Medical

FDA Current Good Manufacturing Practices (cGMPs) require that producers of medical devices monitor and control product quality.  The “c” in cGMP –“current”– compels the manufacturer to pursue continuous improvement by updating systems with innovative technologies that increase process reliability and efficiency.

Clinton high voltage pinhole detectors produces instant process validation by providing  100% quality control on the line.  They are also used to fulfill the requirement that manufacturers inspect incoming material or verify that their subcontractors do so.  By FDA estimates, 15% of recalls are due to substandard purchased material, so this process is essential.

Units placed on film lines replace unreliable and sometimes expensive inspection methods.  Plastic parts can be tested individually or in batches as part of the production process.  Testers can also locate defects in catheters and plastic corrugated tubing.


 

Applications

  • Films, barrier products
  • Laminated plastics
  • Respiratory and vascular tubing
  • Blister packs
  • Test tubes and pipettes
  • Pacemaker and fine medical wire