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West is pleased to announce that it will begin distribution of a new Daikyo offering – the DAIKYO PLASCAP® RUV one-step press-fit vial closure solution for serum applications. DAIKYO PLASCAP RUV features an integrated stopper and plastic cap, offered in nested configuration for small-batch filling. The closure system offers an alternative to aluminum seals.
In a recent press release, Karen Flynn, Sr. Vice President & Chief Commercial Officer at West noted, “From our long history as a trusted partner for pharmaceutical companies and emerging innovators around the world, we understand the challenges of bringing small batches of pharmaceutical therapies to market safely and efficiently. By offering single-step assembly for the flexi-filling and containment of injectables, the DAIKYO PLASCAP RUV closure is an ideal, high-quality and cost-effective solution. We are pleased to introduce the PLASCAP RUV closure as the latest offering from our collaboration with Daikyo Seiko, Ltd. to help customers mitigate drug product development risks and enhance patient safety.”
“PLASCAP provides manufacturers with a new closure system that integrates an elastomer closure in a plastic cap,” said Kunihiro Noto, Daikyo Seiko Managing Director. The closure is a revolutionary nested and sterile closure designed to be used with nested and sterile vials in compatible robotic filling systems. This enables conventional filling procedures including stoppering and capping to be done simultaneously. In addition to this convenience, PLASCAP eliminates the possibilities of aluminum particulate contamination. PLASCAP, manufactured by Daikyo’s technology with automation system in a clean manufacturing environment, is a key innovation in injectable packaging systems. We are proud to partner with West to contribute a next-generation solution to the pharmaceutical fill-finish process unit operations.”
Available in nested 13mm and 20 mm vial sizes, the DAIKYO PLASCAP RUV vial closure includes the following features:
For more information about DAIKYO PLASCAP RUV closures, click here.
PLASCAP® and Flurotec® are registered trademarks of Daikyo Seiko, Ltd. Daikyo Crystal Zenith technology is licensed from Daikyo Seiko, Ltd.
<p>Demand is increasing for Daikyo’s sterile, ready to use closure components, known as Daikyo RUV® (Ready to Use Validated) components. Against that background, Daikyo has significantly expanded its packaging component sterilization operations to meet the needs of smaller customers as well as large scale pharmaceutical companies. By adopting an approach that replicates its existing footprint, Daikyo has been able to manage validation risks effectively, while meeting an ambitious timeline for bringing on new autoclave capacity. The result of this expansion is a state-of-the-art facility that triples the company’s previous sterilization capacity.</p>
Small is the new big. Growth in specialty treatments that target smaller patient populations means less emphasis on economies of scale and more focus on adaptable and modular manufacturing.
Many parenteral drug products, such as monoclonal antibodies, are susceptible to degradation over time. To enable a longer shelf life, such drugs are often stored in a lyophilized state. Lyophilization (<em>freeze-drying</em>) is a process by which water is removed from a drug product. In the absence of water, all metabolic processes stop, making lyophilized drug products far more stable.
There is an increasing trend in the pharmaceutical industry for ready-to-use components for a variety of reasons.
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 from Daikyo focused on the manufacturing environment, including a move from ISO 8 to ISO 7 cleanrooms and 100% automated vision inspection with enhanced inspection limits. The result helped Daikyo achieve even higher levels in cleanliness of elastomer products.<br />
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