Research ArticlePDA Paper
Points to Consider: Best Practices to Identify Particle Entry Routes along the Manufacturing Process for Parenteral Formulations
Sylvia Anger, Cecile Begat, Vincent Crnko, GianMaurizio Fantozzi, Wadi Farach, Sean Fitzpatrick, Brian Gallagher, Stefan Huelsmann, Paul Kinsey, Vincent Langlade, Ghislain Lefevre, Elise Legendre, Kevin McLean, Jahanvi Miller, Ravi Patel, Anthony Perry, Herve Soukiassian, Amy Stanton, Dorothee Streich, Christopher Timmons, DAVID Vaneylen, Tony van Hoose, Linda Wildling and Mike Windover
PDA Journal of Pharmaceutical Science and Technology November 2019, 73 (6) 635-647; DOI: https://doi.org/10.5731/pdajpst.2019.010645
Sylvia Anger
1Bayer, Berlin Germany;
Cecile Begat
2Bayer AG, Basel, Switzerland;
Vincent Crnko
3Becton, Dickinson and Company, Grenoble France;
GianMaurizio Fantozzi
4Stevenato Group, Via Molinella, Padua, Italy;
Wadi Farach
5Amgen Inc., Thousand Oaks, CA, USA;
Sean Fitzpatrick
6Gerresheimer, Vineland, NJ, USA;
Brian Gallagher
7Aptar Pharma, Congers, NY, USA;
Stefan Huelsmann
8Bayer AG, Kaiser-Wilhelm-Allee, Leverkusen, Germany;
Paul Kinsey
9GlaxoSmithKline, Durham, United Kingdom;
Vincent Langlade
10SGD Pharma Packaging Group Inc., Puteaux, Haut de Seine, France;
Ghislain Lefevre
11Becton, Dickinson and Company, Grenoble France;
Elise Legendre
12SANOFI, Paris, France;
Kevin McLean
13SGD Pharma Packaging Group Inc., Puteaux, Haut de Seine, France;
Jahanvi Miller
14Parenteral Drug Association, Bethesda, MD, USA;
Ravi Patel
15West Pharmaceutical Services, Exton, PA, USA;
Anthony Perry
16Schott North America, Inc., Lebanon, PA, USA;
Herve Soukiassian
17Becton Dickinson, Le Pont-de-Claix, France;
Amy Stanton
18Amgen Inc., Thousand Oaks, CA, USA;
Dorothee Streich
19Bayer AG, Kaiser-Wilhelm-Allee, Leverkusen, Germany;
Christopher Timmons
20Corning, Painted Post, NY, USA;
DAVID Vaneylen
21Datwyler Pharma Packaging, Alken, Belgium;
Tony van Hoose
22Global Aseptic Process Solutions, LLC, Bangor, PA, USA;
Linda Wildling
23Takeda, Singen, Germany; and
Mike Windover
24Gerresheimer, Vineland, NJ, USA

References
- 1.↵U.S. Pharmacopeial Convention. General Chapter <1> Injections and Implanted Drug Products (Parenterals)–Product Quality Tests. In USP 41–NF 36; USP: Rockville, MD, 2018; pp 5915–5920.
- 2.↵Parenteral Drug Association. Technical Report No. 78: Particulate Matter in Oral Dosage Forms; Bethesda, MD, 2017.
- 3.↵Parenteral Drug Association. Technical Report No. 44: Quality Risk Management for Aseptic Processes; Bethesda, MD, 2008.
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- Ayres J.,
- Chavez A.,
- Devera M.,
- Miller J.,
- Ross D.,
- Shabushnig J.,
- Vargo S.,
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- Watson R.
In This Issue
PDA Journal of Pharmaceutical Science and Technology
Vol. 73, Issue 6
November/December 2019
Points to Consider: Best Practices to Identify Particle Entry Routes along the Manufacturing Process for Parenteral Formulations
Sylvia Anger, Cecile Begat, Vincent Crnko, GianMaurizio Fantozzi, Wadi Farach, Sean Fitzpatrick, Brian Gallagher, Stefan Huelsmann, Paul Kinsey, Vincent Langlade, Ghislain Lefevre, Elise Legendre, Kevin McLean, Jahanvi Miller, Ravi Patel, Anthony Perry, Herve Soukiassian, Amy Stanton, Dorothee Streich, Christopher Timmons, DAVID Vaneylen, Tony van Hoose, Linda Wildling, Mike Windover
PDA Journal of Pharmaceutical Science and Technology Nov 2019, 73 (6) 635-647; DOI: 10.5731/pdajpst.2019.010645
Points to Consider: Best Practices to Identify Particle Entry Routes along the Manufacturing Process for Parenteral Formulations
Sylvia Anger, Cecile Begat, Vincent Crnko, GianMaurizio Fantozzi, Wadi Farach, Sean Fitzpatrick, Brian Gallagher, Stefan Huelsmann, Paul Kinsey, Vincent Langlade, Ghislain Lefevre, Elise Legendre, Kevin McLean, Jahanvi Miller, Ravi Patel, Anthony Perry, Herve Soukiassian, Amy Stanton, Dorothee Streich, Christopher Timmons, DAVID Vaneylen, Tony van Hoose, Linda Wildling, Mike Windover
PDA Journal of Pharmaceutical Science and Technology Nov 2019, 73 (6) 635-647; DOI: 10.5731/pdajpst.2019.010645
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