PDA Letter Article

Cracking the Challenges of Glass Packaging

by Roger Asselta, Genesis Packaging Technologies

VialsWe all remember well early this decade there was a significant spike in the number of drug recalls related to glass packaging. There were concerns that the problems associated with glass quality were contributing to certain drug shortages. The U.S. FDA took the unusual step of issuing an advisory to drug manufacturers on the Formation of Glass Lamellae in Certain Injectable Drugs in March 2011.

In response, PDA and FDA cosponsored the first Glass Quality Conference in Washington, D.C. that May. The program focused on identifying and understanding the causes and considered possible solutions. That conference was very well attended by stakeholders at every level in all areas of parenteral packaging. Glass suppliers and pharmaceutical users, scientists and regulators, people in package development, quality, pharmaceutical manufacturing, and testing. In the next two years, additional conferences were held where the focus began to shift to potential solutions and controls to assure glass compatibility to the drug product, fitness for use and patient safety.

It has been nearly seven years since the FDA advisory and five years since our last Glass Quality Conference. Since then, much work has continued, with important research being completed and published. Reliable analytical test methods have been developed. New process controls, glass handling practices, and inspection techniques have been implemented. Pharmacopeias have been revised to make them more relevant to these concerns. Improved glasses are being developed and offered.

In our upcoming 2018 PDA Glass Quality Conference, Jan. 23–24, we will review where we are and explore many of the developments that have occurred during the last few years and look to our future in the field of pharmaceutical glass packaging. Additionally, the conference will include an exhibition of glass, packaging, testing facilities, glass inspection and equipment companies over the dates of the conference. And of course, there will be opportunities to network with friends and colleagues, old and new.

Learn more about the 2018 PDA Glass Quality Conference.

2018 PDA Glass Quality Conference