December 1, 2022

Added medical device packaging simulation tests

Plastic is a vital material for modern healthcare applications due to its versatility. Its uses have continued to evolve with this dynamic industry. However, this can present environmental concerns in some respects, especially when it comes to single-use plastic. According to the Healthcare Plastics Recycling Council (HPRC), in 2020, more than 32 billion pounds (14.5 million tons) of medical plastics were produced worldwide – the majority of which is disposed of in landfills or through incineration although most are uncontaminated and recyclable – and that number is expected to reach 48 billion pounds by 2025. As the focus on sustainability rightly continues to increase in the medical device and pharmaceutical industries, finding a means of minimizing the flow of waste and its environmental and climate impact is becoming increasingly important. an absolute priority. As corporate “reduce, recycle, reuse, recover” goals impact their business operations and resource investments, many OEMs recognize that meeting their sustainability goals must include strong from their supply chain partners.

Today’s OEMs rightly expect their partners to adopt environmentally responsible practices. New regulatory requirements are emerging that require healthcare providers to include durability as a supplier selection criteria, and durability questionnaires are increasingly becoming a requirement for OEMs to bid in hospital environments. Packaging, which is a key part of the supply chain and critical to protecting and delivering the product to its point of use, has been specifically identified as a driver for future sustainability gains. There is a significant opportunity to reduce waste through increased innovation in healthcare packaging design and optimization of processes and materials.

As more customers look to improve the sustainability of packaging options and include more recyclable packaging components, manufacturers of medical device packaging are increasingly emphasizing the sustainability of their products. products and their operations. Greater sustainability and reduced waste can best be achieved by optimizing packaging design – which can reduce material usage, as well as improve packaging functionality and allow for better product protection during sterilization, shipping, transport and storage. Packaging manufacturers may seek to reduce packaging, eliminate unnecessary components, streamline shipping where possible, and some are even working with end-user hospitals to increase education on proper recycling and reuse.

At the individual packaging level, ways to reduce product footprint include optimizing form factor (size, weight), material chemistry, recycled content and recyclability, all of which can have a overall impact. The balance is between the degree of improvement sought and the opinion of the prescriber on the acceptable complexity of the change, the interpretation of the regulations, the level of impact required and, in some cases, the country or the health situation in which the product will be used.

Informed packaging changes should be made with quantified and significant impacts in mind, while maintaining technical safety margins and ensuring the product performs as intended. Packaging manufacturers must make the change and deliver the impacts at a pace that matches the OEMs’ corporate commitments – in one example, aiming for a 25% reduction in packaging waste by 2025, which is a pace change faster than before.

A commonly used approach to accelerate and reduce the risk of change, and to enable broader evaluation at an early stage in the packaging design process, is the use of in silico simulation. This involves virtually modeling potential performance and producing a narrow list of high-probability options for in vitro evaluation through conventional physical assays.

Simulation analysis has been tailored to address the challenges of thermoformed medical plastics, presenting stakeholders with intellectual data to verify, communicate and clearly understand the complex information needed to effectively select valuable solutions. Simulation can give packaging engineers and their medical device OEM customers valuable insight into the performance of a packaging design early in the process without investing in creating physical samples to experiment/test. This type of simulation testing can now be applied to design for durability. By identifying Critical Quality Attributes (CTQs) early and promoting more optimal designs, simulation reduces unnecessary use of product components and raw materials, and prevents unnecessary manufacturing and transit defects in the longer term. packaging systems.

Simulation techniques can replace physical design review with virtual evaluation. This uses finite element analysis to model the physical dimension of characterized materials transforming these “digital twins” on rendered molds into final packaging formats. In silico evaluation allows the impact of small to gross changes in form factor, mold design, material thickness and even alternative materials to be assessed. As a virtual process, machine time, tool production and availability constraints are circumvented. The output derived from a simulation is highly quantized.

Simulation can, for example, be used to optimize lightening by modeling the thickness of each finite element through the formwork, as well as identifying points of failure. This can reduce a product’s greenhouse gas footprint, including waste, logistics emissions, and energy used in manufacturing. Minimum safety thresholds of material to pass can be extrapolated to give optimized design decisions, backed quantitatively to support or prove the changes. Identifying points of failure enables in silico redesigns of mold rendering, evaluating mold changes that could allow for ultimate relief.

Conclusion

Good product design promotes increased sustainability by minimizing the amount of waste that ends up in landfills or incinerators and reduces the environmental impacts caused by the production of virgin plastics. In a literature review conducted by HPRC, Life Cycle Assessment (LCA) “studies comparing recycling to other disposal methods concluded that recycling had a lower environmental impact than landfill or incineration with recovery energy, especially because of the advantages of avoiding the production of virgin plastic”.