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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 compromise drug efficacy and product shelf life, and cause product recalls.
Factors leading to delamination:
Drug influence
Glass container influence
LDP vials’ optimized manufacturing and dedicated tests make these vials the right solution against delamination phenomenon. Available in EZ-fill® and bulk configurations.
Available Formats: 2R, 4R, 6R, 8R, 10R, 15R, 20R, 25R, 30R both EZ-fill® and bulk
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.
Preserved stability of the drug during its shelf life
Reduced validation activities – No need to re-file drug product
Reduced risk of stability failures and re-trials during development
LDP Vials are the preferred choice for those applications presenting challenging chemical requirements.
Vaccines
Diluents
Biologics
ADCs