Re: Acceptable Visible Particulate Size on Sterile Medical Devices ... HELP!!!
What's my utmost concern in this case, however is from a microbiological point of view. What particle size and surface area (i.e. how many particles over a square millimeter pose) a possible threat to the bioburden?
Hi,
Although the issues may be related, there is no direct correlation between the presence of particulate matter and bioburden (at least none that I know of). You colud have high bioburden levels with quite little particulate matter, and, although less probable, higher levels of pariticulate matter presence with resulting acceptable bioburden levels.
You should establish the requirements and controls for these two topics independently.
Bioburden levels should be established upon applicable standards, as part of establishing, validating and maintaining the sterilization process(es).
Particulate matter levels should be established upon clinical application, client requirements and (with the lack of a standard) your own risk management process. It matters a lot what sort of device you make and for what/how it is used.
Operating inside standard certified clean-rooms may be a viable way to control both, once documented requirements are in place.
Cheers,
Ronen.