Cleaning Critical Surfaces in Cleanrooms
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Close CAPA’s, Reduce Rejects through a Deep Understanding of the Sources of FM
Foamtec’s Fully Equipped Cleanroom Forensics Lab
1. We Gather Evidence and Clues.
Foamtec has developed an innovative, cleanroom compatible sampling system that enables contamination to be collected from the manufacturing line. The samples are tagged, logged and packaged so it remains intact on its way to the lab.
Packaged Catheter Rejected for Foreign Material Contamination
Catheter Contaminated with Fiber Based Foreign Material(FM)
Devices, Polycellulose Wipers, and Cutting Tools were Bagged, Tagged, and Sent to be Analyzed
2. We Analyze the Data.
Via SEM/EDX & FTIR instruments contamination is matched to materials and processes in order to develop root cause solutions.
Foamtec’s Highly Trained Staff is experienced in identifying sources of contamination
3. We Find the Contamination Source.
When the analysis is finished, it is easy to see where the FM originated from. Root cause based preventative action can be taken.
FTIR Results Show a Match between the White FM Found On the Catheter After Being Cleaned and the Polycellulose Wipers used to Clean
FTIR Results Show a Match between the Red FM Found Inside the Unopened Catheter Package and Red LOCTITE Material on the Hand Tool
4. We Provide a Solution.
Finally, FM related CAPAs can be closed with a root cause solution.
