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
Niamh O'Dwyer
Pfizer
Jeremy Bollinger
Biogen
Alan Johnson
Amgen
Brian Goss
Lilly
Ned Wyman
AstraZeneca
Adeyma Arroyo
Genentech/Roche
Joseph Wood
Genentech/Roche
Derek Willison-Parry
BPOG

Reference
- 1.↵ASME BPE (Bioprocessing Equipment Standard) 2014 a. Nonmadatory Appendix J. Standard Process Test Conditions (SPTC) for Seal Performance Evaluation b. ASME BPE 2014 Part SG. Sealing Component c. Other applicable sections.
- 2.↵21 CFR 177, USP CLASS VI Part 87 and 88, Leachables and Extractables.
- 3.↵Bioprocess Institute (EPDM and Silicone Testing Reports).
- 4.↵ASTM D1418—Standard Practice for Rubber and Rubber Lattices.
- 5.↵PDA Technical Report No. 49. Points To Consider for Biotechnology Cleaning Validation.
- 6.↵
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- Romero J.,
- Runkle S.,
- Carolan C.,
- Mott A.,
- Clark M. E.,
- Wyman E.,
- Rasmi M.,
- Donat S.,
- Bellorado K.
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- Mott A.,
- Henry B.,
- Wyman E.,
- Bellorado K.,
- Blümel M.,
- Parks M.,
- Hayes R.,
- Runkle S.,
- Luo W.
- 8.
- Lynch R.,
- Barabani D.,
- Bellorado K.,
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In This Issue
PDA Journal of Pharmaceutical Science and Technology
Vol. 72, Issue 1
January/February 2018
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
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
Jump to section
- 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
- Figures & Data
- References
- Info & Metrics
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