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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.
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.
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.
References:
[1] Waxman, Lloyd; Murray, Harold; Vilivalam, Vinod. EVALUATION OF PISTON MOVEMENT AND CONTAINER INTEGRITY UNDER SEVER STORAGE CONDITIONS IN PLASTIC AND GLASS PREFILLED SYRINGES. 2012
Particles in parenteral drug products continue to be an important concern. At the April-2017 AAPS Workshop <strong>Challenges and Patient Impact of Particles in Biologics</strong>, Fran DeGrazio, VP of Scientific Affairs and Technical Services, spoke on the topic: <em>Unique Considerations for Testing and Understanding Particle Loads for Primary Packaging Components.</em> <br />
West’s customers are very familiar with our Drug Master Files (DMFs) and Letters of Authorization. West maintains some of the most active DMFs held by the FDA and Health Canada, and we’ve provided customers with over 9,000 LOAs since 2008.
At West, we are by the side of our team members - supporting your training and development needs, providing opportunities to advance in your career and reach your full potential, while maintaining your well-being and work-life balance. In our Team Member Spotlight, learn more about what it is like to work at West and hear about the experiences and careers of some of our team members around the world.
In Part I of this two-part series, several of the challenges with USP<789> <em>Particulate Matter in Ophthalmic Solutions</em> were discussed. Namely, the limits were established before routine intravitreal injections existed and the same acceptance criteria are applied to two different particle detection methods with different capabilities. Other challenges include the mismatch between required analysis volume and the very small fill volumes of ophthalmic injections and the lack of translatable limits for the syringe system alone. Regardless of the potential gaps in the pharmacopeial chapter, it is nevertheless clear that for ophthalmic injections, the industry expectations are to strive for the lowest possible visible and subvisible particle levels that are achievable.
As cell therapies are making their way to the market, safe and efficient transfer/delivery presents a challenge. Needles and syringes are commonly used to retrieve cell therapies from vials, posing the risk of needle stick injury. To address this, West has evaluated the suitability of its needle-free polycarbonate vial adapters (VAs) for withdrawing contents from vials from both a compatibility and performance standpoint.
Amy Kim
Sr. Specialist, Scientific Communications, SA & TS