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Case ReportCase Studies

Investigation of Air–Liquid Interface Rings in Buffer Preparation Vessels: the Role of Slip Agents

Ting Shi, Wei Ding, Donald W. Kessler, Nuria De Mas, Douglas G. Weaver, Charles Pathirana, Russell D. Martin, Nancy A. Mackin, Michael Casati, Scott A. Miller and Itzcoatl A. Pla
PDA Journal of Pharmaceutical Science and Technology May 2016, 70 (3) 272-281; DOI: https://doi.org/10.5731/pdajpst.2015.005736
Ting Shi
1Manufacturing Sciences & Technology, Bristol-Myers Squibb, Devens, MA;
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  • For correspondence: ting.shi@bms.com
Wei Ding
2Analytical and Bioanalytical Development, Bristol-Myers Squibb, New Brunswick, NJ;
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Donald W. Kessler
1Manufacturing Sciences & Technology, Bristol-Myers Squibb, Devens, MA;
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Nuria De Mas
1Manufacturing Sciences & Technology, Bristol-Myers Squibb, Devens, MA;
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Douglas G. Weaver
3Global Quality Operations, Bristol-Myers Squibb, East Syracuse, NY;
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Charles Pathirana
2Analytical and Bioanalytical Development, Bristol-Myers Squibb, New Brunswick, NJ;
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Russell D. Martin
3Global Quality Operations, Bristol-Myers Squibb, East Syracuse, NY;
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Nancy A. Mackin
4Manufacturing Sciences & Technology, Bristol-Myers Squibb, East Syracuse, NY; and
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Michael Casati
5Global Procurement Biologics Sourcing, Bristol-Myers Squibb, Devens, MA
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Scott A. Miller
2Analytical and Bioanalytical Development, Bristol-Myers Squibb, New Brunswick, NJ;
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Itzcoatl A. Pla
1Manufacturing Sciences & Technology, Bristol-Myers Squibb, Devens, MA;
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Article Information

vol. 70 no. 3 272-281
DOI 
https://doi.org/10.5731/pdajpst.2015.005736
PubMed 
26797969

Published By 
Parenteral Drug Association (PDA)
Print ISSN 
1079-7440
Online ISSN 
1948-2124
History 
  • Published online May 31, 2016.

Article Versions

  • previous version (January 21, 2016 - 17:53).
  • You are viewing the most recent version of this article.
Copyright & Usage 
© PDA, Inc. 2016

Author Information

  1. Ting Shi1,*,
  2. Wei Ding2,
  3. Donald W. Kessler1,
  4. Nuria De Mas1,
  5. Douglas G. Weaver3,
  6. Charles Pathirana2,
  7. Russell D. Martin3,
  8. Nancy A. Mackin4,
  9. Michael Casati5,
  10. Scott A. Miller2 and
  11. Itzcoatl A. Pla1
  1. 1Manufacturing Sciences & Technology, Bristol-Myers Squibb, Devens, MA;
  2. 2Analytical and Bioanalytical Development, Bristol-Myers Squibb, New Brunswick, NJ;
  3. 3Global Quality Operations, Bristol-Myers Squibb, East Syracuse, NY;
  4. 4Manufacturing Sciences & Technology, Bristol-Myers Squibb, East Syracuse, NY; and
  5. 5Global Procurement Biologics Sourcing, Bristol-Myers Squibb, Devens, MA
  1. ↵* Corresponding Author: Ting Shi, Manufacturing Sciences & Technology, Bristol-Myers Squibb, Devens, MA 01434; Telephone: 978-784-6350; e-mail: ting.shi@bms.com
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PDA Journal of Pharmaceutical Science and Technology: 70 (3)
PDA Journal of Pharmaceutical Science and Technology
Vol. 70, Issue 3
May/June 2016
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Investigation of Air–Liquid Interface Rings in Buffer Preparation Vessels: the Role of Slip Agents
Ting Shi, Wei Ding, Donald W. Kessler, Nuria De Mas, Douglas G. Weaver, Charles Pathirana, Russell D. Martin, Nancy A. Mackin, Michael Casati, Scott A. Miller, Itzcoatl A. Pla
PDA Journal of Pharmaceutical Science and Technology May 2016, 70 (3) 272-281; DOI: 10.5731/pdajpst.2015.005736
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Keywords

  • Cleaning validation
  • erucamide
  • raw material
  • slip agent
  • leachable

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Investigation of Air–Liquid Interface Rings in Buffer Preparation Vessels: the Role of Slip Agents
Ting Shi, Wei Ding, Donald W. Kessler, Nuria De Mas, Douglas G. Weaver, Charles Pathirana, Russell D. Martin, Nancy A. Mackin, Michael Casati, Scott A. Miller, Itzcoatl A. Pla
PDA Journal of Pharmaceutical Science and Technology May 2016, 70 (3) 272-281; DOI: 10.5731/pdajpst.2015.005736

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