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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
QbD, CQA, QTPP,FEA – what does it all mean? Quality by Design (QbD) can be confusing, but it really doesn’t have to be. QbD was designed to promote an understanding of the product and manufacturing process starting with product development. When designing and developing a product using QbD principles, manufacturers must define desired product performance and identify Critical Quality Attributes (CQAs). The product and process is then designed to meet those product attributes, which leads to understanding the impact of material attributes and process parameters on the CQAs and identification and control of sources of variability. As a result of this knowledge, a company can continually monitor and update its manufacturing process to assure consistent product quality.
To improve the consistent evaluation of the quality and efficacy of generic drugs for injections, National Medical Products Administration of China(NMPA)published the draft guidance “<em>Technical Requirement for Quality and Efficacy Consistency Evaluation on Chemical Generic Injections (Exposure Draft)</em>” (15 October 2019). This indicates that the evaluation of the consistency of injections has finally begun. This Exposure Draft clarifies the specific technical requirements on reference-listed drugs, prescription technology, quality control of bulk drugs and excipient packaging, quality studies and control, stability studies, etc.
The FDA has approved over twenty (20) cell and gene therapy drugs, and with the rapid growth of the cell and gene therapy market, there is greater demand than ever to demonstrate container-closure integrity (CCI) at ultra-low temperatures. To preserve the product’s efficacy, most cell and gene therapy drugs are stored at temperatures below -60ºC. Many of these products are packaged in either vial systems or cryogenic freezing bags. While each of these container-closure systems poses a unique challenge for the evaluation of CCI at ultra-low temperatures, the discussion in this blog focuses specifically on vial systems.
In the final installment of our blog series on corporate responsibility, we are focusing on quality. This topic is at the forefront of all we do at West. After all, we are ultimately in business to serve the patients who use our products – and those patients are counting on us to deliver those products with the highest level of quality possible. We will not compromise on our commitment to quality. <br />
At West, our goal is to partner with customers to mitigate risks of drug/packaging incompatibility, container/device and functional challenges. Although we consider critical quality attributes during development of drug packaging and delivery systems, there can be knowledge gaps of various interfaces based on the specific application of use, such as component-to-container, container-to-device, and container-to-drug.
Cathy Zhao
Director, Scientific Insights Lab, Scientific Affairs & Technical Service