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Pharmaceutical & Medical Packaging News, November/December 2015

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Interview • Pharmaceutical & Medical Packaging News November/December 2015 18 Addressing Particles in Drug Packaging Particles have been cited in a number of drugs recalls. Two professionals from West Pharmaceutical Services discuss a few ways to address them. A t Interphex earlier this year, Jennifer Riter, Senior Director, Global Analytical Services, and Andy Polywacz, Vice President, Quality Assurance, at West Phar- maceutical Services Inc., discussed the challenges dealing with particles in drug packages in the presenta- tion, "Particles Causing End of Line Rejects and Drug Product Recalls: Overcoming Packaging Challenges and Need for Adequate Controls." PMP News asked Riter and Polywacz to share more details and what steps pharmaceutical firms should take. PMP: Jennifer, you have stated that analytical testing typically relies on older methods—what are those? Riter: ISO 8871 has been the stan- dard for analytical testing for more than 20 years. It provides a strong basis; how- ever, there have been several develop- ments in packaging materials since that time. At West, we're taking a different approach by going beyond ISO 8871 to take into consid- eration the specific chemical properties of materials commonly used today, includ- ing new elastomer formulations. PMP: You have described that the challenge would be to develop specific methods for each particle type—can you offer examples of particle types? Why would each need its own method? Riter: Particles can come from elastomers themselves or from the environment. After the diferent types of elastomers are washed and pre- pared, they go into various types of packaging before reaching the custom- er. Therefore, it's important to take into consideration whether there is any particle burden within that packaging that the elastomer could take on before it is shipped it to the end-user. Each particle type requires its own method of analysis because the meth- odology for properly identifying the level of particulates can vary. For example, a clear fiber may require dif- ferent lighting when you're looking at it under a microscope versus a gray type of particle that may have abraded from the elastomer. You may not be able to see everything under one focus or under one light source. It's impor- tant to incorporate multiple method- ologies of identification and analysis to ensure the accuracy of your data. PMP: You've said it is also hard to answer this question: how do you remove particles? So does this challenge mean that suppliers/users should work upfront to ensure that packaging, people, and environments have minimal amounts of particles in the first place? Should maxi- mum thresholds be set and expected? How would this be monitored? Riter: There are a variety of dif- ferent ways to remove particles—it all depends on the surface chemistry of the material you're using, and the proper way to remove that particle from the surface area. For example, one might utilize a surfactant, or water, or both combined. Other approaches include vacuuming the particles of of the material's surface. Whatever methodology is chosen, one must be careful not to pull out addi- tional particle from within. Polywacz: In order to ensure the best quality drug product and optimal patient outcomes, it's important for drug manufacturers to foster a col- laborative efort with their packaging suppliers from the beginning. By work- ing closely with our customers early in the drug development process, we are able to clearly understand what the specific containment and delivery requirements are for their drug product and select the appro- priate packaging and delivery systems and materials. Addition- ally, we encourage our pharmaceutical partners to examine the potential for particulates across the entire supply chain, right down to the end-user. These early conversations allow us to set appropriate thresholds and ensure we're meeting those thresh- olds throughout the entire process. For example, we need to consider the particle load throughout the supply chain—including other facilities, mate- rials, and processing involved in the production and delivery of the drug product—to ensure that we're mitigat- ing any additional burden that may exist later in the process that could impact the final quality. West takes an active role in supporting our phar- maceutical partners in this process, working collaboratively to develop a solution for the total supply chain. Jennifer Riter Andy Polywacz

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