FEA Engineer at Nelipak Healthcare Packaging Samuel Ambosta discusses the positive effects of FEA and simulation on medical packaging quality.
The FDA and other governing bodies are increasingly accepting simulation as a means to develop products more efficiently. Evidence-based engineering requires costly and time-consuming rounds of physical testing. But shifting to intellectual-based approaches which use meaningful data generated via simulation (also known as Finite Element Analysis, or FEA) adds significant value and supports greater product innovation, reduces costs, improves sustainability and speeds time to market.
What is FEA or simulation?
Simulation is a numerical method for solving engineering and mathematical physics challenges. It can be used to analyse materials or objects, mimicking real-world manufacturing process with appropriate assumptions to find how stresses affect design in a 3D computing world. For medical device packaging design, it can be used to help determine points of weakness in a potential product, while reducing or sometimes even eliminating the need for resources to be spent on development of a physical prototype.
Simulation analysis has long been used by the injection molding sector, and is now being adapted to meet the challenges of thermoformed healthcare plastics, presenting stakeholders with intellectual data to clearly verify, communicate and understand the complex information required to select valuable solutions efficiently. Simulation can give packaging engineers and their medical device OEM customers valuable information about the performance of a package design early in the process without investing in the creation of physical samples for experimenting/testing.
FEA not only has the power to efficiently solve real-world problems such as plastic thinning, cracked flanges, seal creep and product migration, but also reduces design churn, through models developed for thermoform packaging. It offers the opportunity to save valuable time, money and other resources and mitigates risk by exploring “what if” scenarios, allowing mechanical engineers and material scientists to predict outcomes and design safety factors accordingly, removing uncertainty from package designs and improving the speed to market. Simulation is also a powerful analytical tool for product investigation and root cause analysis to understand field failures of existing products in the market which have met customary testing standards.
How simulation works
Design and development teams can take a computer-generated CAD file, coupled with specified physical properties of the plastic, to create finite element models and predict the performance of the thermoforming and product integrity.
With NeliSim Finite Element Analysis, two types of simulation may be performed: Thermo-Forming Simulation, which simulates the limitation of final product using minimal resources; and Transit-Test Simulation, whichdetermines predictability in product performance during product integrity testing. This provides insightful data on factors such as minimum wall thicknesses; shows material deflections that may result in cracked flanges and seal creep; and leads to a better overall understanding of product limitations before entering physical testing protocols – leading to higher first-time-right outcomes.
The engineering team can provide a simulated view of the complete package, as opposed to only assessing the performance of select components individually. Assessing the product as a whole provides a higher degree of confidence that the thermoformed piece is accurate to reality.
Designing for improved sustainability
The transformative product development enabled through simulation may lead to improved sustainability and lower costs. By identifying critical to quality attributes (CQA) early and driving more optimal plug designs, simulation reduces unnecessary product components and raw materials usage. Additionally, effective simulation prevents unnecessary manufacturing and shipping of defective product.
Conclusion: simulation for product development
With the physical modeling and testing methods currently used by medical device companies, unforeseen issues may not materialise until late in the process, resulting in delayed lead times and additional costs. Use of simulation helps to reduce design churn, establish design best practices early on and ultimately helps bring effective products to market more expediently. By allowing customers to accurately assess predictability of packaging performance and have a better edge of failure understanding, in the end the customer gets a higher quality product.