Visual inspection of lyophilized product

Which type of defects are found in lyophilized we can detect glass particle and black particle in lyophilized cake.

type of defects

  1. cosmetic defects- loose seals, mold defects (molded vial)
  2. volume (cake height) low / high
  3. black particle

for inspection of glass particle and particulate matter following two steps need to follow.

  1. during collection vials used for leak test analysis can be reconstituted with WFI and checked for particulate matter.
  2. 100% inspection of glass particle to be achieved by use of X-Ray inspection m/c.
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