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Pharmaceutical & Medical Packaging News, July/August 2015

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pmpnews.com • Pharmaceutical & Medical Packaging News July/August 2015 6 Industry Outlook Industry Outlook: Balancing Requirements with Innovation Packaging professionals are preparing for regulatory changes while addressing cost concerns and meeting deadlines. How much opportunity is there for new product development and innovation? by Daphne Allen Editor S erialization and track and t r a c e . C h a n g e s t o U . S . Pharmacopeia packaging chapters. Changing regula- tions for global distribution. Development and validation costs. Post-approval regulatory changes. Changeover. Cost and budget con- straints. Adapting existing equipment to new materials and to new format parts. Lead time, cost, flexibility, and scalability of new equipment. And did we mention cost? These are the myriad challenges expressed by pharmaceutical and medical device packaging profession- als responding to our 2015 Salary and Industry Outlook survey. (For our feature covering salaries, please turn to page 13.) These professionals are running into challenges as they work to ensure their packages comply with new regulations and standards as well as meet stringent requirements for product protection. Respondents also tell us about challeng- es in new product development, such as finding budget, time, and support. In addition, to understand the purchasing objectives that motivate packaging professionals, we asked respondents to our 2015 Market Segment Study why they are invest- ing in new equipment, materials, and services. Respondents were allowed multiple answers, and more than half (54%) indicated they were motivated to increase manufacturing capacity, 49% were motivated to increase prof- itability, and 46% were motivated to comply with FDA regulations. These objectives were ahead of upgrading packaging materials (29%) and com- peting in a global marketplace (22%). (Please see opposite page for the full list of objectives.) Given such investment objectives, regulatory priorities, and cost con- cerns, are packaging professionals finding the opportunity to explore new materials and potential designs? WRapped up In the RequIRements? Changing regulatory requirements are introducing a significant amount of work in pharmaceutical and medi- cal device packaging. While item-level serialization is not required for the U.S. market for a few years, many U.S. companies are working to meet international requirements. (Interest- ingly, printers are the number-one machine mentioned in the Market Segment Study (see page 10). In addition to preparing for serial- ization, packaging professionals are following changes to several packag- ing-related chapters of the U.S. Phar- macopeia. (See sidebar on page 10.) These changes are concerning our survey respondents. For instance, in terms of serialization, one respondent to our Industry Outlook and Salary Survey speaks of a lack of in-house technical expertise. "Serialization with aggregation is a disruptive technol- ogy," writes one respondent. Anoth- er points out that "newly proposed USP <661.1> and <661.2> requires significantly more extractables and leachables documentation for phar- ma containers and their materials of construction." And another says the "biggest challenges are always from interpretations of existing standards, primarily ISO 11607, and primar- ily issues from European regulatory bodies." Or as one professional says, "same standards, same challenges." P a c k a g i n g e n g i n e e r s a r e a l s o spending time on projects with mate- rials that are undergoing a change (DuPont's transition of Tyvek 1073B and Tyvek 1059B to manufacturing lines that use the latest flash-spinning technology) or an announced closure (INEOS Barex AG's announced clo- sure of its Barex plant in Lima, OH). As challenging as these regulatory and technical issues may be, packaging professionals are also trying to squeeze

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