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LDP Vials

LDP Vials: Low Delamination Propensity for Drug Stability

LDP vials clear glass

LDP vials

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

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

Scientist performing Analytical Test with SEM

Factors leading to delamination:

Container Interaction

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
Vial

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 EZ-fill® and bulk configurations.

Optimized inner surface for drug stability

Features

  • Low Delamination

    Lower delamination propensity

  • Compatibility Drug-Container

    Lower risk of container interaction with drug product

  • Vial

    No coatings or glass chemical composition change

  • Optimized Process

    Optimized forming process

  • Surface Characterization

    Dedicated analytical test for product release

Filling volume Crimp Finish
2R * 3 mL 13 mm
4R 4 mL 13 mm
6R 8 mL 20 mm
8R 8 mL 20 mm
10R 10 mL 20 mm
15R 15 mL 20 mm
20R 20 mL 20 mm
25R 25 mL 20 mm
30R 30 mL 20 mm

* Upon request

Additional formats are available upon request.

LDPvials_amber_glass

Vials in amber glass with LDP process for​ light-sensitive drug products

These vials are designed to meet Light Transmittance tests and are supported by dedicated analytical testing for product release, along with a Delamination Propensity test protocol, making them suitable for drug products with challenging requirements.

The LDP process is also available for amber glass vials for light‑sensitive drug products.

Amber vials are designed to meet light transmittance requirements and are supported by dedicated analytical testing for product release, together with a delamination propensity test protocol, making them suitable for drug products with challenging requirements. 

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.

  • 199_Chemical molecule

    Vaccines

  • 348_Water_diluent

    Diluents

  • 199A_Biologic molecule

    Biologics

  • 236_Monoclonal_Antibodies

    ADCs

Discover product range, features and advantages of LDP Vials

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Nexa® Glass Vials

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Fina® Glass Vials

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LDPvials GAQ

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