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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 12 After further explanation, she shared results from the MPTP study that show that "all are within the func- tional equivalence bounds." Scholla then examined how func- tional equivalence supports inter- changeability. " W e ' v e d o n e c o l l a b o r a t i o n s throughout the value chain with MDMs, sterile packaging manufac- turers, and regulatory organizations around the world, and we've provided a wealth of data for you to use in your documentation," said Scholla. "All this goes into this concept of functional equivalence and how it supports inter- changeability." Scholla said that "interchangeabil- ity allows MDMs to use either current Tyvek or transition protocol material. The concept is that if you have a pro- cess that is validated and you put the transition protocol material through that same process and get an acceptable answer, it doesn't matter whether you are using control or transition protocol material, you are making a decent seal. "There are some things that have to take place to get to that point," Scholla continued. "You have to consider this in your change control risk manage- ment and regulatory submission pro- cesses . . . The specifications for the device package don't restrict the use of either current Tyvek or protocol material." And there should be no changes to the package or sterilization process conditions, he said. "As long as you Investing to Support Pharmaceutical Companies in Puerto Rico V ictor Dixon has been involved with the pharmaceutical and bio- tech packaging industry in Puerto Rico for a number of years, so he's seen the island industry during its up and down cycles. He's supplied these businesses in PR from companies such as Alcoa Packaging, Kimble/Ger- resheimer Glass, and later Cortegra as well as operated the printed packag- ing production facilities of Catalent on the island. And now as President/ COO of Rondo-Pak, he's excited about the company's year-old facility in San Juan. Rondo-Pak is so confident about the new plant, the company is ofer- ing a "zero-cost switching" program to PR-based customers. "Customers typically have to consider the costs of new plates, dies, etc.," says Dixon. "To make a switch to our plant seam- less, we assure customers we'll bear the burden of the costs to switch." Rondo-Pak had already been ship- ping a significant amount of cartons and other materials to PR from its Norristown, PA, facility. "Our customers came to me and said they needed an alternative in their Puerto Rico supply base," Dixon says. "At one time, there was a clear tax advantage in the market, and then that changed as the market matured. In the rollercoaster market, some packaging businesses pulled back from the island. There was also heavy consolidation within the packaging supply chain." After hearing of the industry needs, "we saw the opportunity to serve as a supply alternative in Puerto Rico and also to use this location as a launching board for the Caribbean and other markets," Dixon says. Establishing Rondo-Pak's presence and manufacturing processes in Puer- to Rico allows us to become quali- fied as a "critical industry supplier," Dixon explains, so he anticipates there will be some significant tax advantages to island-based businesses purchasing materials from the printed packaging supplier's San Juan location. "In addi- tion, the company is supporting the local economy by purchasing supplies locally and creating jobs as we grow." Rondo-Pak currently runs a con- t i n u o u s m a n u f a c t u r i n g p r o c e s s beginning at its Pennsylvania plant. Materials are printed in PA and then shipped to Puerto Rico where they are electronically verified and then proceed to final manufacturing. "Our business plan includes continued investments in additional equipment and resources as market growth dic- tates," says Dixon. Rondo-Pak's PR plant is equipped with brand-new versions of the same carton production equipment the firm uses in PA. New equipment includes a Bobst folder/gluer with vision systems for glue inspection as well as defect detection. "Anything we produce in the United States we will be able to Rondo-Pak's San Juan, Puerto Rico, location adds a fourth to its global footprint.

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