Cold-chain shipping containers: Quality matters

Active Container Quality

The adage “quality begets quality” — a fundamental underpinning of all mechanically engineered systems — should be top of mind when shipping time- and temperature-sensitive pharmaceutical products. Reliable container performance has direct implications for every stakeholder in the critical chain-of-custody efforts required to efficiently distribute these pharma products across the globe without temperature excursions that can create costly and potentially catastrophic consequences.

Elements of a Quality Container

The overall active container quality directly affects the ability to package, condition, store, ship and deliver temperature-sensitive pharma products and ultimately weather the storms (both actual and proverbial) that will inevitably arise along the route. Reliable, successful delivery of lifesaving therapies and vaccines has both clinical and financial implications. Understanding what goes into building and maintaining a high-quality container is vital for every manufacturer, freight forwarder and airline to maximize reliability and minimize risk.

Container quality begins the moment a new container is initially conceived, however, the key areas where you should focus attention include:

  • Overall engineering design
  • Raw materials for manufacturing
  • Operating principles and procedures
  • Continuous improvement

Design for Quality (DFQ)

As previously implied, the design of any active container is essential to long-term quality and performance. Because pharmaceutical products generally have strict temperature requirements over long durations, you should look closely at critical components like the insulation, heating and cooling system, air circulation system and how each affect performance.

Insulating materials come in a variety of forms and compositions. Thanks to steady advances in vacuum insulation panel (VIP) technology, active containers insulated with top-of-the-line VIP provide maximum R-value and minimum thermal conductivity — both measures of peak insulation performance.

We all know air circulation is essential for maintaining a consistent temperature in our homes, vehicles, etc. But it’s even more critical inside an active container that must ensure products arrive at maximum efficacy. Even one hot or cold spot in the container could lead to spoilage of a portion of the payload. The key to eliminating this risk is through optimal temperature mapping and consistent airflow circulation. These two systems work together to control the temperature effectively and reliably inside the cargo space. Containers with optimal temperature sensor placement allow for tight temperature control set-points and broad ambient operating ranges, meeting robust qualification standards. Consistent airflow circulation is required on all sides of the payload. Enveloping the entire payload with conditioned air evenly provides bulk-loading capabilities for maximum payload volume inside the container and long-term savings for all parties.

This combination of advanced design elements allows high-performing temperature-controlled shipping containers to maintain pharmaceutical products within their tightly specified temperature ranges – refrigerated, controlled room temperature, frozen or deep-frozen – during long-duration transit and storage, even in in the face of extreme ambient temperatures.

Managing container quality over time for peak performance

While design and material choices are critical to building a high-quality container, maintaining container performance is equally imperative to meet the stringent requirements for pharma shipments. User operation is yet another component of a successful shipment that requires significant attention. Navigating these elements of quality once a container is in use should not be overlooked.

If a container is difficult to use or your container provider doesn’t offer adequate training for those operating it, you expose your shipments to additional risk of excursion.  Everyone involved in the shipment should follow the standard operating procedures (SOP) provided by the container manufacturer and adopt a robust and consistent quality framework and training protocols. Adhering to an SOP is essential to ensure proper and consistent container use, maintenance and troubleshooting. Another hidden benefit — it supports auditing and product-traceability requirements.

Last, but certainly not least, is maintenance. Preventive maintenance is a must if you want to be confident that any container you receive – regardless of age – will perform as well as one newly off the manufacturing line. Your container provider should conduct regular container inspections, annual validation testing and routine preventive maintenance efforts to replace key components preemptively. In this era of heightened environmental responsibility and sustainability, ensuring the longest possible service life also creates an important environmental dividend.

Improving container quality through shipment visibility

End-to-end shipment visibility in active containers for the pharmaceutical cold chain was a long time coming. Now that it’s here, container manufacturers have the opportunity to use the aggregate data to enhance continuous improvement efforts for container quality. Analyzing the data from individual sensors for interior temperature, ambient temperature, shock and tilt, door opening, etc., engineers will gain insights using real world scenarios to improve the quality and performance of existing containers and future fleets.

Ultimately, a high-quality active container significantly reduces excursion risk and can provide a competitive advantage for pharma manufacturers, forwarders and airlines. If your primary mission is to put therapies and vaccines into the hands of prescribers and patients at maximum efficacy, remember – quality begets quality.