A Risk-based Approach to Setting Sterile Filtration Bioburden Limits

Harry Yang; Na Li; Stephen Chang

doi:10.5731/pdajpst.2013.00942

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A Risk-based Approach to Setting Sterile Filtration Bioburden Limits

Harry Yang, Na Li and Stephen Chang

PDA Journal of Pharmaceutical Science and Technology November 2013, 67 (6) 601-609; DOI: https://doi.org/10.5731/pdajpst.2013.00942

Harry Yang

MedImmune LLC, One MedImmune Way, Gaithersburg, MD 20878

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For correspondence: YangH@MedImmune.com

Na Li

MedImmune LLC, One MedImmune Way, Gaithersburg, MD 20878

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Stephen Chang

MedImmune LLC, One MedImmune Way, Gaithersburg, MD 20878

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vol. 67 no. 6 601-609

DOI

https://doi.org/10.5731/pdajpst.2013.00942

PubMed

24265301

Published By

Parenteral Drug Association (PDA)

Print ISSN

1079-7440

Online ISSN

1948-2124

History

Published online November 21, 2013.

Author Information

Harry Yang*,
Na Li and
Stephen Chang

MedImmune LLC, One MedImmune Way, Gaithersburg, MD 20878

↵*Corresponding Author: Harry Yang MedImmune LLC, One MedImmune Way, Gaithersburg, MD 20878. YangH{at}MedImmune.com

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PDA Journal of Pharmaceutical Science and Technology

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A Risk-based Approach to Setting Sterile Filtration Bioburden Limits

Harry Yang, Na Li, Stephen Chang

PDA Journal of Pharmaceutical Science and Technology Nov 2013, 67 (6) 601-609; DOI: 10.5731/pdajpst.2013.00942

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A Risk-based Approach to Setting Sterile Filtration Bioburden Limits

Harry Yang, Na Li, Stephen Chang

PDA Journal of Pharmaceutical Science and Technology Nov 2013, 67 (6) 601-609; DOI: 10.5731/pdajpst.2013.00942

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Keywords

Batch size
Negative binomial distribution
Poisson distribution
Pre-filtration bioburden
Risk-based approach
Sterilizing grade filter

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