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When we first reported on the Chiron flu vaccine debacle several weeks ago, the incident was still officially under investigation. Since that time, the ugly truth has come out. Recent FDA inspections at Chiron’s British manufacturing plant found that the contamination of more than 48 million flu vaccine doses occurred during the all-important process of filling the vaccine vials. As soon as that was discovered, British regulators suspended Chiron’s manufacturing license, citing poor manufacturing practices and bacterial contamination in nine of 100 lots produced at the plant.

Unfortunately, you know the rest. It has since been reported that none of Chiron’s doses will be salvaged, leading to a sense of panic in the United States as federal officials have confirmed that this year’s vaccine shortage is now dangerously low. In fact, 100 million people are currently thought to be at high risk if they catch the flu. Following the Chiron announcement, only about half the required vaccine is now available to treat this at-risk group.

As a result, the pressure is on Aventis (Bridgewater, NJ), the company currently handling the flu vaccine supply. Aventis had already finished making its 52 million flu vaccine doses when it learned about Chiron’s troubles. But instead of being relieved at finishing its job, the company now must fill 2-3 million additional doses per week. And now more than ever, the filling and processing of those extra doses are of utmost importance.

That’s why a new FDA guidance on aseptic processing couldn’t have come at a better time. The publication, “Guidance for Industry: Sterile Drug Products Produced by Aseptic Processing—Current Good Manufacturing Practice,” was first issued in 1987. FDA’s new version contains sections on blow-fill-seal processes, personnel, isolator technology, and rapid-test methods for identifying microbes.

But perhaps the biggest change to the document is the very one that will have the biggest impact on Aventis and hundreds of other companies — the updated and enhanced requirement for media fills in process simulation. The guidance now puts more emphasis on worst-case conditions, such as conducting media fills with operators who are fatigued, rather than at the beginning of a shift.

In the introduction, the document states, “Clarifying relevant regulatory standards for sterile drug products will help reduce the incidence of manufacturing problems with this class of pharmaceuticals, thus facilitating the ready availability of these therapeutically significant pharmaceuticals and avoiding drug shortages.” It also suggests “it is critical that containers be filled and sealed in an extremely high quality environment.” The guidance adds that “equipment sterilization, media fills, polymer extrusion, product-plastic compatibility, forming and sealing integrity, and unit weight variation are key issues.”

While one might conclude that this document is a case of too little, too late, in light of the Chiron flu vaccine situation, FDA should be applauded for doing its part to make sure such events never occur again. And that’s precisely what makes this guidance an important document at an important time.

Ben Van Houten