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PDA Journal of Pharmaceutical Science and Technology

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Research ArticleTechnology/Application

Validation of the BacT/ALERT® 3D System for Rapid Sterility Testing of Biopharmaceutical Samples

Luis Jimenez, Narendra Rana, Joseph Amalraj, Kimberly Walker and Kasey Travers
PDA Journal of Pharmaceutical Science and Technology January 2012, 66 (1) 38-54; DOI: https://doi.org/10.5731/pdajpst.2012.00790
Luis Jimenez
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  • For correspondence: papojbmicro@gmail.com
Narendra Rana
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Joseph Amalraj
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Kimberly Walker
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Kasey Travers
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Article Information

vol. 66 no. 1 38-54
DOI 
https://doi.org/10.5731/pdajpst.2012.00790
PubMed 
22307661

Published By 
Parenteral Drug Association (PDA)
Print ISSN 
1079-7440
Online ISSN 
1948-2124
History 
  • Published online February 2, 2012.

Copyright & Usage 
© PDA, Inc. 2012

Author Information

  1. Luis Jimenez*,
  2. Narendra Rana,
  3. Joseph Amalraj,
  4. Kimberly Walker and
  5. Kasey Travers
  1. Microbiology Laboratory, Immunomedics Inc.
  1. ↵* Corresponding author: Luis Jimenez, Microbiology Laboratory, Immunomedics Inc., 300 American Road, Morris Plains, New Jersey 07950. Telephone: 201-446-7143. Email: papojbmicro{at}gmail.com.
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PDA Journal of Pharmaceutical Science and Technology: 66 (1)
PDA Journal of Pharmaceutical Science and Technology
Vol. 66, Issue 1
January/February 2012
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Validation of the BacT/ALERT® 3D System for Rapid Sterility Testing of Biopharmaceutical Samples
Luis Jimenez, Narendra Rana, Joseph Amalraj, Kimberly Walker, Kasey Travers
PDA Journal of Pharmaceutical Science and Technology Jan 2012, 66 (1) 38-54; DOI: 10.5731/pdajpst.2012.00790

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Validation of the BacT/ALERT® 3D System for Rapid Sterility Testing of Biopharmaceutical Samples
Luis Jimenez, Narendra Rana, Joseph Amalraj, Kimberly Walker, Kasey Travers
PDA Journal of Pharmaceutical Science and Technology Jan 2012, 66 (1) 38-54; DOI: 10.5731/pdajpst.2012.00790
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  • Sterility Testing of Injectable Products: Evaluation of the Growth-based BacT/ALERT(R) 3D™ Dual T Culture System
  • Polymerase Chain Reaction/Rapid Methods Are Gaining a Foothold in Developing Countries
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  • Using Sensitivity Analysis to Simplify the Virus Safety Factor Calculation in the Manufacture of Biopharmaceuticals
  • Rapid Sterility Test Systems in the Pharmaceutical Industry: Applying a Structured Approach to their Evaluation, Validation and Global Implementation
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