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Single-Use System Integrity I: Using a Microbial Ingress Test Method to Determine the Maximum Allowable Leakage Limit (MALL)
Saeedeh Aliaskarisohi, Marc Hogreve, Carole Langlois, Jonathan Cutting, Magali Barbaroux, Jean-Marc Cappia and Marie-Christine Menier
PDA Journal of Pharmaceutical Science and Technology September 2019, 73 (5) 459-469; DOI: https://doi.org/10.5731/pdajpst.2018.009688
Saeedeh Aliaskarisohi
1R&D, Sartorius Stedim Biotech GmbH, Goettingen, Germany;
Marc Hogreve
1R&D, Sartorius Stedim Biotech GmbH, Goettingen, Germany;
Carole Langlois
2Sartorius Stedim Biotech FMT SAS, Aubagne, France; and
Jonathan Cutting
3R&D, Sartorius Stedim Inc, Bohemia, NY
Magali Barbaroux
2Sartorius Stedim Biotech FMT SAS, Aubagne, France; and
Jean-Marc Cappia
2Sartorius Stedim Biotech FMT SAS, Aubagne, France; and
Marie-Christine Menier
2Sartorius Stedim Biotech FMT SAS, Aubagne, France; and

References
- 1.↵Council of Europe; Methods of Preparing Sterile Products. In European Pharmacopoeia (Ph. Eur.), 8th ed.; Council of Europe: Strasbourg, France, 2014; Chapter 5.1.1.
- 2.↵European Commission, Annex I-Manufacture of Sterile Medicinal Products. In EudraLex—The Rules Governing Medicinal Products in the European Union, Volume 4: Good Manufacturing Practice for Medicinal Products for Human and Veterinary Use; European Commission: Brussels, Belgium, 2010.
- 3.↵U.S. Food and Drug Administration, Guidance for Industry: Container and Closure System Integrity Testing In Lieu of Sterility Testing As a Component of Stability Protocol for Sterile Products. U.S. Department of Health and Human Services: Rockville, MD, 2008.
- 4.↵
- Chen C.,
- Harte B.,
- Lai C.,
- Pestka J.,
- Henyon D.
- 5.↵
- Kirsch L. E.,
- Nguyen L.,
- Moeckly C. S.
- 6.↵
- Nguyen L. T.,
- Muangsiri W.,
- Schiere R.,
- Guazzo D. K.,
- Kirsch L. E.
- 7.↵
- Burell L. S.,
- Carver M. W.,
- DeMuth G. E.,
- Lambert W. J.
- 8.↵
- Gilchrist J. E.,
- Rhea U. S.,
- Dickerson R. W.,
- Campbell J. E.
- 9.↵
- 10.↵
- Gilchrist J. E.,
- Shah D. B.,
- Radle D. C.,
- Dickerson R. W.
- 11.↵
- Keller S. W.,
- Marcy J. E.,
- Blakistone B. A.,
- Lacy G. H.,
- Hackney C. R.,
- Carter W. H.
- 12.↵
- Moghimi N.,
- Kim S.-J.,
- Park S.-I.
- 13.↵
- Kirsch L. E.
- 14.↵
- 15.↵
- Halls N. A.
- 16.↵
- Krebsbach T.,
- Schröder C.,
- Matthies C.
- 17.↵
- Guazzo D. M.
- 18.↵
- Akers M.,
- Larrimore D.,
- Morton Guazzo D.
- 19.↵
- Moghimi N.,
- Park S. I.
- 20.↵
- Pethe V.,
- Dove M.,
- Terentiev A.
- 21.↵
- Gibney M.
- 22.↵Dr. Erwin Post, Merz Group Services GmbH PDA Europe Conference on Pharmaceutical Microbiology, March 15–16, 2011 in Berlin, Germany. .
- 23.↵
- Morrical B. D.,
- Goverde M.,
- Grausse J.,
- Gerwig T.,
- Vorgrimler L.,
- Morgen R.,
- Büttiker J.-P.
- 24.↵
- Brown H.,
- Mahler H.-C.,
- Mellman J.,
- Nieto A.,
- Wagner D.,
- Schaar M.,
- Mathaes R.,
- Kossinna J.,
- Schmitting F.,
- Dreher S.,
- Roehl H.,
- Hemminger M.,
- Wuchner K.
- 25.↵
- Hogreve M.,
- Langlois C.,
- Menier M. C.,
- Aliaskarisohi S.
- 26.↵U.S. Pharmacopeial Convention. General Chapter <1207> Packaging Integrity Evaluation—Sterile Product. In USP–39 NF 34, USP, Rockville, MD, 2019.
- 27.↵
- Keller S.
- 28.↵
- Pethe V.
- 29.↵Pharmaceutical Package Integrity, Technical Report No. 27. PDA J. Pharm. Sci. Technol. 1998, 52 (S2).
- 30.↵International Organization for Standardization. ISO 15747: Plastic Containers for Intravenous Injection. ISO: Geneva, Switzerland, 2003.
- 31.↵International Organization for Standardization. ISO 14644-1: 2015 Cleanrooms and associated controlled Environments—Part 1: Classification of air cleanliness by particle concentration. ISO: Geneva, Switzerland, 2015.
- 32.↵
- 33.↵
- Denyer S. P.,
- Baird R. M.
- Kirsch L. E.
In This Issue
PDA Journal of Pharmaceutical Science and Technology
Vol. 73, Issue 5
September/October 2019
Single-Use System Integrity I: Using a Microbial Ingress Test Method to Determine the Maximum Allowable Leakage Limit (MALL)
Saeedeh Aliaskarisohi, Marc Hogreve, Carole Langlois, Jonathan Cutting, Magali Barbaroux, Jean-Marc Cappia, Marie-Christine Menier
PDA Journal of Pharmaceutical Science and Technology Sep 2019, 73 (5) 459-469; DOI: 10.5731/pdajpst.2018.009688
Single-Use System Integrity I: Using a Microbial Ingress Test Method to Determine the Maximum Allowable Leakage Limit (MALL)
Saeedeh Aliaskarisohi, Marc Hogreve, Carole Langlois, Jonathan Cutting, Magali Barbaroux, Jean-Marc Cappia, Marie-Christine Menier
PDA Journal of Pharmaceutical Science and Technology Sep 2019, 73 (5) 459-469; DOI: 10.5731/pdajpst.2018.009688
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