Pharmapack North America: Protect Today’s New Drugs against Contamination

Today’s pharmaceuticals are increasingly being delivered via novel routes, and many are designed for patients to use when treating themselves. “Drug products are undergoing design revisions, giving changing patient populations user-friendly options,” explains Don Singer, Global Lead Quality Manager, Microbiology R&D, GlaxoSmithKline. “It is not just pills and tablets any more. We are seeing many inhalable and intranasal products, and parenterals are no longer just delivered directly by standard syringes and from vials, especially in the oncology field. There are patient-friendly designs intended for self-injection, and different infusion assemblies. And there are many more preservative-free products, too.”

While easing patient use, these newer products may present another challenge—avoiding product contamination. “Tablets are dry, so they are not as susceptible to contamination as a fluid or a cream,” says Singer. “A robust packaging design is therefore needed for susceptible products to ensure protection against product contamination. The challenge isn’t in manufacturing, but in product use. Because patients will be handling products and in some cases multi-dosing, the challenge will be to maintain microbiological integrity throughout shelf life and use.”

Singer will help engineers look at package designs from a microbiologist’s standpoint at Pharmapack North America June 19 in Philadelphia. “My goal is to foster an understanding between the packaging engineer and the microbiologist so the two can work together on a design sufficient enough to reduce the risk of contamination,” he says. “Traditionally, packaging engineers and microbiologists only worked together when problems arose. Instead, as a continuous improvement strategy, the two should work together from the beginning.”

Singer will be presenting a “life-cycle approach,” in which designs are considered for microbiological protection from beginning to patient use, through shelf life. “You have to think of all the possibilities along the way to ensure that products are protected from microbiological entry or growth until the expiration date. And then you have to consider patient compliance, because patients often use products beyond the expiration date,” he says.

Packaging engineers may already be grappling with this issue, as Singer reports that regulators around the world are increasingly asking about steps taken to prevent microbiological contamination. “It’s not that the interest hasn’t been there before, but there is a new emphasis [on] microbiological safety and building microbiological quality in product design,” he says.

Singer looks forward to helping the Pharmapack North America audience think about prevention. “We are all trying to protect patients. We just have to be aware that more and more there are new concerns. You cannot see microbiological contamination with the naked eye, like you can see glass particulates or container tampering. It is the stuff you cannot see that makes it difficult to understand or prepare for. But asking questions proactively can help.”

Singer’s presentation, “Designing for Patient Safety: Packaging and Microbiology,” will be at will be at 1:15 PM ET on June 19.

--Daphne Allen


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