Single-Use Container Closure Integrity I: Using Microbial Ingress Test Method to Determine the Maximum Allowable Leakage Limit (MALL)

Saeedeh Aliaskarisohi; Marc Hogreve; Carole Langlois; Magali Barbaroux; Jean-Marc Cappia; Marie-Christine Menier

doi:10.5731/pdajpst.2018.009688

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Single-Use Container Closure Integrity I: Using Microbial Ingress Test Method to Determine the Maximum Allowable Leakage Limit (MALL)

Saeedeh Aliaskarisohi, Marc Hogreve, Carole Langlois, Magali Barbaroux, Jean-Marc Cappia and Marie-Christine Menier

PDA Journal of Pharmaceutical Science and Technology April 2019, pdajpst.2018.009688; DOI: https://doi.org/10.5731/pdajpst.2018.009688

Saeedeh Aliaskarisohi

1 Sartorius Stedim Biotch;

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For correspondence: saaedeh.aliaskarisohi@sartorius.com

Marc Hogreve

2 Sartorius Stedim Biotech

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Carole Langlois

2 Sartorius Stedim Biotech

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Magali Barbaroux

2 Sartorius Stedim Biotech

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Jean-Marc Cappia

2 Sartorius Stedim Biotech

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Marie-Christine Menier

2 Sartorius Stedim Biotech

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pdajpst.2018.009688

DOI

https://doi.org/10.5731/pdajpst.2018.009688

PubMed

31004038

Published By

Parenteral Drug Association (PDA)

Print ISSN

1079-7440

Online ISSN

1948-2124

History

Received November 13, 2018
Accepted April 10, 2019
Published online April 19, 2019.

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Author Information

Saeedeh Aliaskarisohi1,3 (saaedeh.aliaskarisohi{at}sartorius.com),
Marc Hogreve2,
Carole Langlois2,
Magali Barbaroux2,
Jean-Marc Cappia2 and
Marie-Christine Menier2

¹ Sartorius Stedim Biotch;
² Sartorius Stedim Biotech

↵* Corresponding author; email: saaedeh.aliaskarisohi{at}sartorius.com

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Single-Use Container Closure Integrity I: Using Microbial Ingress Test Method to Determine the Maximum Allowable Leakage Limit (MALL)

Saeedeh Aliaskarisohi, Marc Hogreve, Carole Langlois, Magali Barbaroux, Jean-Marc Cappia, Marie-Christine Menier

PDA Journal of Pharmaceutical Science and Technology Apr 2019, pdajpst.2018.009688; DOI: 10.5731/pdajpst.2018.009688

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Single-Use Container Closure Integrity I: Using Microbial Ingress Test Method to Determine the Maximum Allowable Leakage Limit (MALL)

Saeedeh Aliaskarisohi, Marc Hogreve, Carole Langlois, Magali Barbaroux, Jean-Marc Cappia, Marie-Christine Menier

PDA Journal of Pharmaceutical Science and Technology Apr 2019, pdajpst.2018.009688; DOI: 10.5731/pdajpst.2018.009688

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Keywords

Container clouser integrity (CCI)
maximum allowable leakage limit (MALL)
Microbial container clouser integrity (mCCI)
microbial ingress testing
Single-use system (SUS)

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