Addressing Medical Device Extractables and Leachables via Non-Target Analysis (NTA); The Analytical Evaluation Threshold (AET) and Quantitation

Dennis Jenke; Piet Christiaens; Ted Heise

doi:10.5731/pdajpst.2024.012945

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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;

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For correspondence: dennisjenke@triadscientificsolutions.com

Piet Christiaens

2Nelson Labs, Europe; and

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Ted Heise

3Medical Engineering & Development Institute Incorporated

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vol. 79 no. 1 98-113

DOI

https://doi.org/10.5731/pdajpst.2024.012945

PubMed

39730201

Published By

Parenteral Drug Association (PDA)

Print ISSN

1079-7440

Online ISSN

1948-2124

History

Published online March 3, 2025.

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previous version (December 27, 2024 - 10:20).
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Dennis Jenke¹,*,
Piet Christiaens² and
Ted Heise³

¹Triad Scientific Solutions, LLC, Hawthorn Woods, IL;
²Nelson Labs, Europe; and
³Medical Engineering & Development Institute Incorporated

↵*Corresponding author: Triad Scientific Solutions, LLC, 181 Peregrine Lane, Hawthorn Woods, IL 60047; E-mail: dennisjenke{at}triadscientificsolutions.com

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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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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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Keywords

Medical devices
Extractables and leachables
Analytical uncertainty
Analytical Evaluation Threshold
Quantification

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