Suitability of a container/delivery system for a drug product depends upon the chemical/physical properties of the system’s materials of construction (glass, polymer, elastomer)—such as interaction with drug product, gas permeability and durability through temperature cycles. This section presents papers on these and similar topics.
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This is a brief comparison of the advantages of COP versus glass.
In order to mitigate health care worker’s risk of exposure to hazardous injectable drugs during the transfer from vial to device, it is necessary to consider the right combination of vial stopper and spike. This investigation serves to understand issue of spikes pushing stoppers into the vial. It shows that the push-in force limit varies with the spike size, stopper materials and design. The spike puncture force is impacted by spike design, surface lubricity, stopper materials and design. Stopper push-in force limit and spike puncture force should be coordinated and optimized to prevent the stopper from being pushed into the vial, causing splashes and exposure to the drug.
Discusses proper sealing parameters and the effects of temperature and time on vial/stopper performance and CCI.
The container closure system (CCS) determines container closure integrity (CCI) performance, and CCI quality is essential for drug product integrity throughout the entire sealed drug product life cycle. A typical CCS is composed of three major components: rubber stopper, vial, and aluminum seal. This presentation provides critical considerations for CCS optimization through a combination of test evaluation, modeling, and database management – to enable sufficient seal performance together with visual CCS quality acceptance. It is vital to have compatible CCS component dimensions together with reliable material sealing properties for long-lasting CCI quality performance to satisfy mandatory patient safety. Employing both testing evaluation and modeling on a typical 20 mm CCS, an in-depth case study of critical CCS component compatibility and its impact on CCI quality performance will be demonstrated. This robust optimization methodology is composed of a state-of-the-art combination of disciplines including polymer science, materials technology, non-linear mathematical modeling, advanced data processing, computer simulation, and robust database management. The conclusions provide scientific insight into how to proactively consider, control, and maintain a reliable container closure system (CCS) not only for long-lasting CCI quality performance to satisfy patient safety but also visual CCS quality acceptance throughout the entire sealed drug product life cycle.
Studies were performed to compare these flange strength and dimensional variability of CZ 1mL long syringes versus glass 1mL long syringes.
To develop assays to determine protein sensitivity to tungstate and the effects of pH and ionic strength on protein aggregation by tungstate polyoxyanions.
Compares moisture content in lyocakes stored in vials sealed with stoppers of different rubber formulations.
Discussed is the diffusion of selected organic compounds through cyclic olefin polymer - permeability coefficients are correlated with molecular volume and activation energy of diffusion. <p><em>F. Welle. International Journal of Pharmaceutics, 473, 510-517 (2014) </em></p>
This article examines the performance of microcentrifuge tubes comprising Daikyo Crystal Zenith® cyclic olefin polymer to those comprising polypropylene. Cyclic olefin polymer tubes perform as well, with the added benefit of a lower extractables profile. <p><em>L. Waxman, et al. BioTechniques, 62 (5), 223-228 (May 2017)</em></p>
This article demonstrates that vials comprising Daikyo Crystal Zenith<sup><sup>®</sup></sup> cyclic olefin polymer are well-suited to cryogenic storage/transport of cell therapy products. <p><em>E. Woods, et al. Regen. Med., 5 (4), 659-667 (2010)</em></p>
<em>S.S. Quadry, et al. International Journal of Pharmaceutics, 252 (1-2), 207-212 (2003)</em>
This article discusses some of the fundamental properties of cyclic polyolefins, i.e., polymers and co-polymers comprising norborene (bicyclo[2.2.1]hept-2-ene) and ethylene.
<p>This is a review article on ring-opening olefin metathesis polymerization by R.H. Grubbs (California Institute of Technology), 2005 Nobel Laureate in Chemistry. This type of polymerization is employed in the production of cyclic olefin polymers.</p> <p><em>R.H. Grubbs. Tetrahedron 60, 7117–7140 (2004)</em></p>
This articles discusses the chemistry of polymerization of cyclic olefin polymers by ring-opening metathesis.<br /> <div> </div> <em>J. Cui, et al. Polymers 7 (8), 1389-1409 (2015)</em>
This article briefly compares the benefits of cyclic olefin polymers to glass in container/delivery syustems for parenteral drug products.
The article cited here considers, experimentally and theoretically, the stress relaxation of elastomers under compression versus time, and how said relaxation may affect container closure integrity of elastomer-stoppered vials.<br /> <em>Q. Zeng and X. Zhao. PDA Journal of Pharmaceutical Science and Technology, 72 (2), 134 - 148 (March-April 2018) </em>
Daikyo Crystal Zenith® is a registered trademark of Daikyo Seiko, Ltd.
Daikyo Crystal Zenith® technology is a registered trademark of Daikyo Seiko, Ltd.