Plastikos and Plastikos Medical presently mold medical devices and parts within multiple ISO-7 certified cleanrooms. The new testing system means that the company will collect bio-contamination data from multiple sampling locations throughout the cleanrooms, especially in “risk zones.” The goal is to provide test results with heightened accuracy in relation to cultured results as well as the documentation of trending data over time.
“Adding a level of bio-contamination control to our already proven and certified cleanroom capabilities affords our customers with a level of confidence that few other custom medical molders and medical manufacturers provide. Knowing that our products meet stringent bioburden limits directly increases our customers’ ability to ensure that they are providing a safer finished product to all of their end consumers,” Joe Day, Plastikos’ quality manager, said in a news release.
Medical device OEMs have traditionally engaged in bio-contamination testing throughout the assembly of a medical device to verify bio-contamination levels before the sterilization process. Officials at Plastikos and Plastikos Medical say identifying microbial activity in-house will increase their medtech customers’ confidence that Plastikos parts meet their bioburden requirements.