LDP glass vials: drug safety and stability | Stevanato Group - Stevanato Group
Explore our LDP glass vials designed to minimize delamination risk, ensure drug stability, and preserve patients’ safety extended shelf life for the most challenging applications.
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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

LDP vials’ optimized manufacturing and dedicated tests make these vials the right solution against delamination phenomenon. Available in pre-sterilized EZ-fill® and bulk.

Optimized Inner Surface. The Science Behind LDP Glass Vials

31 Low Delamination
Lower delamination propensity
24 Compatibility Drug Container
Lower risk of container interaction with drug product
17 Vial
No coatings or glass chemical composition change
81 Optimized Process
Optimized forming process
66 Surface Characterization
Dedicated analytical test for product release

Available Formats: 2R, 4R, 6R, 8R, 10R, 15R, 20R, 25R, 30R both EZ-fill® and bulk

Higher Drug Stability and Preserved Drug Integrity with LDP Glass Vials

Benefits
91 Filled Vial

Preserved stability of the drug during its shelf life

25 Regulatory Expertise

Reduced validation activities – No need to re-file drug product

66 Surface Characterization

Reduced risk of stability failures and re-trials during development

Versatile and Reliable: Applications of LDP Glass Vials

LDP Vials are the preferred choice for those applications presenting challenging chemical requirements and for the most challenging formulations.

Preferred Market Choice
199 Chemical Molecule

Vaccines

348_Water_diluent

Diluents

199A Biologic Molecule

Biologics

Low Delamination Propensity Vials Brochure

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