Low Delamination Propensity (LDP) Vials
After conducting extensive research on the chemical performance of the glass vial inner surface and the glass forming process parameters, Stevanato Group added SG LDP Vials to its portfolio. These containers are specifically designed to minimize the formation of surface inhomogeneities.
SG LDP Vials are produced with Type 1 Borosilicate glass and have no coating, meaning that there is 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
2R, 4R, 6R, 8R, 10R, 15R, 20R, 25R, 30R both SG EZ-fill® and bulk
Benefits
Higher stability of the drug during its shelf life
No glass formulation changes
No need to re-file your drug
No coatings
Comparable to the raw material in terms of release of glass elements
Benefits
Higher stability of the drug during its shelf life
No glass formulation changes
No need to re-file your drug
No coatings
Comparable to the raw material in terms of release of glass elements
Preferred Market Choice
Vaccines
Diluents
Preferred Market Choice
Vaccines
Diluents