Research ArticleTechnology/Application
Mechanical Container Closure Integrity Test: A Method for Cartridge Systems
Michael W. Foubert, Benoit Lux, Julie Bourguard, Lucas Schultz, Meng John Zhao, Jason D. Marlin, Matthew S. Huser, Henri Hebting and Lei Li
PDA Journal of Pharmaceutical Science and Technology May 2025, 79 (3) 303-319; DOI: https://doi.org/10.5731/pdajpst.2024.012941
Michael W. Foubert
1Eli Lilly and Company, 1223 W Morris Street, Indianapolis, IN 46221;
Benoit Lux
2Eli Lilly and Company, 2 rue du Colonel Lilly, BP 70419 Fegersheim, 67412 Illkirch Cedex, France; and
Julie Bourguard
2Eli Lilly and Company, 2 rue du Colonel Lilly, BP 70419 Fegersheim, 67412 Illkirch Cedex, France; and
Lucas Schultz
2Eli Lilly and Company, 2 rue du Colonel Lilly, BP 70419 Fegersheim, 67412 Illkirch Cedex, France; and
Meng John Zhao
1Eli Lilly and Company, 1223 W Morris Street, Indianapolis, IN 46221;
Jason D. Marlin
3Eli Lilly and Company, 1555 S Harding Street, Indianapolis, IN 46221.
Matthew S. Huser
1Eli Lilly and Company, 1223 W Morris Street, Indianapolis, IN 46221;
Henri Hebting
2Eli Lilly and Company, 2 rue du Colonel Lilly, BP 70419 Fegersheim, 67412 Illkirch Cedex, France; and
Lei Li
1Eli Lilly and Company, 1223 W Morris Street, Indianapolis, IN 46221;

References
- 1.↵U.S. Pharmacopeial Convention, General Chapter <1207> Package Integrity Evaluation—Sterile Products. In USP 39—NF34 Supplement 1, USP: Rockville, MD, 2016.
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- 6.↵U.S. Pharmacopeial Convention, General Chapter <660> Containers—Glass. In USP 46—NF41, USP: Rockville, MD, 2023.
- 7.↵ASTM International, ASTM FF2095-07 Standard Test Methods for Pressure Decay Leak Test for Flexible Packages With and Without Restraining Plates, ASTM: West Conshohocken, PA, 2013.
- 8.↵ASTM International, ASTM D6147-97 Standard Test Method for Vulcanized Rubber and Thermoplastic Elastomer—Determination of Force Decay (Stress Relaxation) in Compression, ASTM: West Conshohocken, PA, 2014.
- 9.↵International Organization for Standardization, ISO 3384-1:2019 Rubber, Vulcanized or Thermoplastic—Determination of Stress Relaxation in Compression—Part 1: Testing at Constant Temperature, ISO: Geneva, 2019.
- 10.↵International Organization for Standardization, ISO 11608-3:2012 Needle-Based Injection Systems for Medical Use—Requirements and Test Methods—Part 3: Finished Containers, ISO: Geneva, 2012.
In This Issue
PDA Journal of Pharmaceutical Science and Technology
Vol. 79, Issue 3
May/June 2025
Mechanical Container Closure Integrity Test: A Method for Cartridge Systems
Michael W. Foubert, Benoit Lux, Julie Bourguard, Lucas Schultz, Meng John Zhao, Jason D. Marlin, Matthew S. Huser, Henri Hebting, Lei Li
PDA Journal of Pharmaceutical Science and Technology May 2025, 79 (3) 303-319; DOI: 10.5731/pdajpst.2024.012941
Mechanical Container Closure Integrity Test: A Method for Cartridge Systems
Michael W. Foubert, Benoit Lux, Julie Bourguard, Lucas Schultz, Meng John Zhao, Jason D. Marlin, Matthew S. Huser, Henri Hebting, Lei Li
PDA Journal of Pharmaceutical Science and Technology May 2025, 79 (3) 303-319; DOI: 10.5731/pdajpst.2024.012941
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