“Each final container for all parenteral preparations shall be inspected to the extent possible for the presence of observable foreign and particulate matter…in its contents.” [USP<1> Injections]

An international biotherapeutic company was recently cited in a 483 letter from the Food and Drug Administration (FDA) regarding the presence of black particles in its drug product.  The company had failed to properly inspect for particulate matter.

All container closure systems should be properly inspected.  Use of a vision inspection machine can help drug manufacturers reduce the occurrence of finished final drug product loss caused by component quality issues and improve manufacturing processes by optimizing throughput.  Properly inspected components will reduce manufacturing costs by reducing waste and the need for supplementary resources, such as QA, engineering and production planning.

Vision inspected machines should review component for:

• Adhered and embedded contamination
  
• Trimming defects 
  
• Molding defects
• Hairs and fibers
• Other defects specific to a particular product or customer specification

West employs technically advanced, automated vision inspection systems to ensure that our Envision^TM components meet enhanced quality specifications.

For more information about vision inspection or any of West’s other enhanced processing services, visit our Products page on westpharma.com.

Ron Mueller
Manager, Technical Customer Support
(610) 594-2927
Ron.Mueller@westpharma.com