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

doi:10.5731/pdajpst.2013.00945

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;

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Mats Rasmussen

1Novo Nordisk A/S, Bagsværd, Denmark;

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Peter Buus

1Novo Nordisk A/S, Bagsværd, Denmark;

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Brian Mulhall

2Whitehouse Laboratories, LLC, Whitehouse, NJ, USA; and

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Dana Morton Guazzo

3RxPax, LLC, Bridgewater, NJ, USA

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For correspondence: dguazzo@rxpax.com

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vol. 67 no. 6 634-651

DOI

https://doi.org/10.5731/pdajpst.2013.00945

PubMed

24265304

Published By

Parenteral Drug Association (PDA)

Print ISSN

1079-7440

Online ISSN

1948-2124

History

Published online November 21, 2013.

Author Information

Rasmus Damgaard1,
Mats Rasmussen1,
Peter Buus1,
Brian Mulhall2 and
Dana Morton Guazzo3,*

¹Novo Nordisk A/S, Bagsværd, Denmark;
²Whitehouse Laboratories, LLC, Whitehouse, NJ, USA; and
³RxPax, LLC, Bridgewater, NJ, USA

↵*Corresponding Author: RxPax, LLC 920 Ardsley Lane Bridgewater, NJ 08807. Phone: 908.507.3905, Email: dguazzo{at}rxpax.com

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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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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.

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High-Voltage Leak Detection of a Parenteral Proteinaceous Solution Product Packaged in Form-Fill-Seal Plastic Laminate Bags. Part 1. Method Development and Validation

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