When shipping temperature-sensitive pharmaceuticals, maintaining an unbroken cold chain is essential to ensure product integrity.
Failure to do so may result in anything from a reduced shelf-life to the drugs being rendered completely useless, which means
significant costs. If the products are being shipped for clinical trial purposes, the losses can be even greater, as the cost
of R&D of a new drug is at stake — which was recently estimated to be $800 million (€550 million).1This critical nature of cold chain shipping is driving new levels of investment in controlled packaging solutions that have
been developed to protect pharmaceuticals that are shipped by land, air or sea — often through extreme and varying temperatures.When specifying a temperature-controlled packaging solution, an organization must choose between an off-the-shelf solution
or a bespoke system tailored. The decision largely depends on the value of the products to be shipped, and the potential repercussions
of the drugs straying outside their acceptable temperature range. Whatever the choice, any system must be verified and qualified
to ensure the likelihood of success, and to bring the packaging up to date with the latest guidelines and regulations.
Key points
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These guidelines are provided by various independent institutions such as the Parental Drug Association (PDA), a leading provider
of information and education for the pharmaceutical and biopharmaceutical community. PDA recently updated its technical report
on best practices for developing, validating and qualifying temperature-controlled packaging systems to offer more detailed
advice on shipping goods globally, recognizing the extended distances and durations now being covered.2Test for successWith the level of technical knowledge and resources required to develop a controlled packaging solution that can adequately
protect temperature sensitive drugs, manufacturers and clinical research organizations (CROs) are increasingly working with
specialist providers of packaging solutions. Whether a prequalified system is chosen or a brief given to develop a bespoke
solution, a number of processes should be performed to ensure the correct system is chosen.
Typically, the packaging specialist will initiate the design and testing process by providing a detailed needs assessment
form that covers:
- project description
- project scope
- deliverables
- schedule
- product description
- transit medium
- duration required
- threshold temperature
- ambient temperature ranges
- product stability
- logging
- container type.
These criteria are essential to finding or developing a solution meets the pharmaceutical organization's technical and commercial
objectives.
Once the initial client research is complete, project development and design analysis can begin. Software modelling programmes
and mathematical models are used to begin a preliminary analysis and to develop the thermal solution. Sometimes, a degree
of prequalification may be achievable, based on the specialist's knowledge and experience gleaned from previous projects or
by using off-the-shelf packaging solutions.
During this process, communication between customer and supplier is essential to ensure that the needs of the solution are
fully understood. Usually, designs are revised and refined through a number of permutations. Testing chambers improve the
designs by subjecting the proposed package to likely temperature ranges to come into contact with in real life applications.
By thermally mapping the payload volume, it is possible to identify high and low temperature points to ensure the product's
thermal variations are controlled at all times.
For any temperature-controlled packaging system, qualification testing is necessary to guarantee the proposed solution and
shipping procedures will be able to protect the products being distributed under the conditions expected. It is important
to document this testing as reports are likely to be required during shipment to prove the solution used is qualified. These
reports contain information such as verification of the testing parameters used; performance results; data acquisition location
diagrams for each test performed; and, importantly, dated signatures from both the author and approver.
