Research ArticleTechnology/Application
High-Voltage Leak Detection of a Parenteral Proteinaceous Solution Product Packaged in Form-Fill-Seal Plastic Laminate Bags. Part 2. Method Performance as a Function of Heat Seal Defects, Product–Package Refrigeration, and Package Plastic Laminate Lot
Mats Rasmussen, Rasmus Damgaard, Peter Buus, Brian Mulhall and Dana Morton Guazzo
PDA Journal of Pharmaceutical Science and Technology November 2013, 67 (6) 652-663; DOI: https://doi.org/10.5731/pdajpst.2013.00946
Mats Rasmussen
1Novo Nordisk A/S, Bagsværd, Denmark;
Rasmus Damgaard
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
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 2. Method Performance as a Function of Heat Seal Defects, Product–Package Refrigeration, and Package Plastic Laminate Lot
Mats Rasmussen, Rasmus Damgaard, Peter Buus, Brian Mulhall, Dana Morton Guazzo
PDA Journal of Pharmaceutical Science and Technology Nov 2013, 67 (6) 652-663; DOI: 10.5731/pdajpst.2013.00946
High-Voltage Leak Detection of a Parenteral Proteinaceous Solution Product Packaged in Form-Fill-Seal Plastic Laminate Bags. Part 2. Method Performance as a Function of Heat Seal Defects, Product–Package Refrigeration, and Package Plastic Laminate Lot
Mats Rasmussen, Rasmus Damgaard, Peter Buus, Brian Mulhall, Dana Morton Guazzo
PDA Journal of Pharmaceutical Science and Technology Nov 2013, 67 (6) 652-663; DOI: 10.5731/pdajpst.2013.00946
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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.