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Pharmaceutical & Medical Packaging News, July/August 2015

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11 July/August 2015 Pharmaceutical & Medical Packaging News • pmpnews.com leachables from the fnal/actual container closure system (after washing, sterilization, irradiation) should be performed." While <381.1> covers injectables and <381.2> inhaled drug products, future planned chapters are expected to cover elastomers used in manufacturing sys- tems <381.3> and elastomers used in devices <381.4>. Michael Ruberto, president of Material Needs Consulting, spoke about the new USP chapters pertaining to plastic packaging. "All materials can produce leachables," he said. "Chemicals can migrate from packaging, devices, and processing equipment." To understand what is an "actual" (a leachable; in the presence of the drug or drug compo- nents during normal use) and a "potential" (an extractable; determined in the lab to predict worst-case conditions of exposure), engineers need to design extraction studies, and then determine what is appropriate for a given application, he explained. "There's no premarket clearance for materials used in pharmaceutical packaging," he added. Ruberto said USP's vision with its < 6 6 1 . 1 > , < 6 6 1 . 2 > , < 1 6 6 3 > , a n d <1664> chapters is to have engineers or scientists frst characterize plastic materi- als or resins (covered in <661.1>), then move to packaging systems (covered in <661.2>). These subchapters will point to <1663> for extractables and <1664> for leachables, even though those latter chap- ters are for informational purposes since their chapter numbers are above 1000, he said. The point is to arrive at a "well- characterized system," he explained. "If you have well-characterized materi- als, chances are you will have a well- characterized container that is suitable for packaging pharmaceuticals. You have the fexibility to decide based on risk." What if a pharma company has a prod- uct already on the market in a particular packaging system? It is grandfathered under <661.1>. However, if the packag- ing system is used with a new drug, then the plastic resin and packaging system must be tested according to <661.1> and <661.2>, respectively. "Individual plastic materials of construc- tion are deemed to be well characterized and appropriate for use if they are used in a packaging system that meets the rel- evant specifications in <661.2>," he explained. "Materials must meet the speci- fcations in <661.1>, and there are a vari- ety of tests to be performed as needed for biocompatibility and physiochemical test- ing. However, extractables and leachables testing isn't necessarily required for the container closure systems for all dosage forms—<1663> and <1664> allow for fexibility and a risk-based approach." "On the surface, it might seem like the new and revised USP chapters will simply mean additional testing for the industry," he tells PMP News. "However, the data and information gained from this testing will help to ensure that the materials used to package our pharmaceutical products will be suitable for use." Sparks encourages communication with USP. "Persistent efforts through written comments and collaboration with the Packaging, Storage, and Distribution Expert Committee (Senior Scientifc Liai- son, Desmond Hunt, Ph.D.; dgh@usp.org) and industry colleagues are important and can help achieve and maintain prac- tical and meaningful packaging standards for the future," he says. If you have further questions, please contact Ruberto at michael.ruberto@ materialneedsconsulting.com and Sparks at dlsparksservices@gmail.com. tamper evidence and serialization. Added Powers: "We are spending more time interpreting the regulations and how we are going to comply. Consider glued-end cartons for the EU directive—component suppliers can help us with packaging that can meet many of these regulations." "Contract manufacturing and pack- aging can help us through," he added. Such external support may also help packaging professionals manage reduced internal resources. "Resourc- es are constrained," explained Ho. "There are no more 40 or 50 in a packaging development group—those days are gone. There is some outsourc- ing, but you lose some knowledge." Packaging performance is critical, and manufacturing must be flexible. "We also need better barrier packaging and still get the product to patients fast," said Powers. "And manufacturing will be moving more towards on demand, instead of manufacturing to inventory. "We could standardize our packages on a global basis, qualifying them for the most aggressive regulatory or stability requirements," he added. "We could do more with less and focus our resources." Berghahn would like to see an increase in manufacturers' origi- nal packaging. Even when "we see full enactment of DQSA, we'll still see counterfeits because we are still repackaging and [manufacturers' original packaging] stops at the phar- macy dock door," he said. Sustainability is also "high on our list," added Powers. "When we devel- op new packaging, we look to lower our carbon footprint." Based on such perspectives, it seems that the pharma industry is evolving incrementally toward a more patient-focused package, but develop- ment of such packages cannot hold up product launches, and regulatory compliance definitely comes first. And as the industry introduces packaging innovation, it looks for support from suppliers, contract service providers, and others to help them manage regu- latory compliance, speed to market, and cost-efectiveness. That's not to say that disruption won't happen outside the industry. In July, pharmaceuticals and other med- ical supplies were carried on a flight authorized by the FAA and operated by NASA. The drone, a hexacopter oper- ated by Flirtey Inc., delivered the prod- ucts to a free clinic run by Remote Area Medical and the Health Wagon at the Wise County Fairgrounds in Virginia, it was reported in a news release. Even with such disruption, though, packaging will likely play a role. When asked whether disruption will be the

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