During the journey to the final destination, the temperature was closely monitored to guarantee stability.
Unloading the vehicle
During unloading, checks were carried out to confirm the temperature remained stable throughout the process.
Storage at the destination
Finally, the temperature at the destination was monitored to ensure it stayed consistent — a crucial step for maintaining the product’s integrity after arrival.
During each phase, calibrated temperature loggers were used by Agidens’ Validation & Testing consultants, who handled the placement and removal to minimize any disruption to the client’s daily operations.
The collected data provided insights into minimum, maximum and average temperatures, as well as the duration of any temperature excursions outside the predefined ranges. If the temperature remained out of spec for less than two hours, the result was considered a pass. All data were processed and summarized in a detailed validation report for the client.
From compliance to strategic value
Cold chain validation confirms whether transport complies with legal standards and the company’s internal quality requirements. The detailed validation report also serves as crucial documentation in the event of an audit. Since each validation protocol is custom-designed, you can confidently demonstrate that your products were transported under the right conditions.
On top of that, you gain valuable insights into how different factors affect transport temperature, like door openings during loading and unloading. This kind of information helps you design a more sustainable transport strategy in the long run.
Looking for a reliable partner to validate your cold chain?
This collaboration highlights the added value Agidens brings as a partner for innovative solutions that ensure both the safety and efficiency of the transport process, while safeguarding your products.
With over 25 years of experience in mapping, Agidens offers flexible solutions tailored to your specific needs. Our in-depth knowledge of the pharmaceutical industry allows us to deliver not only fast results but also long-term strategic value.
