MATERIALS | MEDICAL
Above: Regulatory and quality requirements for medical materials continue to ramp up
role as many generic pharmaceuticals also require the approval of a suitable drug delivery device.” Other factors affecting the market include
increasing regulatory and quality requirements. Duckworth adds that tightening requirements by regulators on materials necessitates a much better understanding of the polymeric substances incorporated, such as additives and colourants. This influences the effect they have on leachables – defined as substances that could migrate out of the plastic into the drug or the patient. There are now many examples in European Medical Device Regulations (MDR) and In Vitro Diagnostics Regulations (IVDR) in Europe, and USP regulations in USA. The term “well-characterised materials” appears frequently in these new regulations. There are also stronger responsibilities for the moulder in terms of the design, quality and regula- tory responsibilities, as well as in change manage- ment. It is no longer acceptable for a converter wanting to participate in medical applications to say that regulatory issues are its customer’s responsibil- ity. Emphasis is much more on risk-based assessment and Quality by Design. This means that end-product quality and ability to meet regulatory requirements need to be considered at the start of the process, rather than using standard plastics and then testing. In addition, there is a much stronger emphasis on change notification and control. Even small changes in the plastic and ingredients, such as a pigment, can make much of the product and process validation testing no longer valid. This can cause problems with leachables and even mechan- ical reliability. The cost of re-testing can be from $40,000 for a simple extraction test, to many hundreds of thousands for a full re-validation – not to mention the cost of a product recall. Covid-19 has driven demand for plastics consumption in masks and other personal protec-
14 INJECTION WORLD | January/February 2021
tion equipment, however, the pandemic has also accelerated other trends that were already present. “For example, Point of Care Testing was bringing diagnostic testing closer to the patient, increasing speed of diagnosis,” says Duckworth. “Pregnancy testing and self-analysis of blood-sugar levels are early examples of this, but it is clear the pandemic has shown why speedy, accurate, reliable diagnos- tics saves lives. Plastics play an important role in the collection of samples through blood collection tubes, for example, or in laboratory analysis through pipette tips, reagent containers and laboratory automation using colour identification.” He says: “Looking to the near future, wearable devices are moving from fitness monitoring to medical-condition monitoring. For example, an Apple watch has been approved as a medical device, and wearable and connected devices can automatically adjust a dose from an insulin pump. Given that these devices need to be comfortable and conformable to many different body-forms, soft flexible TPE compounds are in demand.”
Self-treatment Self-medication is another area where plastics are proving invaluable. Chronic diseases, such as diabetes and lung disease, are still increasing rapidly. Duckworth adds that traditional methods of treatment involving visits to a medical professional for an injection linked to diabetes treatment have been increasingly replaced by self-treatment using an auto-injector pen. These auto-injectors are mechanically complex with multiple parts using several types of polymers that play a vital role in the dose-accuracy and reliability. These auto-injec- tors are no-longer just used for diabetes, but for a wider range of treatments. Technologies and products already developed for other industries, for example laser marking in automotive and in electrical, are now also finding medical applications. Problems in using these technologies have often resulted from the conserv- ative approach of the medical industry, and evaluation versus the specific regulatory require- ments of healthcare, such as biocompatibility. These trends require new approaches and medical grades, not only in polymer resins, but also through functionality resulting from additives in polymer compounding. Duckworth cites some examples. Ever more complex designs, increased reliability and faster assembly have seen an increased use of laser-welding, developing an increased need for colour and additives that allow selective absorption and transmission of laser energy. Applications are in diagnostics, drug
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IMAGE: SHUTTERSTOCK
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