The main objective of extractable and leachable testing is to identify and quantify any potentially harmful or reactive substances that could leach into the parenteral drug and pose a risk to patient safety. These substances can come from various sources, including container closures (e.g., rubber stoppers, plastic materials), delivery systems (e.g., infusion bags, syringes), or manufacturing processes (e.g., residues from cleaning agents, solvents).
The testing process typically involves subjecting the drug container, closure system, or delivery device to controlled extraction conditions to simulate various scenarios it may encounter during storage, transportation, or use. The extracted samples are then analyzed using a variety of analytical testing methods such as gas chromatography (GC), liquid chromatography (LC), mass spectrometry (MS), and spectroscopy, among others.
During this webinar, hosted by Gateway Analytical, an Aptar Pharma company, the speakers extensively discussed the significance of extractable and leachable testing in safeguarding the effectiveness and safety of parenteral drugs. They also explored various facets of study design, such as regulatory norms, best practices, equipment, sample preparation, storage conditions, and interpretation of results specific to products and applications. The speakers also shared a case study that emphasized the collaborative nature of extractables, leachables, and stability studies in conducting a successful E&L study.