MEDICAL COMPOUNDS | MATERIALS
Enabling progress in medical devices
Innovations in medical compounds lead to development of new technologies for patients. Regulatory and market trends also drive changes. Jennifer Markarian reports
Plastics have enabled huge technical advances in medical devices, including the production of surgical tools, wearables, and implants for just a few examples. Plastics also aid performance in packag- ing, in sterile containers and innovative drug delivery forms. In addition, they are the dominant materials for bags, tubes and other equipment for pharmaceu- tical and biopharmaceutical manufacturing. These wide-ranging fields of application employ a variety of polymer and additive types, all of which must comply with standards and regulations for their particular use. This typically involves stringent testing and tracking as well as production in “clean” areas that may include dedicated lines or even dedicated facilities to avoid contamination. One of the biggest challenges for some
applications in these markets is that once a material is approved for use, any future changes must be documented and sometimes require new approval. Innovation continues, however, with the latest developments designed to meet changing needs in sterilisation and materials, as well as considerations for sustainability. Materials used in medical devices and other medical applications must be designed to with- stand sterilisation processes, which can include steam (in an autoclave), vapourised hydrogen peroxide (VHP), ethylene oxide (EtO) gas, and radiation by gamma rays, electronic beam, X-ray, or ultraviolet-C (UV-C) light. Gamma irradiation has been widely used by manufacturers of bags, tubes, and connectors for single-use bioprocessing equipment for biophar- maceutical manufacturing. Demand for these
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components has been growing, and there has been concern that the available gamma irradiation capacity in the US would not be adequate. As a result, component manufacturers have been looking at X-ray irradiation as an alternative sterilisation approach. The global industry organisation, the US-head-
quartered Bio-Process Systems Alliance (BPSA), evaluated both gamma and X-ray sterilisation methods and published its research as a guide in July 2023. BPSA says that the data indicates that the impacts of X-ray and gamma on the plastic components are equivalent, and that the report data can be used to support risk assessments. Another issue affecting sterilisation availability in the US is a proposed rule from the federal Environ- mental Protection Agency (EPA) that could change the standards for EtO emitted from the commercial sterilising facilities, which are widely used for medical device sterilisation. As a result, alternative sterilisation methods are being considered. “Increasingly stringent environmental regula-
Main image: Ineos Styrolution’s sustainable NAS ECO material is used in new Eco-inject autoinjectors
April 2024 | COMPOUNDING WORLD 15
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