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FOCUS Laboratories can help develop an environmental monitoring program that is useful form medical device manufacturers. Utilizing principles outlined in AAMI TIR52 Environmental Monitoring for Terminally Sterilized Healthcare Products, FOCUS Laboratories can help determine sample sites, sample frequency, methodology as well as interpret results. For more information on our Environmental Monitoring capability
The amount and type of viable microbes on a medical device must be known to set adequate sterilization measures. Since microbial contamination can be sporadic, bioburden is determined on replicate lots of product, with replicate units from each lot. Typically a medical device is submerged in a rinse fluid and shaken, stomached, sonicated or treated in some other fashion that will rinse the microbial off the device. The rinse is then...
If the device is rinsed with water at any point in the manufacturing process, there is a high likelihood of endotoxin contamination. This endotoxin contamination will not be remedied with post process sterilization. Water used in medical device manufacture should be tested for endotoxin, as well as the medical device itself.
Once the bioburden of the medical device is understood, appropriate parameters can be established for assuring device sterility. Sterility must be verified, and this is typically accomplished by direct immersion of the devices in media and incubation for times prescribed by USP .