Low Delamination Propensity Vials - Stevanato Group
search img

LDP Vials

After an extensive investigation on the chemical performance of the inner surface of vials and on the critical glass forming process parameters that influence the final delamination propensity of vials, Ompi launched LDP Vials as a result of an optimized forming process that minimizes the surface inhomogeneities formation.

LDP Vials are produced with Type I Borosilicate glass and have no coating applied ensuring no need to re-file to Official Authorities.

The issue

The delamination of pharmaceutical glass is a serious issue as it can cause glass particles to appear in a vial. The first step is the formation of an altered layer that leads to the separation of thin glass flakes.

 Factors leading to delamination

  • Drug formulation: aggressive buffers, complexing agents, high pH
  • Storage Conditions: temperature, time, etc.
  • Surface Treatments: presence sulfur, coating etc.
  • Process and shelf life: depyrogenation, terminal sterilization, etc.

Delamination may cause

  • Compromised drug integrity
  • Product recalls
  • Reduced product shelf life
delamination MAIN IMAGE

Characteristics & Benefits

  • Higher stability of the drug during its shelf life
  • No glass formulation changes
  • No need to re-file your drug
  • No coatings

LDP Vials, thanks to their optimized forming process, are comparable to the raw material in terms of release of glass elements.

Supplied also in EZ-fill® configuration for your aseptic manufacturing

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


You might also be interested in ...

Chemical Analysis

To detect the risk of chemical interaction with drugs

Ompi - Add-on Components - for Vials - 10395
Vial components

A rubber stopper and an aluminum cap typically comprise a vial closure system

Ompi - Vials - Group - Original - B2 Shooting - 11300

Ompi Vials are offered in different sizes and capacities that can contain both liquid and lyophilized drugs 

Packaging Solutions

Transforming complex processes into compact, coherent packaging systems

Visual Inspection - Exacta Plus 3
Easy Series

Easy line is comprised of user-friendly vision inspection machines featuring still cameras for a reliable and efficient detection

Interested in Low Delamination Propensity Vials?

Submit your request


logo stevanato group
linkedin facebook