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Pharmaceutical & Medical Packaging News, November/December 2015

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19 November/December 2015 Pharmaceutical & Medical Packaging News • pmpnews.com PMP: When are particles ok? Polywacz: There will always be some level of particle burden. Particles can either be intrinsic, i.e., an expected output of the material or process being used, or extrinsic, meaning that they're originating unexpectedly as part of the manufacturing process. If particles are found to be intrinsic, we work pro- actively to put processes in place to ensure that the risk of particles is miti- gated before it gets to the patient. For example, filter needles and other types of delivery devices can help mitigate any intrinsic particulates from getting to a patient. If an extrinsic particle is found, additional time and analy- sis is required to identify the source and update manufacturing processes accordingly. PMP: You also said that pharma companies do not always understand the magnitude of particle analysis. Can this point be expanded? Riter: A thorough analysis of par- ticulate matter is a complex, custom- ized process, and we work closely with our pharmaceutical partners to ensure that we design a testing and analysis process that best meets their expec- tations from the very beginning. We have to look closely at all the diferent factors that could affect the particle testing. For example, if you are utiliz- ing a flask to extract the particles into a solution, you will need to consider how the shape of the flask can affect the data around particle burden. A wider flask might have a diferent efect than a narrow flask. Going beyond running ISO 8871 and understanding every part of the analyti- cal test and what impact it has on the result are important. Every product and its intended purpose are diferent, so it's important to recognize that the analytical process cannot be one size fits all. PMP: Andy stated that there is a need for new standards—what are those? Polywacz: How a drug is manu- factured and delivered to the patient is incredibly important, and quali- ty standards need to be relevant to emerging drug molecules and deliv- ery devices. Previous standards didn't necessarily take into account the unique containment needs of bio- logics or other large molecule drugs. Additionally, old standards didn't address the total drug containment and delivery system, but instead focused on individual components, such as stoppers and vials. It's a com- pletely different supply chain now, and the standards need to be updated to address the needs around current drug molecules and delivery systems as well as future therapeutic oferings. PMP: The presentation explores manual versus automated counting. How does a company decide? Riter: Deciding on the most appro- priate technology depends on what the company has established as its desired outcome and the accuracy of the soft- ware. Not all software is created equal. When you are looking at particles of diferent sizes, colors, and types, you have to ensure you have the right soft- ware to appropriately account for dif- ferent types of particles and materials. PMP: Should pharma companies ask their suppliers for guaranteed max- imum particulate counts and then ver- ify those counts upon receipt? Inline? During sampling? Polywacz: For products that are going to be directly introduced into their fill suite, the answer is yes—it is the responsibility of the supplier to prepare those products beforehand. That's why it's crucial to work col- laboratively throughout the process so that all parties understand the total particle burden across the supply chain and where the responsibility lies to ensure the end product is what is need- ed and expected. PMP: Andy also stated that pharma companies need to be aware of how their own processes contribute to par- ticles. What evaluations should they perform? Riter: We encourage pharma- ceutical companies to be aware of the inherent variability within their processes, as well as their range of capabilities. Additionally, it's important to have confidence in their data and the repeatability of acceptable outcomes, especially when it comes to particu- lates. And the data should encompass the entire supply chain. PMP: What control should they institute? Should there be ongoing s a m p l i n g a n d m o n i t o r i n g ? W h a t other steps should they take? Polywacz: Given the different areas of manufacturing within phar- maceutical companies, it's important to have ongoing monitoring, as well as a sound understanding of the fac- tors afecting the particle levels with- in their specific operations. Some of these factors may be seasonal, while others are related to inherent change. Monitoring and understanding where and when those shifts occur and how to mitigate them is critically impor- tant. PMP: Are particles and particulates the same? Polywacz: Yes. The two terms are used interchangeably. PMP: Any other advice for over- coming packaging challenges as they contribute to particles? Polywacz: When we work with our pharmaceutical partners, it always starts with the patient and their needs, and then we work back through the whole process from there. Whether it be the secondary packaging manufac- turer or our suppliers, we all need to understand the potential for particu- lates each step of the way before the drug product reaches a patient. At West, we serve as an advocate for our pharmaceutical partners among suppliers—ensuring that the end prod- uct is of the highest quality possible and meets the needs of the patients relying on these therapies. 0

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