Best Practices for Conducting Extractable and Leachable Studies


Regulatory agencies expect that any container closure systems or components utilized in manufacturing the drug product do not adulterate the product. Extractable studies are performed to evaluate the potential for various chemicals to migrate from container closure or manufacturing systems into pharmaceutical products. Appropriately designed extractables studies provide relevant and meaningful data, allowing for a detailed risk assessment.

Several different extraction solutions and analytical techniques may be employed to screen the components of interest for extractable compounds. Some solvent/product matrices may interfere with the testing and present challenges for the analytical techniques performed. Care must be taken in evaluating these matrices to ensure that potential extractable compounds are capable of being observed.

Data generated from an extractable study should be evaluated to determine the toxicological concern of the extracted compounds. Compounds are assessed using a step-wise approach from a definition of threshold to the evaluation of tolerable exposure.

Establishing the effectiveness of disinfectants is an important component of a facility cleaning and environmental monitoring program, though the variables related to disinfection of surfaces, along with the time and labor required to conduct these studies, can make the process complex.

During this presentation, you will learn:
  • Strategies for establishing an extractables study design
  • Risk assessment based on product type
  • Use of various analytical techniques and their benefits and disadvantages
  • Tools utilized to handle difficult sample matrices
  • Tools to handle Threshold of Toxicological Concern (TTC)
  • Data sources useful for toxicological evaluation
  • Tools to evaluate Tolerable Intake (TI) and Tolerable Exposure (TE)
  • Design of studies to monitor leachable compounds
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