Foamtec International has devised a 5 step (or systematic) process to address the leading concern of foreign material (FM) contamination for medical device manufacturers.
For medical device manufacturers, FM related rejects are the most visible cost but also significant are lengthy inspection protocols, re-work, non-conforming material reports (NCR), and corrective and preventative action (CAPA). While the costs can be counted upwards into the millions of dollars a year, the problem eludes continuous improvement efforts because of the inability to identify the source(s) of the contamination.
In order to assist our clients in the medical device manufacturing industry, Foamtec has developed a comprehensive analysis system that not only identifies but also significantly reduces the sources of contamination generated in medical device clean rooms. This process has been so successful in achieving client goals that several large medical device manufacturing sites have adopted this process internally.
A leading manufacturer of microcatheters approached us with FM contamination as their top reason for manufacturing rejects. The client's average reject rate was 6% and the rework rate due to foreign material contamination was just over 50%. Moreover, the rework process greatly impacted productivity at the manufacturing site. Thus the ideal solution was to identify the source of contamination so that the root cause corrective action can be taken, thereby reducing the number of rejects significantly.
To identify the main source of contamination, specialized FM sampling swabs and wipers were used to collect FM contamination from the rejected devices and critical work stations. These samples were then subjected to SEM/EDX and FTIR analysis. The results from the analysis pointed out fibers as the main source of contamination. See the video of our 5 step analysis process below.
As the data above makes clear, the main source of contamination was polycellulose fibers that corresponds to the heavy use of polycellulose based nonwoven wipers in the cleanroom. Foamtec foam wipes were then implemented as a remedial action to prevent rejection of devices due to FM defects. The figure to the right shows Foamtec products were able to bring about a significant reduction in both in-process and final scrap rejection due to FM contamination, therefore increasing the profit margin of the medical device manufacturing site significantly.