Article CommentaryCommentary
Addressing Medical Device Extractables and Leachables via Non-Target Analysis (NTA); The Analytical Evaluation Threshold (AET) and Quantitation
Dennis Jenke, Piet Christiaens and Ted Heise
PDA Journal of Pharmaceutical Science and Technology January 2025, 79 (1) 98-113; DOI: https://doi.org/10.5731/pdajpst.2024.012945
Dennis Jenke
1Triad Scientific Solutions, LLC, Hawthorn Woods, IL;
Piet Christiaens
2Nelson Labs, Europe; and
Ted Heise
3Medical Engineering & Development Institute Incorporated

References
- 1.↵International Organization for Standardization, ISO 10993-18:2020 Biological Evaluation of Medical Devices—Part 18: Chemical Characterization of Medical Device Materials Within a Risk Management Process. ISO: Geneva, 2020.
- 2.↵PQRI Leachables and Extractables Working Group. Safety Thresholds and Best Practices for Extractables and Leachables in Orally Inhaled and Nasal Drug Products; 2006. https://pqri.org/wp-content/uploads/2015/08/pdf/LE_Recommendations_to_FDA_09-29-06.pdf
- 3.↵International Organization for Standardization, ISO/TR 21726:2019 Biological Evaluation of Medical Devices. Application of the Threshold of Toxicological Concern (TTC) for Assessing Biocompatibility of Medical Device Constituents. ISO: Geneva, 2019.
- 4.↵International Conference for Harmonisation, ICH M7(R2) Assessment and Control of DNA Reactive (Mutagenic) Impurities in Pharmaceuticals to Limit Potential Carcinogenic Risk. ICH: Geneva, 2023.
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In This Issue
PDA Journal of Pharmaceutical Science and Technology
Vol. 79, Issue 1
January/February 2025
Addressing Medical Device Extractables and Leachables via Non-Target Analysis (NTA); The Analytical Evaluation Threshold (AET) and Quantitation
Dennis Jenke, Piet Christiaens, Ted Heise
PDA Journal of Pharmaceutical Science and Technology Jan 2025, 79 (1) 98-113; DOI: 10.5731/pdajpst.2024.012945
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