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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;
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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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References

  1. 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. 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. 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. 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.
  5. 5.↵
    1. Jenke D.
    Insights into Practical Challenges Associated with Extractables Testing of Medical Devices. BioPharma Asia. 2023, 12 (5), 18–25.
    OpenUrl
  6. 6.↵
    1. Jenke D.,
    2. Heise T.
    The Implications of Chromatographically Screening Medical Products for Organic Leachables Down to the Analytical Evaluation Threshold Adjusted for Response Factor Variation. PDA J. Pharm. Sci. Technol. 2021, 75 (3), 273–288.
    OpenUrlAbstract/FREE Full Text
  7. 7.↵
    1. Jenke D.,
    2. Christiaens P.,
    3. Heise T.
    Identification and Quantification of Medical Device Extractables and Leachables via Non-Target Analysis (NTA); Analytical Uncertainty. J. Pharm. Biomed. Anal. 2024, 241, 115985.
    OpenUrlPubMed
  8. 8.↵
    1. Sussman E. M.,
    2. Oktem B.,
    3. Isayeva I. S.,
    4. Liu J.,
    5. Wickramasekara S.,
    6. Chandrasekar V.,
    7. Nahan K.,
    8. Shin H. Y.,
    9. Zheng J.
    Chemical Characterization and Non-Targeted Analysis of Medical Device Extracts: A Review of Current Approaches, Gaps, and Emerging Practices. ACS Biomater. Sci. Eng. 2022, 8 (3), 939–963.
    OpenUrlPubMed
  9. 9.↵
    1. Jenke D.,
    2. Christiaens P.,
    3. Verlinde P.,
    4. Baeten J.,
    5. Beusen J.-M.
    Is Retention Time and/or Structure Matching a Solution to the Challenge of Providing Quantitative Data When Screening for Extractables and Leachables by GC/MS? PDA J. Pharm. Sci. Technol. 2022, 76 (3), 236–247.
    OpenUrlAbstract/FREE Full Text
  10. 10.↵
    1. Jenke D.
    Accurate or Protective: What is the Goal of Non-Targeted Extractables and Leachables Quantification and Identification? PDA J. Pharm. Sci. Technol. 2024, 78 (3), 358–366.
    OpenUrlAbstract/FREE Full Text
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PDA Journal of Pharmaceutical Science and Technology: 79 (1)
PDA Journal of Pharmaceutical Science and Technology
Vol. 79, Issue 1
January/February 2025
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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

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  • Extractables and leachables
  • Analytical uncertainty
  • Analytical Evaluation Threshold
  • Quantification

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