A significant part of Extractable & Leachable testing is to determine if a container/closure/device/ material/etc is suitable for use through an evaluation of toxicological impact. That evaluation includes:

  1. The evaluation of Chemical compounds/elements that may be delivered to the patient,
  2. Through understanding the product’s clinical application and the patient population affected, determine the appropriate Toxicological Risk Assessment (TRA) Methodology, &
  3. Perform the TRA to determine if the product is safe for its intended use or if either product changes or further evaluations are needed.

Whitehouse Labs, a division of AMRI, offers toxicological risk assessment services to evaluate adverse risks to patients’ health by assessing the leachates of a system against information on in vitro tests, animal studies, computational methods and predictive means. The information obtained allows our clients to mitigate risk during product development, and demonstrate safety in regulatory documentation. The necessity to perform additional testing can help determined if the chemical profile assessed poses a risk.

Our Toxicology Risk Assessment (TRA) Services include:

  • Estimation of risk from extractable and leachable compounds from container/closure and/or drug delivery systems
  • Determination of PDE’s, ADI’s, and Margins of Safety from process impurities, residual solvents, degradants and other source materials
  • Packaging compliance guidance/ Product Labelling Reviews
  • Determination of Biocompatibility and/or Suitability
  • Assess material vendor/supplier/manufacturer changes (Change control)
  • Consideration of potential for misuse of the product (failure analysis)

Please contact us for more information, wlcontainers@amriglobal.com.