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Article CommentaryCommentary

Elastomer Change Out—Justification for Minimizing the Removal of Elastomers To Prevent Cross-Contamination in a Multiproduct Facility

Michael Parks, Niamh O'Dwyer, Jeremy Bollinger, Alan Johnson, Brian Goss, Ned Wyman, Adeyma Arroyo, Joseph Wood and Derek Willison-Parry
PDA Journal of Pharmaceutical Science and Technology January 2018, 72 (1) 81-90; DOI: https://doi.org/10.5731/pdajpst.2016.007484
Michael Parks
Pfizer
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Niamh O'Dwyer
Pfizer
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Jeremy Bollinger
Biogen
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Alan Johnson
Amgen
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Brian Goss
Lilly
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Ned Wyman
AstraZeneca
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Adeyma Arroyo
Genentech/Roche
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Joseph Wood
Genentech/Roche
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Derek Willison-Parry
BPOG
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  • For correspondence: derek@biophorum.com
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Article Information

vol. 72 no. 1 81-90
DOI 
https://doi.org/10.5731/pdajpst.2016.007484
PubMed 
28928292

Published By 
Parenteral Drug Association (PDA)
Print ISSN 
1079-7440
Online ISSN 
1948-2124
History 
  • Published online January 30, 2018.

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  • previous version (September 19, 2017 - 05:22).
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© PDA, Inc. 2018

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PDA Journal of Pharmaceutical Science and Technology: 72 (1)
PDA Journal of Pharmaceutical Science and Technology
Vol. 72, Issue 1
January/February 2018
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Elastomer Change Out—Justification for Minimizing the Removal of Elastomers To Prevent Cross-Contamination in a Multiproduct Facility
Michael Parks, Niamh O'Dwyer, Jeremy Bollinger, Alan Johnson, Brian Goss, Ned Wyman, Adeyma Arroyo, Joseph Wood, Derek Willison-Parry
PDA Journal of Pharmaceutical Science and Technology Jan 2018, 72 (1) 81-90; DOI: 10.5731/pdajpst.2016.007484

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Elastomer Change Out—Justification for Minimizing the Removal of Elastomers To Prevent Cross-Contamination in a Multiproduct Facility
Michael Parks, Niamh O'Dwyer, Jeremy Bollinger, Alan Johnson, Brian Goss, Ned Wyman, Adeyma Arroyo, Joseph Wood, Derek Willison-Parry
PDA Journal of Pharmaceutical Science and Technology Jan 2018, 72 (1) 81-90; DOI: 10.5731/pdajpst.2016.007484
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  • Article
    • Introduction
    • Design of Process Equipment and Piping Systems
    • CIP Equipment and Cycle Design
    • Validation of Equipment, Cleaning Cycles, and Procedures
    • Cleanability/Small-Scale Studies for Product Understanding
    • Elastomer Reliability and Replacement
    • Regulatory Guidance
    • Changeover Best Practices and Risk Assessment
    • Company Changeover Practices and Data
    • Conflicts of Interest Declaration
    • Reference
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