Research ArticleTechnology/Application
High-Voltage Leak Detection of a Parenteral Proteinaceous Solution Product Packaged in Form-Fill-Seal Plastic Laminate Bags. Part 1. Method Development and Validation
Rasmus Damgaard, Mats Rasmussen, Peter Buus, Brian Mulhall and Dana Morton Guazzo
PDA Journal of Pharmaceutical Science and Technology November 2013, 67 (6) 634-651; DOI: https://doi.org/10.5731/pdajpst.2013.00945
Rasmus Damgaard
1Novo Nordisk A/S, Bagsværd, Denmark;
Mats Rasmussen
1Novo Nordisk A/S, Bagsværd, Denmark;
Peter Buus
1Novo Nordisk A/S, Bagsværd, Denmark;
Brian Mulhall
2Whitehouse Laboratories, LLC, Whitehouse, NJ, USA; and
Dana Morton Guazzo
3RxPax, LLC, Bridgewater, NJ, USA

References
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Department of Health and Human Services. Container Closure Systems for Packaging Human Drugs and Biologics, CMC Documentation, Guidance for Industry. U.S. Food and Drug Administration, Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER): Rockville, MD, 1999.
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Department of Health and Human Services. Container and Closure System Integrity Testing in Lieu of Sterility Testing as a Component of the Stability Protocol for Sterile Products. Guidance for Industry. U.S. Food and Drug Administration, Center for Biologics Evaluation and Research (CBER), Center for Drug Evaluation and Research (CDER), Center for Devices and Radiological Health (CDRH), Center for Veterinary Medicine (CVM): Rockville, MD, 2008.
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Department of Health and Human Services. Sterile Drug Products Produced by Aseptic Processing—Current Good Manufacturing Practice. Guidance for Industry. U.S. Food and Drug Administration, Center for Drug Evaluation and Research (CDER), Center for Biologics Evaluation and Research (CBER), Office of Regulatory Affairs (ORA): Rockville, MD, 2004.
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EudraLex. The Rules Governing Medicinal Products in the European Union, Volume 4. EU Guidelines to Good Manufacturing Practice, Medicinal Products for Human and Veterinary Use, Annex 1 Manufacture of Sterile Medicinal Products. Brussels, Belgium: European Union, European Commission, DG Enterprise and Industry - Pharmaceuticals Unit, November 25, 2008 (rev.).
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ASTM F2338–09 (2013) Standard Test Method for Nondestructive Detection of Leaks in Packages by Vacuum Decay Method. ASTM International: West Conshohocken, PA.
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- Möll F.,
- Doyle D.,
- Haerer M.,
- Guazzo D.
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Lenox Laser, 12530 Manor Road, Glen Arm, MD 21057 (www.lenoxlaser.com).
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In This Issue
PDA Journal of Pharmaceutical Science and Technology
Vol. 67, Issue 6
November/December 2013
High-Voltage Leak Detection of a Parenteral Proteinaceous Solution Product Packaged in Form-Fill-Seal Plastic Laminate Bags. Part 1. Method Development and Validation
Rasmus Damgaard, Mats Rasmussen, Peter Buus, Brian Mulhall, Dana Morton Guazzo
PDA Journal of Pharmaceutical Science and Technology Nov 2013, 67 (6) 634-651; DOI: 10.5731/pdajpst.2013.00945
High-Voltage Leak Detection of a Parenteral Proteinaceous Solution Product Packaged in Form-Fill-Seal Plastic Laminate Bags. Part 1. Method Development and Validation
Rasmus Damgaard, Mats Rasmussen, Peter Buus, Brian Mulhall, Dana Morton Guazzo
PDA Journal of Pharmaceutical Science and Technology Nov 2013, 67 (6) 634-651; DOI: 10.5731/pdajpst.2013.00945
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Keywords
- Container-closure
- container-closure integrity
- Defects
- Electrical conductivity and capacitance leak detection
- Form-fill-seal packages
- High-voltage leak detection
- HVLD
- Leak
- Leakage
- Leak detection
- Leak test method
- Package
- Package defects
- Package integrity
- Package integrity method
- Plastic laminate bag
- Protein product
- stability
- Insulin.