PolyCHECK® Foreign Material Identification Service

Foreign Particle Identification

The PolyCHECK® FM service enables contamination control engineers and quality managers to identify specific processes and material sources of foreign particle contamination.

Pharmaceutical, medical device, semiconductor and other microelectronics manufacturing facilities devote significant engineering and financial resources trying to solve vexing particle contamination problems. Because specific sources of particle contamination are almost never definitively identified, root-cause corrective actions to prevent yield hits, device rejects, bioburden excursions, tool escalations and CAPAs cannot be implemented.

The PolyCHECK® FM service has been successful in the following situations:

  • Spikes in reject and rework rates in medical device manufacturing despite airborne particle counts being within specification.
  • Identifying the specific source of organic-based fiber contamination in medical device, GMP and microelectronic cleanrooms.
  • Identifying specific processes that generate dark foreign particles in parenteral drugs.
  • Closing open CAPAs with a root cause solution at medical device and GMP pharmaceutical facilities.
  • Compliments USP 788, USP 789, USP 790 and USP 1788 methods.
  • Solving scratch defects, backside wafer contamination and particle escalation events in wafer fabs.
  • Unlike traditional analytical techniques which fall short of providing a definitive source of the particle contamination, the PolyCHECK® system is production-proven at matching the contamination found on the product to specific processes and material sources.

    If your facility has been unable despite spending huge resources to identify sources of foreign material contamination, the PolyCHECK® FM Process can assist you.

    How it Works


    Advantages

    • Our PolyCHECK® Wipes and Swabs are able to collect samples from large and small surfaces very quickly compared to SEM Stubs.
    • Our process does not require the facility or workstations to shutdown.
    • We not only provide a detailed contamination analysis, we help provide a solution for FM removal.

    Our Approach