![]() To date, these constraints have retarded the widespread use of the VHP sterilisation method, but the process and chemistry are relatively more compatible with the materials, making this a suitable alternative for implantable sensor systems. ![]() However, when used in an industrial setting, the sterilisation equipment and support systems must undergo installation, operations and sterilisation validation which can be time-consuming and costly. The FDA has granted 510(k) clearance for the use of various models of vapour sterilisation systems to terminally sterilise medical devices (K083097 6 K071385 7). Because hydrogen peroxide breaks down to water and oxygen, aeration time is greatly reduced and any concern for toxicity is very low risk. Compared to EO gas, VHP typically cannot penetrate large, dense packaging, but it can offer an alternative where material compatibility with EO is a problem. Vaporised hydrogen peroxide (VHP) sterilisation is a low-temperature gaseous method of sterilisation. When protecting the performance of the implantable sensor is critical, neither extra time nor cost will prevent these alternative sterilisation processes from being the method of choice. ![]() Other less conventional, less frequently used methods may be considered as suitable alternatives for implantable sensor systems, because these systems have different performance and risk priorities compared with large volume, low cost disposable medical devices. Duncan, in Implantable Sensor Systems for Medical Applications, 2013 8.3.5 Alternative sterilisation methods: considerations for implantable sensor systems ![]()
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June 2023
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