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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.
This upgrade is just one piece of the comprehensive quality improvements that have enabled Daikyo to provide customers with a new portfolio of elastomer packaging components that are high-quality formulations with proven critical control that helps to prevent rejects and ensure reliability.
Introducing Daikyo D Sigma® Stoppers
Daikyo D Sigma (DΣ)® elastomer components were developed to exceed the ever-increasing demands of the pharmaceutical industry’s drive toward closures that are “essentially free” of particulate and meet customer demand for consistency by assuring dimensional stability. Particles and dimensional defects in primary packaging can have significant impact on end-of-line rejects, reducing yield and affecting patient safety. DΣ elastomer products are controlled for particulate and dimensions to minimize part-to-part variability and provide risk mitigation to meet the growing quality needs of the pharmaceutical industry.
DΣ elastomer components combine several critical quality attributes, starting with the tightest particulate specification in the Daikyo portfolio. Lot to lot sub-visible and ISO 8871-3 compliant visible particulate testing provides quality attributes defined by industry-settled assurance methodology. Also, every DΣ component is verified by vision inspection at 0.01 mm2. Finally, the use of in-line, 100% automated control of critical-to-function dimensions reduces risk of variability and results in the adoption of more restrictive AQL criteria. When combined with well-established Daikyo Flurotec® barrier film, DΣ elastomer components provide the highest-quality solution to the challenges associated with today’s high-value injectable drugs.
Join West and Daikyo for the DΣ elastomer components launch at the CPhI conference in Madrid, October 9-11, 2018! Daikyo DΣ formulation D21-7S will be launched in a small, ready to use, sterile pack format. Customers will now be able to purchase Daikyo RUV® stoppers in packs of 1,000 and 500 units respectively for 13mm and 20mm serum and lyophilization (coming soon) configurations.
To learn more about this latest component offering, contact your Account Manager or Technical Account Specialist.
Flurotec™ technology is licensed from Daikyo Seiko, Ltd.
Flurotec™, Daikyo D Sigma ® and Daikyo RUV® are trademarks or registered trademarks of Daikyo Seiko Ltd.
Historically, finding suitable containers for complex protein drug products has been difficult, since interaction with elastomeric closures can result in particle formation. These particles indicate an underlying change within the drug product, undermining integrity and risking patient safety. The correlation of silicone coatings with protein aggregation has made some wary of their use; however, an elastomeric closure with no coating or film can be difficult to process. Another concern is that leachables originating from the elastomeric closure can induce particle formation.
<p>In <a href="/zh-cn/blog/2017/june/corporate-responsibility-for-2016">Part 1</a> of this blog series, we highlighted the Compliance and Ethics section of West’s inaugural Corporate Responsibility Report. </p><p>In Part 2, we will cover West’s commitment to serving the communities in which we live and work.</p>
West has recently converted its Elastomer Formulation Drug Master Files (DMFs) to an electronic (eCTD) format.
The Food and Drug Administration (FDA) is announcing the fee rates and payment procedures for medical device user fees for fiscal year (FY) 2019. The Federal Food, Drug and Cosmetic Act (FD&C Act), as amended by the Medical Device User Fee Amendments of 2017 (MDUFA IV), authorizes FDA to collect user fees for certain medical device submissions and annual fees both for certain periodic reports and for establishments subject to registration. This notice establishes the fee rates for FY 2019, which apply from October 1, 2018, through September 30, 2019.<br />
An extraction study is sometimes thought of by customers as an expensive and time-consuming exercise for filing. However, extractables studies are more than that. Performing an extraction study provides a thorough understanding of the materials used. It is a study that takes into account the primary packaging components and provides an understanding of the chemical species that may potentially come out over the shelf-life of a product.
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