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Andy and Jennifer will present, “Particles Causing End of Line Rejects and Drug Product Recalls: Overcoming Packaging Challenges and Need for Adequate Controls,” at the conference. The session is designed to provide insight into the various sources, causes and concern for particulates from primary and secondary packaging components.
Particles may originate from multiple sources throughout the lifecycle of a pharmaceutical product. Various types and sizes of particles can occur which can be foreign or extrinsic to the process, intrinsic (that is, from within the product or process such as product contact materials), or inherent , which is known to be associated with specific products. Particulates can cause unintended changes to the finished pharmaceutical resulting in potential delays to market, not to mention the risk of costly recalls and shortages. The pharmaceutical ingredients and stability issues can contribute to the particle load as does the environment and manufacturing equipment but it is a well-known fact that materials used in primary and secondary packaging components are often identified. Component manufacturers are tasked with minimizing the particulate load to reduce the contribution to the finished drug product.
Join Andy and Jennifer at Interphex to learn more.