The universe of extractables is extremely diverse, encompassing a wide variety of materials used in the construction of container/closure systems and medical devices. Each material has its unique formulation, polymerization, processing, and manufacturing characteristics, which contribute to its extractables profile. This presentation will provide an in-depth overview of the most common materials used in these systems and the main classes of compounds often detected in extractable studies.
Materials used in container/closure systems and medical devices typically have an impurities profile composed of compounds intentionally added to enhance performance, protect the material during production, or extend its life cycle. These polymer additives include antioxidants, slip agents, acid scavengers, clarifying/nucleating agents, colorants, UV stabilizers, adhesives, and more. These additives are critical for the functionality and durability of the materials.
In addition to intentionally added compounds, materials often contain a longer list of unintentional compounds introduced during the production process or formed as a result of aging. Examples of these compounds include solvent residues, cleaning residues, catalyst residues, oxidation/degradation products of the polymer, and degradation products of the polymer additives. Understanding these unintentional compounds is crucial as they can significantly impact the extractables profile.
The presentation will explain why these compounds are present, their functions, and how they are formed. By examining the composition of materials and their impact on the extractables profile, participants will gain a comprehensive understanding of the complexities involved in extractables studies. This knowledge is essential for performing a proper evaluation of data and conducting subsequent risk assessments.
Attendees will learn about the importance of understanding the composition of materials and the various factors that influence their extractables profile. This insight will help professionals in the medical device and pharmaceutical industries to better manage the risks associated with extractables, ensuring the safety and efficacy of their products.