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Simulated Leaching (Migration) Study for a Model Container-closure System Applicable to Parenteral and Ophthalmic Drug Products (PODPs)

Dennis Jenke, Thomas Egert, Alan Hendricker, James Castner, Thomas Feinberg, Christopher Houston, Desmond Hunt, Michael Lynch, Kumudini Nicholas, Daniel L Norwood, Diane Paskiet, Michael Ruberto, Edward J Smith and Frank Holcomb
PDA Journal of Pharmaceutical Science and Technology December 2016, pdajpst.2016.007229; DOI: https://doi.org/10.5731/pdajpst.2016.007229
Dennis Jenke
1 Baxter Healthcare Corporation;
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  • For correspondence: dennis_jenke@baxter.com
Thomas Egert
2 Boehringer Ingelheim;
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  • For correspondence: thomas.egert@boehringer-ingelheim.com
Alan Hendricker
3 Becton Dickinson;
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James Castner
4 Pharma Interface Analysis, LLC;
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  • For correspondence: jcastner410@gmail.com
Thomas Feinberg
5 SCIO Analytical;
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  • For correspondence: tom_feinberg@scioanalytical.com
Christopher Houston
6 iuvo BioScience;
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Desmond Hunt
7 United States Pharmacopeial Convention;
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  • For correspondence: dgh@usp.org
Michael Lynch
8 Pfizer;
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  • For correspondence: michael.p.lynch@pfizer.com
Kumudini Nicholas
9 Health Canada;
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  • For correspondence: kumudini.nicholas@hc-sc.gc.ca
Daniel L Norwood
10 SCIO Analytical Consulting;
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  • For correspondence: daniel_norwood@scioanalytical.com
Diane Paskiet
11 West Pharmaceutical Services;
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  • For correspondence: diane.paskiet@westpharma.com
Michael Ruberto
12 Material Needs Consulting, LLC;
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  • For correspondence: michael.ruberto@materialneedsconsulting.com
Edward J Smith
13 PACKAGING SCIENCE RESOURCES;
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  • For correspondence: esmithpkg@msn.com
Frank Holcomb
14 FDA
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  • For correspondence: frank.holcombejr@fda.hhs.gov
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Article Information

pdajpst.2016.007229
DOI 
https://doi.org/10.5731/pdajpst.2016.007229
PubMed 
27974627

Published By 
Parenteral Drug Association (PDA)
Print ISSN 
1079-7440
Online ISSN 
1948-2124
History 
  • Received September 2, 2016
  • Accepted September 6, 2016
  • Published online December 14, 2016.

Article Versions

  • You are currently viewing a previous version of this article (December 14, 2016 - 05:03).
  • View the most recent version of this article
Copyright & Usage 
Copyright © 2016, Parenteral Drug Association

Author Information

  1. Dennis Jenke1,15 (dennis_jenke{at}baxter.com),
  2. Thomas Egert2 (thomas.egert{at}boehringer-ingelheim.com),
  3. Alan Hendricker3 (alan_hendricker{at}bd.com),
  4. James Castner4 (jcastner410{at}gmail.com),
  5. Thomas Feinberg5 (tom_feinberg{at}scioanalytical.com),
  6. Christopher Houston6,
  7. Desmond Hunt7 (dgh{at}usp.org),
  8. Michael Lynch8 (michael.p.lynch{at}pfizer.com),
  9. Kumudini Nicholas9 (kumudini.nicholas{at}hc-sc.gc.ca),
  10. Daniel L Norwood10 (daniel_norwood{at}scioanalytical.com),
  11. Diane Paskiet11 (diane.paskiet{at}westpharma.com),
  12. Michael Ruberto12 (michael.ruberto{at}materialneedsconsulting.com),
  13. Edward J Smith13 (esmithpkg{at}msn.com) and
  14. Frank Holcomb14 (frank.holcombejr{at}fda.hhs.gov)
  1. 1 Baxter Healthcare Corporation;
  2. 2 Boehringer Ingelheim;
  3. 3 Becton Dickinson;
  4. 4 Pharma Interface Analysis, LLC;
  5. 5 SCIO Analytical;
  6. 6 iuvo BioScience;
  7. 7 United States Pharmacopeial Convention;
  8. 8 Pfizer;
  9. 9 Health Canada;
  10. 10 SCIO Analytical Consulting;
  11. 11 West Pharmaceutical Services;
  12. 12 Material Needs Consulting, LLC;
  13. 13 PACKAGING SCIENCE RESOURCES;
  14. 14 FDA
  1. ↵* Corresponding author; email: dennis_jenke{at}baxter.com

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PDA Journal of Pharmaceutical Science and Technology: 79 (3)
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Simulated Leaching (Migration) Study for a Model Container-closure System Applicable to Parenteral and Ophthalmic Drug Products (PODPs)
Dennis Jenke, Thomas Egert, Alan Hendricker, James Castner, Thomas Feinberg, Christopher Houston, Desmond Hunt, Michael Lynch, Kumudini Nicholas, Daniel L Norwood, Diane Paskiet, Michael Ruberto, Edward J Smith, Frank Holcomb
PDA Journal of Pharmaceutical Science and Technology Dec 2016, pdajpst.2016.007229; DOI: 10.5731/pdajpst.2016.007229

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Simulated Leaching (Migration) Study for a Model Container-closure System Applicable to Parenteral and Ophthalmic Drug Products (PODPs)
Dennis Jenke, Thomas Egert, Alan Hendricker, James Castner, Thomas Feinberg, Christopher Houston, Desmond Hunt, Michael Lynch, Kumudini Nicholas, Daniel L Norwood, Diane Paskiet, Michael Ruberto, Edward J Smith, Frank Holcomb
PDA Journal of Pharmaceutical Science and Technology Dec 2016, pdajpst.2016.007229; DOI: 10.5731/pdajpst.2016.007229
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Keywords

  • PODP
  • Extractables
  • Leachables
  • migration study
  • parenteral and ophthalmic drug products
  • simulation study

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