Eric Kurtz

Eric Kurtz

Sr. Specialist, Technical product Development

October 28, 2022

Crystal Zenith® Pre-Fillable Syringe Systems: Introducing the 2.25mL Insert Needle Barrel Assembly

Daikyo Crystal Zenith® (CZ) Pre-Fillable Syringe (PFS) systems were designed to maintain purity, integrity, and efficacy of premium biopharmaceutical therapies. The system minimizes the potential contamination issues associated with glass and helps to reduce the risk of product interactions, delays in development and scale up, and possible recalls. As an extension of the existing 1mL Long Insert Needle Barrel Assembly, West and Daikyo are proud to introduce the new 2.25mL Insert Needle (IN), providing drug manufacturers a larger volume option for the next generation of autoinjectors for at-home therapies.

Daikyo CZ Prefillable Syringes

The new CZ 2.25mL Insert Needle Barrel Assembly is a sterile pre-fillable component of hypodermic syringes with an inserted cannula, intended for single use. It is available as Ready-to-Use (RU) 2.25mL Barrel Assembly, which consists of the Daikyo Crystal Zenith® barrel, attached 27G ½” Thin Wall (TW) needle molded directly into the barrel, and Rigid Needle Shield. The CZ 2.25mL IN PFS is paired with the Daikyo Ready-to-Use-Validated (RUV) 2.25mL plunger in formulation D21-7HW and associated polypropylene plunger rod

The Benefits of Daikyo CZ Cyclic Olefin Polymer (COP)

Daikyo CZ is a COP that provides benefits beyond traditional glass containment systems, in particular, tight dimensional tolerances and variation, high breakage resistance, low particulate contamination and characterized extractables profile.

For molecules with a fill volume up to 2.25mL, CZ IN in syringe systems are a top choice to protect sensitive molecules. Drugs using CZ IN syringes are approved in multiple markets. CZ IN syringes are a low-risk solution to the challenge of particles and protein aggregation. Their break-resistance also reduces concern of delivery system failure due to a broken primary container. For drug developers wishing to avoid glass, the CZ 2.25mL insert needle syringe system protects sensitive molecules as no silicone oil is used for functionality, as well as being free of tungsten and glue, while reducing the worry of container breakage during high force, larger volume injections.

West-Daikyo Container Closure Components

Combining these benefits with West’s and Daikyo market-leading elastomer technology, including FluroTec® lamination, provides the drug manufacturer with a more flexible system capable of meeting functional and physical performance across key metrics such as container closure integrity, break loose and extrusion forces, and delivered dose accuracy.

For instance, when testing for flange breakage, guided by ISO 11040-6:2019, Prefilled syringes — Part 6: Plastic barrels for injectables and sterilized sub-assembled syringes ready for filling, no samples were observed with broken flanges. Furthermore, when testing for Hub Breakage Force specifically, the CZ 2.25mL Barrel Assembly provided impressive minimum, average, and maximum breakage forces of 36N, 45N, and 49N, respectively.


Flange breakage test plot
Figure 1: Example plot of flange breakage test data, in which all observed failures occurred at the hub. In this case the barrel assembly is supported by the flange, in a needle tip down vertical position, and a loading pin is inserted at a test speed of 100mm/min. Note that the number of samples shown in this plot is limited for conciseness but is otherwise representative of the overall dataset.
ISO 11040-62019 Hub breakage test
Figure 2: Example plot of hub breakage test data, guided by ISO 11040-6:2019. Note that the number of samples shown in this plot is limited for conciseness, but is otherwise representative of the overall dataset.

Additionally, a study conducted at West[1] based on ASTM D6653/D6653M-13, “Standard Test Methods for Determining the Effects of High Altitude on Packaging Systems by Vacuum Method”, found that CZ-based systems exhibited high resistance to plunger movement in low pressure environments, while also resisting plunger migration when pressures returned to standard atmospheric conditions. The lower pressures (vacuum condition) exhibited on the syringe system at higher altitudes can cause a placed plunger to move. When pressure is increased and the plunger returns to its original position, this plausibly creates a pathway for microbial ingress. It should be noted that comparative results must be considered within the relative context of which they are studied, but these results nonetheless provide a baseline of confidence for comparable or better performance in CZ-based systems.

Additionally, break-loose and extrusion forces in CZ syringes were shown to remain relatively consistent during long term storage, exhibiting minimal variability in force as a function of distance.

Advantages of Daikyo CZ

Daikyo CZ is the break-resistant, polymer syringe system of choice to protect larger volume sensitive molecules for self-administration. The demonstrated benefits of COP CZ compared to siliconized glass ultimately can provide improved functional performance while reducing risk throughout the development, manufacturing, and end user process, especially for high value and highly sensitive drugs like biologics.

For further information on the Daikyo Crystal Zenith® 2.25mL Insert Needle Barrel Assembly and related components, please contact your account representative or visit the site below to browse product attributes and additional resources.

Crystal Zenith® and RUV are trademarks of Daikyo Seiko, Ltd. FluroTec® is a registered trademark of West Pharmaceutical Services, Inc. In the United States and other jurisdictions.

Crystal Zenith® component and FluroTec® lamination technologies are licensed from Daikyo Seiko, Ltd.



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