FDA issues guidance on glass contamination
pharmafile | March 29, 2011 | News story | Manufacturing and Production |Â Â FDA, GMP, glass contaminationÂ
The FDA has issued an advisory to pharmaceutical manufacturers on the topic of contamination with thin glass fragments – or lamellae – after a series of cases in recent months led to recalls.
The agency is urging manufacturers to review their supplier quality management programmes to make sure that this phenomenon is not occurring.
In 2010, generic methotrexate made by Sandoz, Amgen’s Epogen (epoetin alfa) and Baxter International’s Hylenex (hyaluronidase recombinant) were among the medicine batches recalled because of the presence of lamellae in product vials.
“Under certain conditions, glass vials can shed thin, flexible fragments … from the interior surface directly into the drug and are difficult to detect by visual inspection”, notes the FDA.
While there have been no recorded incidents of side effects resulting from the presence of the lamellae in drug vials, the agency is concerned that shards accidentally injected into a patient could cause embolic, thrombotic or other vascular injury if given intravenously, and local reactions such as granulomas if injected subcutaneously.
There are some risk factors to look out for in preventing lamellae, says the agency. For example, vials made using a tubing process are subject to higher levels of heat than those made by other processes and are less resistant to shedding, while sterilisation can also reduce the stability of glass containers.
Some drugs are also more prone to this kind of contamination, for example those formulated in alkaline solutions and with certain buffers, notably citrate and tartrate. Lamellae are also more likely to form with long shelf-life products and those stored at room temperature rather than refrigerated.
Drugmakers can minimise the risk of lamellae formation in products by selecting higher grades of glass, such as high-resistance, non-alkaline earth borosilicate glass.
Phil Taylor
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