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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;
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Rasmus Damgaard
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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Abstract

Part 1 of this three-part research series detailed the development and validation of a high-voltage leak detection test (HVLD, also known as an electrical conductivity and capacitance test) for verifying the container–closure integrity of a small-volume laminate plastic bag containing an aqueous solution formulation of the rapid-acting insulin analogue, insulin aspart (NovoRapid®/NovoLog®) by Novo Nordisk A/S, Bagsværd, Denmark. Leak detection capability was verified using positive controls each with a single laser-drilled hole in the bag film face. In this Part 2, HVLD leak detection capability was further explored in four separate studies. Study 1 investigated the ability of HVLD to detect weaknesses and/or gaps in the bag heat seal. Study 2 checked the HVLD detection of bag holes in packages stored 4 days at ambient conditions followed by 17 days at refrigeration. Study 3 examined HVLD test results for packages tested when cold. Study 4 compared HVLD test results as a function of bag plastic film lots. The final Part 3 of this series will report the impact of HVLD exposure on product visual appearance and chemical stability.

LAY ABSTRACT: In Part 1 of this three-part series, a leak test method based on electrical conductivity and capacitance, also called high-voltage leak detection (HVLD), was used to find leaks in small plastic bags filled with a solution for injection of the rapid-acting insulin analogue, insulin aspart (NovoRapid®/NovoLog®) by Novo Nordisk A/S, Bagsværd, Denmark. In this Part 2, HVLD leak detection capability was further explored in four separate studies. Study 1 investigated the ability of HVLD to detect bag heat seal leaks. Study 2 checked HVLD's ability to detect bag holes after a total of 21 days at ambient plus refrigerated temperatures. Study 3 looked to see if HVLD results changed for packages tested when still cold. Study 4 compared HVLD results for multiple bag plastic film lots. The final Part 3 of this series will report any evidence of drug component degradation caused by HVLD exposure.

  • 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.
  • © PDA, Inc. 2013
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PDA Journal of Pharmaceutical Science and Technology: 67 (6)
PDA Journal of Pharmaceutical Science and Technology
Vol. 67, Issue 6
November/December 2013
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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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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.

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