Development and Justification for Simulated Use Conditions for Leachables Analysis from Medical Devices

One of the most difficult aspects of chemical characterization for medical devices is the inability to exactly simulate biological use conditions. In chemical characterization of pharmaceutical packaging, a true leachables assessment can be performed by a direct analysis of the drug product. Unfortunately, there is no simple analytical solution which is a direct simulant for the biological environment of a medical device.

A similar problem sometimes exists for pharmaceutical packaging when a drug product matrix is so complex that it interferes with the analytical chemist’s ability to identify unknown leachables. In this case, the guidance documents have allowed for the application of a simulated drug matrix which is more analytically feasible. This can be reasonably done since the drug matrix chemistry is well understood.

For medical devices, this process is not as simple since the biological matrix is so complex. It is often speculated that the components present in blood such as proteins and phospholipids may result in enhanced extraction as compared to aqueous solutions such as saline. For these reasons, the industry has historically relied on water/alcohol mixtures as the go to method to enhance the hydrophobicity of the simulating solvent. Recently, a number of potential concerns have been raised about the use of binary solvent mixtures such as preferential absorption of the more hydrophobic component of the solvent by the medical device.

In this talk, we will review the issues related to the use of binary solvents as well as relay results showing a comparison of the extraction power of blood contrasted with saline and water/alcohol mixtures for a series of analytes relevant to blood contacting medical devices. Methods for confirming the absence of preferential absorption of the hydrophobic component of the binary solvent mixture will also be described.

Key Learning Objectives:

• What is the purpose of simulating solvents in medical device leachables assessments?
• How can simulating conditions be justified?
• Results from a study of simulating conditions as compared to analysis out of whole blood.

Who Should Attend:

• E&L analysts and Lab managers
• Researchers interested in E&L Testing in Food/Pharma/Medical Device/Consumer Products/Polymer Manufacturing/CRO’s/CMO’s and other
• Analysts performing untargeted analyses including drug impurity profiling
• Quality Assurance experts in the above industries

Presenter: Dr. Mark Jordi (President and CEO, Jordi Labs)

Presenter: Catherine Dold (Health & Environment Writer, C&EN Media Group)