Feasibility of Using Fluorescence Spectrophotometry to Develop a Sensitive Dye Immersion Method for Container Closure Integrity Testing of Prefilled Syringes

Xujin Lu; David K. Lloyd; Steven E. Klohr

doi:10.5731/pdajpst.2015.006015

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Feasibility of Using Fluorescence Spectrophotometry to Develop a Sensitive Dye Immersion Method for Container Closure Integrity Testing of Prefilled Syringes

Xujin Lu, David K. Lloyd and Steven E. Klohr

PDA Journal of Pharmaceutical Science and Technology January 2016, 70 (1) 39-50; DOI: https://doi.org/10.5731/pdajpst.2015.006015

Xujin Lu

Analytical and Bioanalytical Development, Research & Development, Bristol-Myers Squibb Company, New Brunswick, NJ

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For correspondence: xujin.lu@bms.com

David K. Lloyd

Analytical and Bioanalytical Development, Research & Development, Bristol-Myers Squibb Company, New Brunswick, NJ

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Steven E. Klohr

Analytical and Bioanalytical Development, Research & Development, Bristol-Myers Squibb Company, New Brunswick, NJ

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vol. 70 no. 1 39-50

DOI

https://doi.org/10.5731/pdajpst.2015.006015

PubMed

26889055

Published By

Parenteral Drug Association (PDA)

Print ISSN

1079-7440

Online ISSN

1948-2124

History

Published online February 16, 2016.

Author Information

Xujin Lu*,
David K. Lloyd and
Steven E. Klohr

Analytical and Bioanalytical Development, Research & Development, Bristol-Myers Squibb Company, New Brunswick, NJ

↵* Corresponding Author: Xujin Lu, Analytical and Bioanalytical Development, Research & Development, Bristol-Myers Squibb Company, New Brunswick, NJ 08903; e-mail: xujin.lu{at}bms.com

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Feasibility of Using Fluorescence Spectrophotometry to Develop a Sensitive Dye Immersion Method for Container Closure Integrity Testing of Prefilled Syringes

Xujin Lu, David K. Lloyd, Steven E. Klohr

PDA Journal of Pharmaceutical Science and Technology Jan 2016, 70 (1) 39-50; DOI: 10.5731/pdajpst.2015.006015

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Feasibility of Using Fluorescence Spectrophotometry to Develop a Sensitive Dye Immersion Method for Container Closure Integrity Testing of Prefilled Syringes

Xujin Lu, David K. Lloyd, Steven E. Klohr

PDA Journal of Pharmaceutical Science and Technology Jan 2016, 70 (1) 39-50; DOI: 10.5731/pdajpst.2015.006015

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Container Closure Integrity Testing--Practical Aspects and Approaches in the Pharmaceutical Industry

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Keywords

Prefilled syringes
Container closure integrity
Dye ingress
Fluorescence detection
UV detection

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Feasibility of Using Fluorescence Spectrophotometry to Develop a Sensitive Dye Immersion Method for Container Closure Integrity Testing of Prefilled Syringes

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