LDP Glass Vials: Low Delamination Propensity for Drug Stability

Delamination of pharmaceutical glass consists in the separation of thin glass flakes from vial surface which start floating into liquid drug.

Delamination can cause compromised drug efficacy, product recalls, and reduced product shelf life.

Factors leading to delamination:

Drug influence

• Drug characteristics: aggressive or sensitive formulation, high pH level, low filling volume
• Drug storage conditions: temperature, time
• Drug production process: vial depyrogenation, terminal sterilization

Glass container influence

• Vial properties and production process: glass tube chemical composition, heat temperature
• Vial surface treatments: sulphuration, internal coating