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Pharmaceutical Manufacturing and Packing Sourcer

Ideas in Transit

Developing a passive cooling system that can protect temperature-sensitive pharmaceuticals in storage and transit requires considerable research and testing, but there are plenty of ways to make the process as painless as possible

There is now a wide range of insulated packaging technology available to ensure pharmaceuticals arrive at their destination with their integrity intact, but choosing the right solution for a particular application can be problematic with so many options available. By far the best way to overcome this problem is to gather as much information as possible on the needs of the application in hand. This level of understanding is particularly important in the case of a passive cooling system (as opposed to electrically powered and controlled active systems). There are several areas for consideration when developing passive cooling systems; tackling these in a logical order will make it considerably easier to find the right solution for a specifi c application.

Information Gathering

Crucial to the entire development process is a sound understanding of the needs of the drug being shipped, the conditions that can be expected, and the logistical infrastructure that exists along the supply chain. Without this information it is extremely diffi cult, if not impossible, to fi nd an effective solution. This may seem obvious, but the initial information gathering stage is often overlooked, leading to a considerably over specifi ed, and therefore over priced, system or packaging that fails to do what is required of it. To avoid these pitfalls, the requirements of the packaging system should be clearly understood before design and testing begins.

Perhaps the most obvious factors to consider are the needs of the drug itself. What are the temperature parameters that need to be maintained, and do these limits apply to both storage and transit or just storage? Often a packaging system will be developed to keep the product within a specifi ed temperature range for the duration of its journey unnecessarily, leading to additional development time and cost, when a simpler solution would protect the drug more effectively. In addition to understanding the temperature requirements of the product, it is important to ascertain other relevant information, such as what the dimensions and thermal mass of the drug will be, and in what quantities it will be shipped.

Once the needs of the item being shipped are understood, knowledge of how it will be handled is required. For example, what modes of transport will be used, which organisations will be involved, and will there be any checkpoints or borders to navigate? The answers to these questions are necessary in order to determine how physically robust the system will need to be and if there are any limitations that need to be applied to the dimensions or the weight of the packaging. Perhaps the package will need to fit onto a certain size conveyor or comply with the restrictions of a particular airline or distribution company. It is worth noting that shipments can often run into problems at customs or storage centres, where they may be held for some time without adequate facilities to meet their requirements.

When creating a system for temperaturesensitive drugs, an important area to understand is the environmental conditions that are likely to be encountered along the supply chain. The ambient temperature exposure for a package can alter dramatically between the cargo hold and the airfield, the warehouse and the loading bay. Only by collecting detailed information on the different transport steps of the shipping process can the design requirements of the solution be confidently compiled.

It is this preliminary information gathering stage that makes it possible to develop a temperature controlled system that is both fit for purpose and cost effective. The next steps, from the initial prototyping to field testing and implementation, will all depend on the quality and volume of data collected. This really can’t be stressed enough; the more accurate the information you have, the more likely it is that you will be to find an effective solution in an acceptable timeframe.

Finding a Developer

Once this wealth of product and application information has been collected, a company needs to be chosen to help develop the packaging system. There are now a number of contract companies (such as testing service laboratories) offering temperature-controlled packaging testing, but it is important to find out if they have the specialised skills and experience required to help find the most effective solution. A sound knowledge of the theory behind testing distribution packaging is, of course, essential, but alone it can lead to problems that could have been foreseen if an experienced specialist developer of temperature controlled systems was chosen.

A specialist packaging company is likely to have access to data from hundreds or even thousands of previously built bespoke solutions, allowing development to take place founded on real life examples rather than textbook theory. This can allow you to make substantial savings in the time and money needed to develop your packaging. Furthermore, a specialist provider will typically have the dedicated equipment and facilities necessary for testing temperature controlled systems at each stage of the design and qualification process, providing reliable, data-driven evidence of how the packaging will react in certain scenarios.

While many packaging development companies now promote the use of mathematical models to predict the performance results of thermal packaging, this can be risky if carried out in isolation. Thermodynamics is a complex area that makes theoretical prediction extremely difficult without the use of sophisticated models and a complete understanding of the thermal properties of the packaging system, materials and thermolabile product. To be confident of achieving accurate results and a successful outcome, a developer should be chosen that has the capacity to combine thermodynamic, mathematical and computer modelling, and iterative thermal development or refinement in a laboratory (in accordance with a suitable test protocol, for example the ASTM or ISTA standards referred to in many of the published guidelines).

Get Qualified

Developing a bespoke temperature-controlled packaging solution involves several stages of qualification to ensure the system can be implemented with confidence. These qualification processes take place both in the laboratory and out in the field.

The initial factor is design qualification (DQ), which is intended to provide evidence that the component specifications and system assembly offered by the packaging specialist are capable of consistently operating within your design requirements; that is, the system is able to maintain the product temperature stability for the required amount of time in all conditions. DQ is one area in particular where previous experience of developing packaging systems is useful, as the specialist will be able to find a solution to suit specific requirements more quickly, based on knowledge from the numerous other systems they have worked on in the past.

Once the packaging design has passed this initial stage, it can then move onto operational qualification (OQ). The OQ stage subjects the packaging to controlled testing to show that it will function repeatedly and reliably within pre-determined limits and tolerances. So that these ranges can be simulated accurately, OQ is typically carried out under laboratory conditions. This stage should only be carried out when a proposed solution has been found; if it is applied to a number of development prototypes there will be too many variables involved to achieve qualification reliably

OQ is essential to achieve an accurate picture of the packaging performance, but it is not the end of the testing process. Realworld testing is also required, known as performance qualification (PQ). This next stage is used to provide evidence that the packaging solution, in addition to the facilities and processes used to ship it to its destination, perform effectively and reproducibly. Compatible materials are shipped through actual distribution lanes to ensure the system will behave in the field as determined in the laboratory. In a ‘real’ situation, there will be many more variables that can affect the system’s performance, a number of which will have been impossible to account for in the lab. This is why testing the solution in the field is vital.

Data logging technology is essential in PQ. Data loggers are small recording devices that can be placed inside the packages to record the temperature throughout the distribution process. Any period of time the drug spends outside its pre-determined temperature parameters can be measured and logged, providing the development company with accurate information that can speed up the qualification process considerably.

Conclusion

Shipping temperature-controlled pharmaceutical and medical products successfully and in accordance with the latest laws, regulations and guidelines can be complex and time consuming. However, thorough information gathering and a structured testing programme are vital to make sure the process can be carried out as quickly and reliably as possible. By working with a packaging specialist that is able to provide the expertise and facilities to design and test a bespoke solution that meets your specific requirements, a passive cooling system can be developed and implemented efficiently and confidently, ensuring your pharmaceuticals arrive at their destination with their integrity intact.


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Geraint Thomas is Technical Director at Laminar Medica. Geraint graduated from Brunel University in 1996 with a BSc in Industrial Product Design. After working as a Board Game Engineer for Hasbro toys, he joined Laminar Medica in 1998 as a Packaging Development Technologist, with responsibility for packaging solutions and qualification packages for insulated shipper design. Geraint has been instrumental in realising Laminar Medica’s development programme, including the expansion of the company’s qualification laboratory and R&D facility. Email: g.thomas@laminarmedica.co.uk
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