In response to multiple adverse event reports related to the sloughing of lubricous coatings off intravascular catheters, guidewires, balloon angioplasty catheters and delivery sheaths, device manufacturers have devoted significant resources to improve coating operations.
While there are many failure modes in coating operations, foreign material (FM) contamination is often the most significant cause of inspection, rework and rejects. Given that FM directly impacts coating integrity, device manufacturers have upgraded clean rooms, garments, coating equipment and invested heavily in air ionizers in order to improve contamination control.
Despite these measures, FM remains a major failure mode and often leads to corrective and preventative action (CAPA’s) that cannot be closed with root cause solutions.
To reduce costly rework, defects and open CAPA’s, coating and quality engineers need a method to identify the sources of FM so that they can be targeted for reduction.
To aid device manufacturers, Foamtec has developed a sampling and identification service that is detailed in the following link:
Pictured below are FM and material sources in ISO 5-8 cleanrooms by Foamtec’s FM collection and Identification service.
Shown Above: Utilizing SEM/EDX instrumentation, FM is traced back to polycellulose non-woven wipers, bouffant caps and shoe covers recovered from a hydrophilic coating room.
Shown Above: Polycellulose and polyester fibers were found as FM contamination on a hydrophilic coating line
Shown Above: Using FTIR instrumentation, Foamtec was able to match the fibers found on the coating line with the catheter manufacturer’s current cleanroom wipers, bouffant caps and shoe covers.
For more information regarding FM Sampling and Identification, please contact us at www.foamtecintlwcc.com/contact