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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.
There are four key features that apply to every D Sigma stopper:
Every stopper has dimensions that are critical to the function of the packaging system. Ensuring these dimensions are correct allows for lower variability with more consistent and predictable product performance. Reliable machining in fill/finish operations, and maintaining proper container closure integrity, are examples of where dimensional measurements can have an impact. While most stoppers are inspected visually by operators on-line, or by lot sampling – often this is not adequate. D Sigma stopper dimensions are verified 100% by an in-line, automated, vision inspection system. This provides an increased level of confidence in packaging system performance.
D Sigma stoppers also have greater product consistency through the application of tight AQL’s, substantially raising the standard for product acceptance. Another feature is more extensive particulate testing, performed per ISO 8871-3 (Elastomeric parts for parenterals and for devices for pharmaceutical use -- Part 3: Determination of released-particle count). Enhanced vision inspection for foreign material as small as 0.01 mm2 is performed. Superior quality D Sigma stoppers, with well-established Daikyo elastomer formulations and Daikyo Flurotec® barrier film, are a solution to the constantly increasing quality demands of high-value injectable drugs.
To learn more about component offerings, visit our Daikyo D Sigma Stoppers page or contact your Account Manager or a Technical Account Specialist.
Daikyo D Sigma®, Flurotec®, DAIKYO RUV® and DAIKYO RSV® are registered trademarks of Daikyo Seiko, Ltd.
Administration of cell therapy drug products requires the delivery of cell suspensions without loss of function or viability. Cells must be transferred aseptically from their original container closure system to the administration system by infusion. However, the common transfer practice of using needles and syringes to pierce vial stoppers to retrieve contents poses a risk, namely needle-stick injury to clinicians.
The first thought that you may have when you hear the word “rubber” is natural rubber – a poly-isoprene-based polymer, which has as its origination the latex fluid drawn from rubber trees (most prominently in Indonesia and Malaysia). Although natural rubber has been used in the past for pharmaceutical applications, potential issues with latex allergies resultant from proteins from the original latex, have led to the almost complete adoption of synthetic rubber.<br />
Polymeric container systems are not new to the pharmaceutical industry, and their benefits in terms of break resistance, cosmetic quality and dimensional precision have been recognized by many companies around the world who have chosen to use a polymer vial or syringe.
Overview of EU GMP Annex 1<br />EU GMP Annex 1 is the European Union’s guidelines for good manufacturing practice (GMP) of sterile medicinal products for human and veterinary use.<sup>1</sup> It provides specific requirements for the manufacture of sterile medicinal products, including principles for cleanroom and clean zone design, personnel experience/qualification, and monitoring of manufacturing environments, just to name a few. The objective is to ensure product quality and potency, as well as patient safety, by minimizing risks of microbial, particulate and endotoxin/pyrogen contamination through manufacturing and environmental controls.<br />In August 2022, the final draft of EU GMP Annex 1 was released after years of development and took effect on 25 August 2023. In this blog, a summary of the key changes of relevance to primary packaging components and how West can help with the implementation will be discussed.
<em>Since 2007, West team members in Jersey Shore and Williamsport, Pa., have donated to Camp Victory, helping to beautify the grounds each year, build a wheel-chair accessible tree-house and provide funding for the summer camp experience of a lifetime for children with illnesses. For West’s Jeff Adams, </em><em class="ms-rteThemeForeColor-2-2">Supply Chain Manager/Lean Leader</em><em><span class="ms-rteThemeForeColor-2-2">,</span> Camp Victory has also been a place his family has experienced as both volunteers and campers.</em>
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