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West and its partner Daikyo have introduced a superior quality elastomeric piston the Daikyo D Sigma® 1mL long piston, substantially raising the standard for product acceptance. The D Sigma piston combines Daikyo best practices with a known formulation (D21-7H), Daikyo Flurotec® film, RB2 Coating, RSV® and RUV® processing with key innovation improvements of automated dimensional measurements, tight Acceptable Quality Levels (AQLs), particulate testing per ISO 8871-3, and enhanced vision inspection to achieve high levels of performance and consistency.
Automated measurements of critical to function dimensions and the application of tight AQLs for defects allows for lower variability, maximizing part-to-part consistency and reducing risk. The new Daikyo D Sigma 1mL long piston has been tested for performance with industry standard ISO glass syringes for container closure integrity (CCI) and breakloose and gliding forces to show this impact. These evaluations show that the piston can maintain CCI via pressure testing, stationary testing and vacuum decay testing in line with the USP <1207> guidance. Evaluation for breakloose and gliding forces also show performance suitable for use with industry standard ISO glass syringes for manual and auto-injector applications. Additional data for performance evaluations will be collected over time.
The D21-7H formulation is also supported with Theoretical Material Extractables and Material Characteristic testing. Daikyo’s industry experience and innovation excellence has produced pistons that are designed to exceed expectations by combining the best of Daikyo materials, properties and inspection.
Learn more about the D Sigma component offering here or contact your Account Manager or Technical Account Specialist.
D Sigma®, Daikyo Flurotec®, RSV® and RUV® are registered trademarks of Daikyo Seiko, Ltd.
随着医药科技不断发展和进步，中国的药品审评标准在不断改变和提高，过去的药品审评标准没有强制要求仿制药与原研药质量和疗效一致，所以有些药品在质量、疗效上与原研药存在一定差距，需要改进提高。自2015年开始，国家药品监督管理局（原国家食品药品监督管理总局）推出仿制药质量和疗效一致性评价，借以提高我国仿制药的质量和疗效。质量和疗效视为等同于原研产品的仿制药将在公立医院的招标和处方中享受优先待遇。
Our team in Waterford, Ireland recently welcomed its newest “team member.” In partnership with BUMBLEance, the team is excited to launch the new children’s regional ambulance service, BUMBLEance #15, which will operate and service children from the Southeast Region of Ireland. The new vehicle will be permanently based in Waterford’s car park.
Drug delivery via cartridge-based systems has been around for many years, with traditional applications being for the dental and insulin markets. These traditional markets will continue to maintain much of the volume for cartridge-based systems in the future; however, there is an increasing trend toward other therapeutic classes of drugs, such as those that treat auto-immune diseases, that never used cartridges before. This trend, along with the projected growth in the insulin market, indicates substantial overall growth in the cartridge space over the next several years. This Blog discusses the issues driving these trends and the West product portfolio in the cartridge market.
Effective change control systems are important for pharmaceutical packaging materials – especially those in direct contact with drugs. This topic has high visibility in the China pharmaceutical packaging industry as a new change control strategy for pharmaceutical packaging materials is coming.
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