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European Pharmaceutical Contractor

Real World Simulations

Ground-breaking simulation technologies, previously unavailable to the healthcare packaging industry, are making huge strides in assisting with the development of cost-efficient temperature-controlled packaging systems

Simulation and virtual prototyping is becoming an important and indispensable stage in the development of robust, cost-effective temperature-controlled packaging, especially when project timeline pressures are a major factor. Technology such as computational fluid dynamics (CFD) was originally used to simulate airflow over aircraft bodies in the late 1960s. However, since then the method of simulating 3D flows and heat transfer has been coupled with the ability to replicate phase change, and this software is often referred to as multi-physics (MP). This innovative technology is used in many industries worldwide and is often known as the digital development of a product. This means that the initial development phase is performed virtually on a computer, before any prototypes or initial testing is carried out.

Used primarily in the automotive and aerospace industries, MP is now becoming more popular and accessible for many niche industry sectors, including temperature-controlled packaging suppliers. In essence, it is the same software that Formula 1 racing teams use to simulate the airflow of the body of their cars to improve aerodynamics. NASA uses MP to simulate the thermal stress that will be placed on a satellite orbiting Mars, utilising the software to predict how much radiated heat the craft will be exposed to and thus design heat shields to sufficiently protect the fragile inner components. Even weather forecasters use it to predict climate conditions and how the effects of global warming will change our weather patterns in the mid-to long-term. In fact, MP is now being used extensively in almost all complex design and test development projects worldwide.

Breaking the Mould

The use of MP and CFD software in the packaging industry is relatively new and has really only been available for the past few years, whereas in industries such as aerospace and automotive it has been a standard development tool for at least 10 years. Due to its widespread use and the accessibility of this new technology, the packaging industry is now able to consider its use for developing complex temperature-controlled solutions for its pharmaceutical clients.

These simulation capabilities enable packaging suppliers to significantly increase the efficiency of the design process and allow for a more expansive and innovative exploration of design solutions to meet customer requirements. In fact, a test using MP technology will take approximately one tenth of the time that it would take to run a physical test in a laboratory.

Instead of buying two new test chambers, manufacturers are now able to consider investing in a simulation workstation and reap the benefits of having a more in-depth insight into the products they are developing. This powerful tool means that packaging suppliers can quickly produce ‘virtual’ prototypes and qualify their performance in a fraction of the time that traditional methods take.

However, in order to fully understand the term ‘MP’, let’s first take a look at it in context. Ultimately, MP is a descriptor of computer simulation for physical phenomena. It was one of the first applications of digital computers, and continues to be a contributing factor in the progress of scientific computing today. The software programme is used to simulate how a temperature-controlled packing system will perform when it is exposed to a certain external ambient stress heat load. It works by creating a 3D CAD model of the temperature-controlled packaging that is to be tested, which includes the various insulating materials, the temperature stabilising components and the product in the shipper, with temperature variables being associated with each part.

Traditionally, when developing and testing a new temperature-controlled packaging system for a client, suppliers would undertake a number of iterative design qualification tests, taking into account the transit duration time and variable temperatures the package would expect to face during transport, in order to configure a shipping solution in the laboratory: a process which, if undertaken in real time, could take months.

Depending on the complexity of the project and the number of variables to take into consideration – such as testing with minimum and maximum product loads and multiple ambient profiles – there are a number of design qualification tests each solution needs to pass before producing a system that will fulfil the client’s requirement. Furthermore, each time any change in the configuration is made, such as moving a coolant component from one position to another, or adding one or taking one away, each design qualification test has to be repeated in the laboratory against each different variable, in order to know whether or not the shipper will perform as required.

For example, if a laboratory test takes five days to perform in real time, packaging suppliers will initially have to wait five days before they know whether or not their first configuration of a system will work. By using MP, a virtual design qualification test can be performed, and although the results are not always 100 per cent accurate, they give an extremely strong indication as to whether a packaging configuration will be good enough to move it to the laboratory for the physical design qualification test. So, in essence, rather than undertaking a three-month development phase in the laboratory, it can be cut down to three weeks using the MP software. Consequently, rather than providing a replacement for physical testing, MP facilitates an initial condensing of the development period, which enables suppliers to fulfil their customer’s requirements that much sooner.

Forward Thinking Innovation

Another insight that the MP software allows for is a more in-depth understanding of other aspects of design, such as airflow within the system, as well as being able to predict how a shipping system could be affected if it is subjected to ambient profiles different from those to which it was originally qualified. This can offer peace of mind to customers who wish to use a particular system on a new, unqualified shipping lane.

MP also enables temperature-controlled packaging suppliers to see how energy (heat) is transferring through a shipping system. During a physical test, thermocouples are attached to the product load inside the shipping system to record the temperatures at those discreet locations. Unfortunately, they are unable to show how energy is being passed through the shipping system or where the hot and cold spots are outside of that payload space, which may have an effect on how it performs overall.

By using MP, the whole shipping system can be analysed to include the insulation, coolant components and product load area. Hot and cold spots can be identified and the flow of energy (heat) in and out of the shipper from external surfaces can be seen, identifying exactly how the external ambient environment is affecting it. Furthermore, it can give a complete picture of the solid/liquid phase of the coolant components in the shipping system, rather than (in a physical test) just seeing that the components have melted when the box has been opened after the test is finished. The software also simulates the phase change of the coolant components, showing the detail of a frozen (solid) component melting during the simulation into its liquid phase. This makes it possible to view the transition accurately to pinpoint the end of the phase change period, which is critical when designing cost-effective shipping systems.

Ultimately, this means that over engineering shipping systems could actually become a thing of the past. MP provides a better understanding of how to design the shipping system with exactly the right amount of energy absorbing phase change material to ensure internal payload temperatures are maintained within the correct range for the desired transit duration. This means that the old design method ‘safety buffer’ can be removed, while still providing confidence that the shipping system is fit for purpose.

Setting a New Standard

Time is of the essence and packaging suppliers are striving to do all they can to reduce lead times associated with the supply of high-quality temperature-controlled systems in order to meet the time- and temperature-sensitive demands of pharmaceutical companies. In fact, the software can run a simulation for a 120-hour transport route in approximately 12 hours and there is no set up time involved. This is where MP really comes into its own, because the more complex the shipping system, the more efficiencies can be gained by using the software.

Information on how a product may perform can be obtained a lot quicker, so the development time is shortened. This means that products can be launched to market in a shorter timeframe, and from an efficiency point of view, products can be engineered to see if they perform as well as they need to in the marketplace using as few materials as possible, so there is an environmental saving as well.

During the design qualification phase, fewer materials are used in the final product design, so there is less waste being put into the environment. Furthermore, a virtual computer simulation reduces the amount of physical laboratory testing in the development stage. Rather than having to receive costly prototype materials and run the environmental chambers, which use a lot of energy, that stage is taken out and replaced with a virtual development stage.

In addition to shortening the development time of a shipping system, the software can simulate different styles of product that a customer might be shipping inside one temperature-controlled packaging system. For example, a specific temperature-controlled solution may be developed in the laboratory and signed off with one product type, such as a freeze dried powder, but how will the same shipper handle the transportation of another product, such as a liquid product, inside a vial? How would changing the product affect the performance of the shipper and how well would that configuration protect different styles of product being transported? The answers to these questions can be derived by simulation using the characteristics of each product type, tested against the previously qualified solution in the laboratory. By doing so, the results can be compared without the need to re-run those laboratory tests in real time.

Furthermore, if the developed shipping system needs to be used on a different route and experiences different temperatures to which it has been qualified for in the laboratory, the software can simulate how the shipper will respond to those different ambient profiles. So if a shipper that was used to distribute products to Europe now needs to be transported to China or South America, the software can give an indication as to how well it will perform by using different ambient profiles to test against. This demonstrates efficiencies as it does not require having to redevelop a whole new set of shipping systems. Instead, it can simply appraise how well the shipping system performed
before, against a new set of challenges.

Conclusion

In our ever-growing and fast-paced global healthcare market, anything that can reduce time in order to help get life-saving pharmaceuticals to market quicker, without increasing the cost, may sound too good to be true. Offering a tool such as this may appear more costly to a customer wishing to source a temperature-controlled packaging system. However, the development cost of a solution is likely to be lower, as the lengthy and costly development phase will be significantly less than traditional initial laboratory testing. The availability of MP technology to this sector now enables temperature-controlled packaging suppliers to provide their data quicker, more accurately and with additional insight.

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Richard Wood has worked in various design and manufacturing engineering functions during his career. He is currently Design Manager at DS Smith Plastics Cool Logistics, where he has worked since 2005. During this time, he has been involved in hundreds of bespoke, customerdefined projects. Richard has also helped to ensure that manufacturing practices are standardised across the Cool Logistics partners network. His role is focused on standardising development, qualification and manufacturing practices to help support the company’s global customer base.
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