Glass delamination has emerged as a significant problem for the pharmaceutical industry, causing the recalls of numerous injectable drug products over the past several years, at the cost of as much as $50 million per recall. The FDA has reacted to these recalls by taking a serious interest in how companies ensure their drug products are stored safely. There is no single factor that causes glass delamination in a pharmaceutical setting, and it can be a difficult problem to address because it typically doesn’t show up until the product has been stored in the container for several months. Because of the complexity of the problem and the delay before the problem appears, there is no simple fix once delamination has been observed. Nevertheless, there are concrete steps that pharma companies can take to minimize the risks of glass flakes. The key is to conduct container/drug product compatibility testing prior to commercialization. Accelerated testing of both the drug product and the candidate containers, together, can identify potential problems in as little as a few weeks, simulating the shelf life for a product under standard storage conditions. Undertaken as part of an engineering, stability, or clinical trial, such testing can help to prove that the product can be stored safely. This article outlines why glass delamination occurs and, more importantly, how pharma companies can use accelerated testing to pick the right containers for their drug products and avoid costly recalls.
