Research ArticleResearch
Impact of Dimensional Variability of Primary Packaging Materials on the Break-Loose and Gliding Forces of Prefilled Syringes
Ramadan Alkeefo, Christian Hotz and Daniel Kolacyak
PDA Journal of Pharmaceutical Science and Technology September 2024, 78 (5) 572-585; DOI: https://doi.org/10.5731/pdajpst.2023.012916
Ramadan Alkeefo
1Department Vetter optimization system, Vetter Pharma-Fertigung GmbH & Co. KG, 88212, Ravensburg, Germany; and
2Faculty of Technology and Management, RWU Ravensburg-Weingarten University of Applied Sciences, 88250, Weingarten, Germany.
Christian Hotz
1Department Vetter optimization system, Vetter Pharma-Fertigung GmbH & Co. KG, 88212, Ravensburg, Germany; and
Daniel Kolacyak
2Faculty of Technology and Management, RWU Ravensburg-Weingarten University of Applied Sciences, 88250, Weingarten, Germany.

References
- 1.↵
- 2.↵
- 3.↵
- Lee S.
- 4.↵U.S. Food and Drug Administration. Guidance for Industry: Container Closure Systems for Packaging Human Drugs and Biologics, 1999. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/container-closure-systems-packaging-human-drugs-and-biologics (accessed August 8, 2023).
- 5.↵
- 6.↵
- Mandal P.,
- Khanam J.,
- Karmakar S.,
- Pal T. K.,
- Barma S.,
- Chakraborty S.,
- Bera R.,
- Poddar S.
- 7.↵CS Analytical. Break Loose and Glide Testing. https://csanalytical.com/breakloose-and-glide/ (accessed August 20, 2023).
- 8.↵
- Cordier S.,
- Guillemot L.-H.,
- Chardonnet A.
- 9.↵
- 10.↵
- Zeiss B.
- 11.↵
- 12.↵
- 13.↵
- Zeiss B.
- 14.↵
- 15.↵
- Fang L.,
- Richard C. A.,
- Shi G. H.,
- Dong X.,
- Rase M.,
- Wang T.
- 16.↵
- 17.↵ZwickRoell GmbH & Co. KG. Testing of Prefilled Syringes to ISO 11040: Syringe Testing for Assessment of the Integrity and Functionality of Prefilled Syringes. https://www.zwickroell.com/industries/medicalpharmaceutical/therapy-systems/syringe-testing-iso-11040/ (accessed May 4, 2024).
- 18.↵International Organization for Standardization. ISO 11040-4: Prefilled Syringes - Part 4: Glass Barrels for Injectables and Sterilized Subassembled Syringes Ready for Filling. ISO: Geneva, 2015.
- 19.↵
- 20.↵U.S. Pharmacopeial Convention. General Chapter <789> Particulate Matter in Ophthalmic Solutions. http://ftp.uspbpep.com/v29240/usp29nf24s0_c789.html (accessed September 12, 2023).
- 21.↵
- Dave V. P.,
- Joseph J.,
- Jayabhasker P.,
- Pappuru R. R.,
- Pathengay A.,
- Das T.
- 22.↵
- Ayalon A.,
- Rubowitz A.,
- Roy P. K.,
- Shoval S.,
- Legchenkova I.,
- Bormashenko E.
- 23.↵
- Melo G. B.,
- Figueira A. C. M.,
- Batista F. A. H.,
- Filho A. A. S. L.,
- Rodrigues E. B.,
- Belfort R.,
- Maia M.
- 24.↵
- 25.↵Carl Zeiss, A. G. ZEISS CONTURA: Prepared for All Challenges - Today and Tomorrow. https://www.zeiss.com/metrology/products/systems/coordinate-measuring-machines/bridge-type-cmms/contura-2019.html (accessed April 11, 2023).
- 26.↵European Medicines Agency. Quality by Design. https://www.ema.europa.eu/en/human-regulatory/research-development/quality-design (accessed October 29, 2023).
In This Issue
PDA Journal of Pharmaceutical Science and Technology
Vol. 78, Issue 5
September/October 2024
Impact of Dimensional Variability of Primary Packaging Materials on the Break-Loose and Gliding Forces of Prefilled Syringes
Ramadan Alkeefo, Christian Hotz, Daniel Kolacyak
PDA Journal of Pharmaceutical Science and Technology Sep 2024, 78 (5) 572-585; DOI: 10.5731/pdajpst.2023.012916
Jump to section
Related Articles
- No related articles found.
Cited By...
- No citing articles found.