Groups Studying Glass Vials

After a year of recalls involving what some call “glass delamination,” industry gathers to investigate.

In 2011, the Parenteral Drug Association (PDA; www.pda.org) and Rx-360 (www.rx-360.org) will be looking at some of the challenges the pharmaceutical industry has encountered with recalls associated with glass vials. Several recalls have involved the discovery of particulate matter inside the vials of injectible drugs.

For instance, as recently as January, Cumberland Pharmaceuticals Inc. recalled six lots of Acetadote (acetylcysteine) Injection, an injectable treatment administered after ingestion of a potentially toxic quantity of acetaminophen. According to a post on FDA’s Web site, Cumberland recalled the items “as a precautionary measure based on observed particulate matter found in a very small number of vials. The source of the particulate matter was from the glass vial produced by a former supplier.” As of January 1, 2011, there were no known adverse medical events, Cumberland reported.

A.J. Kazimi, chief executive officer of Cumberland Pharmaceuticals, reported in the post that the company “switched to a new vial packaging supplier in August of 2009.”

PDA is planning to hold “2011 Glass Quality Conference,” May 23–24. The group says that “there have been several recalls and increasing concerns about pharmaceutical glass packaging, both with regard to defects and/or incompatibilities with finished product over the shelf life.”

International consortium Rx-360, too, will be hosting a one-day scientific symposium intended for companies to be able to share glass delamination experiences and scientific data. Interested parties should contact Rx-360 at kim.rouse@dbr.com.
Rx-360 summarizes data from literature at its site, http://hosted-p0.vresp.com/427409/560d0b0602/ARCHIVE.

But the group wants to dig further, and poses these key questions on its Web site:

•    Why is there a cluster of glass delamination events leading to recalls in the second of half of 2010?
•    Has something changed in the glass supply chain?
•    Is the industry better at detecting glass delamination?
•    Has the industry been sensitized to the issue and is now looking harder for this phenomenon?

Have answers to these questions? Share your own data and experiences by visiting www.rx-360.org.

No votes yet