Glass Delamination Studies
Finding the right packaging for a new drug product is a crucial step that should be taken early in product development. Under certain conditions, glass vials can shed thin, flexible fragments called glass lamellae/delamination. Glass delamination has caused several pharmaceutical manufacturers to voluntarily recall their drug products. In order to avoid this, Glass delamination studies (USP <1660>) for pharmaceutical containers such as vials are necessary to mitigate risks associated with the generation of lamellae (or small glass flakes) from the inner surface of a glass pharmaceutical container.
Our experts at Daicel pharma services offers various analytical approaches like pH, PSD analysis for particles, ICP-MS to monitor for higher amount of glass ions which is indicative glass durability, Studies by Microscopy like inverted microscopy/SEM with EDX to inspect size, shape and morphology even for sub-visible particles that could potentially present from inner vial surface which is an indication of glass delamination.