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Innovation in manufacturing involves a spectrum of evolution improvements resulting in what West’s partner Daikyo Seiko, Ltd. considers "Absolute Quality." Recent continuous improvement efforts helped Daikyo achieve even higher levels in cleanliness of elastomer products.
Increasing demands on quality, stringent regulations, trends towards home care treatments by using innovative device technology, and the development of specialized, high value treatments present challenges to companies looking for unique solutions.
The new Daikyo D Sigma® 1mL long piston for prefilled syringe (PFS) leads with innovation excellence. This was developed to address the ever-increasing demands and challenges of the pharmaceutical industry driven towards almost completely particle free components and meeting customer needs for consistency by assuring dimensional stability.
The piston dimensions are critical to the function of the entire packaging system and help provide an increased level of confidence in the PFS system performance. Applying 100% automated control on the piston dimensions allows for lower variability by minimizing part-to-part changeability with consistent and predictable product performance. Further it results in reliable machinability in fill-finish operations while maintaining proper container closure integrity.
Particles and dimensional defects in primary packaging can have significant impact on end-of-line rejects, reducing yield and results higher patient safety. This next generation piston combines several critical quality attributes regarding tight particulate specification for visible and subvisible particulate specification and outstanding vision inspection allowing particle control on every single piston at 0.01mm².
For more information on D Sigma components, visit our website or contact us.
Daikyo D Sigma® and Daikyo D Sigma Innovation Excellence are registered trademarks of Daikyo Seiko, Ltd.
End-of-line rejections or sterility failures can affect drug availability and patient safety. As drugs evolve, demands on packaging systems increase. To meet the increasing quality needs of customers, West has introduced a line of superior quality elastomeric stoppers: Daikyo D Sigma components.<br />
West and its partner Daikyo have introduced a superior quality elastomeric piston the Daikyo D Sigma<sup>®</sup> 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<sup>®</sup> film, RB2 Coating, RSV<sup>®</sup> and RUV<sup>®</sup> 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.
Innovation in manufacturing involves a spectrum of evolutionary improvements resulting in what West’s partner Daikyo Seiko, Ltd. considers as “Absolute Quality.” Recent continuous improvement efforts helped Daikyo achieve even higher levels in cleanliness of elastomer products.<br />
As advancements in pharmaceutical technology increase in the use of automated injection systems for health care treatment, traditional glass vials, syringes and cartridges must withstand higher automated delivery forces and pressures. The fragile nature and dimensional variability in wall thickness of glass components may lead to breakage, which presents challenges to automatic administration systems.
<p>Tibor Hlobik, Director, Prefillable Solutions and Technologies<br />Mike Gills, Customer Technical Support Process Engineer</p><p>Growth in biopharmaceutical therapeutics is leading innovation with prefillable syringe systems. These complex sensitive drug products require highly inert primary packaging materials for improved stability and delivery in perfect quality for reduced safety risk. This <span style="text-decoration: underline; color: #0000ff;"><a href="https://www.westpharma.com/west-login">poster</a></span> will provide a quality comparison of primary prefillable syringe options including glass, coatings/laminates and cyclic olefin polymers, and highlight the findings of a case study comparing 1mL long syringe attributes.</p>
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