Which type of defects are found in lyophilized product.how we can detect glass particle and black particle in lyophilized cake.
type of defects
- cosmetic defects- loose seals, mold defects (molded vial)
- volume (cake height) low / high
- black particle
for inspection of glass particle and particulate matter following two steps need to follow.
- during collection vials used for leak test analysis can be reconstituted with WFI and checked for particulate matter.
- 100% inspection of glass particle to be achieved by use of X-Ray inspection m/c.