High-Voltage Leak Detection of a Parenteral Proteinaceous Solution Product Packaged in Form-Fill-Seal Plastic Laminate Bags. Part 3. Chemical Stability and Visual Appearance of a Protein-Based Aqueous Solution for Injection as a Function of HVLD Exposure

Mats Rasmussen; Rasmus Damgaard; Peter Buus; Dana Morton Guazzo

doi:10.5731/pdajpst.2013.00947

Research ArticleTechnology/Application

High-Voltage Leak Detection of a Parenteral Proteinaceous Solution Product Packaged in Form-Fill-Seal Plastic Laminate Bags. Part 3. Chemical Stability and Visual Appearance of a Protein-Based Aqueous Solution for Injection as a Function of HVLD Exposure

Mats Rasmussen, Rasmus Damgaard, Peter Buus and Dana Morton Guazzo

PDA Journal of Pharmaceutical Science and Technology November 2013, 67 (6) 664-669; DOI: https://doi.org/10.5731/pdajpst.2013.00947

Mats Rasmussen

1Novo Nordisk A/S, Bagsværd, Denmark; and

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Rasmus Damgaard

1Novo Nordisk A/S, Bagsværd, Denmark; and

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Peter Buus

1Novo Nordisk A/S, Bagsværd, Denmark; and

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Dana Morton Guazzo

2RxPax, LLC, Bridgewater, NJ, USA

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For correspondence: dguazzo@rxpax.com

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Reference

1.↵
1. Bigwarfe P. Jr.,
2. Domin-Turza A.,
3. Hwang E.,
4. Leidner S.,
5. McGinley C.,
6. Olson K.,
7. Nachtigall M.
Elucidation of an Unusual Mechanism of Drug Product Degradation Caused by a Leak Detection Instrument. Presented at the Annual Meeting of the American Association of Pharmaceutical Scientists, Atlanta, GA, Nov. 20, 2008.

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PDA Journal of Pharmaceutical Science and Technology

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High-Voltage Leak Detection of a Parenteral Proteinaceous Solution Product Packaged in Form-Fill-Seal Plastic Laminate Bags. Part 3. Chemical Stability and Visual Appearance of a Protein-Based Aqueous Solution for Injection as a Function of HVLD Exposure

Mats Rasmussen, Rasmus Damgaard, Peter Buus, Dana Morton Guazzo

PDA Journal of Pharmaceutical Science and Technology Nov 2013, 67 (6) 664-669; DOI: 10.5731/pdajpst.2013.00947

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Mats Rasmussen, Rasmus Damgaard, Peter Buus, Dana Morton Guazzo

PDA Journal of Pharmaceutical Science and Technology Nov 2013, 67 (6) 664-669; DOI: 10.5731/pdajpst.2013.00947

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Cited By...

Feasibility of Using Fluorescence Spectrophotometry to Develop a Sensitive Dye Immersion Method for Container Closure Integrity Testing of Prefilled Syringes

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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.

[1] 1.↵
Bigwarfe P. Jr.,
Domin-Turza A.,
Hwang E.,
Leidner S.,
McGinley C.,
Olson K.,
Nachtigall M.
Elucidation of an Unusual Mechanism of Drug Product Degradation Caused by a Leak Detection Instrument. Presented at the Annual Meeting of the American Association of Pharmaceutical Scientists, Atlanta, GA, Nov. 20, 2008.

[2] Bigwarfe P. Jr.,

[3] Domin-Turza A.,

[4] Hwang E.,

[5] Leidner S.,

[6] McGinley C.,

[7] Olson K.,

[8] Nachtigall M.

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High-Voltage Leak Detection of a Parenteral Proteinaceous Solution Product Packaged in Form-Fill-Seal Plastic Laminate Bags. Part 3. Chemical Stability and Visual Appearance of a Protein-Based Aqueous Solution for Injection as a Function of HVLD Exposure

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Parenteral Drug Association, Inc.