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1

Single-Use System Integrity II: Characterization of Liquid Leakage Mechanisms.

Aliaskarisohi S, Kumar C, Hogreve M, Montenay N, Cutting J, Mundrigi A, Paramathma A. Aliaskarisohi S, et al. PDA J Pharm Sci Technol. 2021 May-Jun;75(3):258-272. doi: 10.5731/pdajpst.2020.012088. Epub 2020 Nov 16. PDA J Pharm Sci Technol. 2021. PMID: 33199514

2

Single-Use System Integrity I: Using a Microbial Ingress Test Method to Determine the Maximum Allowable Leakage Limit (MALL).

Aliaskarisohi S, Hogreve M, Langlois C, Cutting J, Barbaroux M, Cappia JM, Menier MC. Aliaskarisohi S, et al. PDA J Pharm Sci Technol. 2019 Sep-Oct;73(5):459-469. doi: 10.5731/pdajpst.2018.009688. Epub 2019 Apr 19. PDA J Pharm Sci Technol. 2019. PMID: 31004038

3

Single-Use System Integrity III: Gas Flow Rate Through Laser-Drilled Microchannels in Polymeric Film Material.

Aliaskarisohi S, Urbaniak T, Hogreve M. Aliaskarisohi S, et al. PDA J Pharm Sci Technol. 2021 Jun 15:pdajpst.2021.012631. doi: 10.5731/pdajpst.2021.012631. Online ahead of print. PDA J Pharm Sci Technol. 2021. PMID: 34131014

4

Method Development for Container Closure Integrity Evaluation via Headspace Gas Ingress by Using Frequency Modulation Spectroscopy.

Victor KG, Levac L, Timmins M, Veale J. Victor KG, et al. PDA J Pharm Sci Technol. 2017 Nov-Dec;71(6):429-453. doi: 10.5731/pdajpst.2017.007518. Epub 2017 Jul 20. PDA J Pharm Sci Technol. 2017. PMID: 28733333

5

High-voltage leak detection of a parenteral proteinaceous solution product packaged in form-fill-seal plastic laminate bags. Part 1. Method development and validation.

Damgaard R, Rasmussen M, Buus P, Mulhall B, Guazzo DM. Damgaard R, et al. PDA J Pharm Sci Technol. 2013 Nov-Dec;67(6):634-51. doi: 10.5731/pdajpst.2013.00945. PDA J Pharm Sci Technol. 2013. PMID: 24265304

6

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.

Rasmussen M, Damgaard R, Buus P, Mulhall B, Guazzo DM. Rasmussen M, et al. PDA J Pharm Sci Technol. 2013 Nov-Dec;67(6):652-63. doi: 10.5731/pdajpst.2013.00946. PDA J Pharm Sci Technol. 2013. PMID: 24265305

7

Non-destructive vacuum decay method for pre-filled syringe closure integrity testing compared with dye ingress testing and high-voltage leak detection.

Simonetti A, Amari F. Simonetti A, et al. PDA J Pharm Sci Technol. 2015 Jan-Feb;69(1):108-22. doi: 10.5731/pdajpst.2015.01004. PDA J Pharm Sci Technol. 2015. PMID: 25691719

8

Artificial Leaks in Container Closure Integrity Testing: Nonlinear Finite Element Simulation of Aperture Size Originated by a Copper Wire Sandwiched between the Stopper and the Glass Vial.

Nieto A, Roehl H, Brown H, Adler M, Chalus P, Mahler HC. Nieto A, et al. PDA J Pharm Sci Technol. 2016 Jul-Aug;70(4):313-24. doi: 10.5731/pdajpst.2015.006080. Epub 2016 Mar 28. PDA J Pharm Sci Technol. 2016. PMID: 27020649

9

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.

Rasmussen M, Damgaard R, Buus P, Guazzo DM. Rasmussen M, et al. PDA J Pharm Sci Technol. 2013 Nov-Dec;67(6):664-9. doi: 10.5731/pdajpst.2013.00947. PDA J Pharm Sci Technol. 2013. PMID: 24265306

10

Pharmaceutical container/closure integrity. VI: A report on the utility of liquid tracer methods for evaluating the microbial barrier properties of pharmaceutical packaging.

Kirsch LE. Kirsch LE. PDA J Pharm Sci Technol. 2000 Jul-Aug;54(4):305-14. PDA J Pharm Sci Technol. 2000. PMID: 10969527

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