Despite the high level of chemical durability of Type 1 glass, in rare cases the interactions between the drug and container can lead to safety concerns. Typical problems are glass delamination, particle formation, or leachables from the container. Several recent market recalls occurred, conferences were dedicated to the topic, and an advisory letter was issued from the FDA. We offer screening packages using specialized analytics to assess potential risks and find strategies to avoid them.
Delamination ScreeningAccelerated Compatibility - Testing, Spiking StudiesParticle AnalysisPharmacopeia and Industry Standards Testing
Do you see a risk of glass delamination for your products? We have developed a delamination screening package to assess the likelihood for delamination occuring during the shelf life of your product.
Long before delamination is seen by the naked eye, pre-indicators for delamination can be discovered by appropriate analytical techniques. One single analytical result like hydrolytic resistance is not enough to evaluate the specific interaction between your product and the container wall.
A combination of tests investigating the solution, the container surface, and the surface near region allow a determination for the risk of glass delamination to occur. Together with our knowledge about the various contributing risk factors, these tests can support you in determining the best container to avoid delamination for your specific product.