Over the past 40 years, there has been a significant change in how medical devices are manufactured, principally, from the use of metal and glass to medical grade polymers for single-use and disposable products. This shift, combined with more stringent regulations to more accurately address issues related to infection control, prompted the previous major change in sterilisation from steam autoclaving (often applied at the point of use, such as hospitals and doctors’ offices) to a requirement that products are delivered sterile by the manufacturer.
With continuing industry changes, including new regulatory initiatives such as Unique Device Identification (UDI), and additional cost pressures, such as the 2.3% medical device sales tax imposed by the Obama administration in the US, medical device manufacturing would benefit from a new approach to sterilisation that addresses manufacturers’ needs and fits with their workflow processes.
Medical devices must meet stringent regulatory requirements, such as ISO 13485 – which governs the manufacture of medical devices, including the requirements for medical devices to be designated sterile. Sterility is typically defined by demonstrating a reduction in the bacterial load to a Sterility Assurance Level (SAL) of Log 10-6.
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