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Pharmaceutical & Medical Packaging News, November/December 2014

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News pmpnews.com • Pharmaceutical & Medical Packaging News November/December 2014 10 USP Updates Several Chapters in the U.S. Pharmacopeia-National Formulary (USP-NF) T he United States Pharmacopeial Convention (USP) is updating several chapters related to phar- maceutical packaging, a few of which we cover here. The revision of USP Chapter <661> Containers—Plastics has been "a labor of love," says Desmond Hunt, PhD, Senior Scientific Liaison for USP. A revision was needed, says Hunt, "because the chapter was outdated and did not generate data that helped end-users determine the suitability of a packaging material." Now titled Plastic Packaging Sys- tems and Their Materials of Construc- tion, <661> currently includes two subchapters <661.1> Plastic Materials of Construction and <661.2> Plastic Packaging Systems for Pharmaceuti- cals. The chapters were first published in PF 39(5) September/October 2013, and after a comment period and revi- sion process, they were republished in PF 40(5) in September/October 2014. "It's a paradigm shift," Hunt says. "In December of 2013, we had a workshop to discuss the chapters and it was well attended, due to industry's interest in the topic and the potential changes." Calling the revision "industry driv- en," Hunt says that "PQRI's best rec- ommendation practices are built into these chapters. Its recommendations set us on this path." The principle behind the revision is the idea of using "well-characterized materials," says Hunt. "We want to know that a material of construction meets certain requirements, which is the first step in determining wheth- er that material is suitable for a final packaging system. You should have a good understanding of the materials of construction, as well as potential extractables." And in keeping with Quality by Design principles, the approach should enable users "to start with a good material of construction and end with a good packaging system," he says. The new chapters require more test- ing, says Hunt, "but at the end of the day, you will have a better understand of your packaging system." Other subchapters are planned for the future: <661.3> Plastic Systems Used for Manufacturing Pharmaceu- tical Products and <661.4> Plastic Medical Devices Used to Deliver o r A d m i n i s t e r P h a r m a c e u t i c a l Products. Other changes from USP include t h e r e v i s i o n o f C h a p t e r < 6 5 9 > Packaging and Storage Require- m e n t s , w h i c h i s u n d e r w a y a n d planned for publication in PF 41(4) in July 2015. The chapter was initially developed to place all Compendial packaging and storage definition in one place; the chapter became ofcial in 2011. Before 2011, "most packaging defi- nitions were in General Notices and needed updating," says Hunt. "We waited for industry to digest the 2011 revision, which was just moving the definitions with some minor editing. We expect some significant changes, additions, and edits to be appropriate for industry." 3-D Printing Helps Machinery Company Stay Ahead of Packaging Changes B rands that innovate and launch products faster lead the market, says Kevin DePasquale of The Whole Package (Oak Ridge, NJ). "More and more companies are changing con- tainer shapes, sizes, and graphics to standout on the shelf or on the Inter- net," he says. "Consumers are even driving the design of new products through social media," he says. The race to innovate could be why DePasquale is seeing a constant stream of unique tubes these days. "Oval tubes are gaining popularity. We are now seeing caps with appli- cators, square caps, multi-faceted caps, tubes-in-tubes," he says. "The graphics are constantly evolving, get- ting more intricate." He is also seeing more private label products coming to market, with a higher quantity of SKUs with lower-run sizes. Companies are racing to get new products to the shelf quickly, he observes. For The Whole Package, a provider of tube-filling machinery and relat- ed tooling, the speed of innovation requires that changeover tooling be produced rapidly, DePasquale says. To stay ahead of the demand, the company has introduced its Heli-Puck transport pucks that are produced using 3-D printing. "We use 3-D print- ing to build flling-line-ready produc- tion tooling," he says. "While others use 3-D printing just for prototypes, we take it a step further enabling us to support intricate shaped tubes, bot- tles, and jars on the flling line. According to the firm, Heli-Pucks can work with difficult-to-handle tubes and caps. With engineering and manufacturing in the USA, they can be delivered within 3-5 business days.

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