It could be argued that the most important and challenging steps in the manufacture of medical devices are contamination control and sterilisation. There are several reasons why these steps must always be foremost in the minds of manufacturers, the first of which is that failure to adequately detect and eliminate bacterial loading at any point in the manufacturing process puts at risk the most important element of the bottom line: the safety of medical patients who can be infected through a device that is supposed to help them.
In recognition of the seriousness of this risk, producers of medical devices are required to meet regulatory compliance standards for contamination control during the manufacturing process. There are also strict regulations governing bioburden testing and industrial sterilisation after all the components have been assembled.
There is no ‘cookie-cutter’ formula for meeting these standards because each device presents its own challenges. So each manufacturer must devise its own protocol for carrying out bioburden testing, documentation and sterilisation.
Meanwhile, ISO 14644, which provides the worldwide standard for designing and validating controlled environments, is under review, with possible changes pending.1 Currently there is no industry-wide consensus on what level of environmental bioburden is acceptable, making validation a moving target.1
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