Research ArticleTechnology/Application
Ozone Generation during High-Voltage Leak Detection: Fiction or Reality?
Sophie Becker, Kai Reimers, Volker Bickert and Martin Becker
PDA Journal of Pharmaceutical Science and Technology July 2018, 72 (4) 404-410; DOI: https://doi.org/10.5731/pdajpst.2016.007153
Sophie Becker
Siegfried-Hameln GmbH, Langes Feld 13, D-51789 Hameln, Germany
Kai Reimers
Siegfried-Hameln GmbH, Langes Feld 13, D-51789 Hameln, Germany
Volker Bickert
Siegfried-Hameln GmbH, Langes Feld 13, D-51789 Hameln, Germany
Martin Becker
Siegfried-Hameln GmbH, Langes Feld 13, D-51789 Hameln, Germany

Reference
- 1.↵EU GMP-Guide Annex 1, §117.
- 2.↵United States Pharmacopeia; United States Pharmacopeial Convention 41-NF 36: Rockville, MD, [2018]. Chapter <1207>. Package integrity evaluation – Sterile products.
- 3.↵
- McGinley C. M.,
- Bigwarfe P.,
- Thiel A.,
- Olson K.,
- Loe Ø.,
- Loffredo D.,
- Joseph J.
- 4.↵DIN 38403-3:2011 Deutsche Einheitsverfahren zur Wasser-, Abwasser- und Schlammuntersuchung- Gasförmige Bestandteile (Gruppe G) – Teil 3: Bestimmung von Ozon. 2: Photometrische Bestimmung mittels N, N-Diethyl-p-phenylendiamin (DPD).
- 5.↵
- Hoigné J.,
- Bader H.
- 6.↵Guidance for Industry Q3B (R2). Impurities in New Drug Products. FDA 2006; ICH Revision 2, Attachment 1.
- 7.↵
- Devins J. C.
In This Issue
PDA Journal of Pharmaceutical Science and Technology
Vol. 72, Issue 4
July/August 2018
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