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There is an increasing trend in the pharmaceutical industry for ready-to-use components for a variety of reasons.
As a result, customers are looking to their manufacturing suppliers to help them address the following challenges:
Daikyo RSV (ready-to-sterilize validated) and RUV (ready-to-use validated) components allow customers more time to focus on their own drug manufacturing needs. Daikyo RUV components are delivered to customers ready-to-use on their filling lines. The components are manufactured using high-quality elastomer formulations, pharmaceutically washed, 100% camera-inspected and steam sterilized. The Daikyo RUV process is fully validated, filed in Drug Master Files in the U.S. and Canada, and utilizes an overkill method based on ISO 17665-1 to provide a sterility assurance level (SAL) of 10-6 or better.
Each batch of product is provided with specification for bioburden, particulate and endotoxin. Daikyo RUV components adhere to rigorous quality standards and provide customers regulatory acceptance and flexibility.
Additionally, the RUV offering is available in small quantities to meet your clinical trial and scale-up needs and enable manufacturing flexibility.
To learn more about the latest component offering from West, click here to learn more about Daikyo RUV components or contact your Account Manager or Technical Account Specialist for more details.
<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.
Last week, West once again exhibited at CPhI/Innopack—Europe’s premier trade show that brings together approximately 36,000 senior pharmaceutical professionals from more than 150 countries. West was among the show exhibitors that included providers of packaging, finished doses, machinery, ingredients, contract services, and other related services.
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 />
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.
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