We apologize your item could not be found. Not all items are listed on our website. Please contact your account manager for details regarding your searched item.
Material number (eg: xxxxxxxxxxx) no space or hyphen needed.
No Results Found
Have you ever faced the need to identify a primary package for your drug product, but do not know where to start? Are you faced with tight timelines and component data constraints when evaluating stoppers, seals, and vials for container closure systems (CCS)? Do you need the right data for regulatory filing to support the choice of CCS for your drug product?
If you said yes to any of these questions, West Pharmaceutical Services, Inc. (“West”) can help! West has developed the DeltaCube™ Modeling Platform to address these questions and mitigate issues during the early phase of your stopper, seal, and vial selection. The DeltaCube™ Modeling Platform is an online, subscription-based, modeling tool that provides a data-driven systems approach to guide component selection. Using real dimensional data captured at the individual part level, not general engineering specifications or summary statistics such as averages and variances, the DeltaCube™ Modeling Platform can rapidly evaluate multiple sets of stoppers, seals, and vials at one time over a range of stopper compressions to select optimal CCS components.
The pharmaceutical and biotech industries face many challenges when selecting the appropriate stopper, seal, and vial combination for a drug product. It is important to understand the parameters that can affect which stopper, seal, and vial are selected for a CCS in order to minimize container closure integrity(CCI) issues, which put a CCS at risk for sterility problems. The DeltaCube™ Modeling Platform currently focuses on dimensional fit, computing at any desired stopper compression the amount of metal available to crimp. This is known as the seal skirt overhang length (SSOL). Based on the SSOL range and compression selected, a rapid evaluation of up to four combinations of stopper, seal, and vial can be made at one time. Additionally, as West has seen many times, assuming that a CCS used for a previous drug product will work for a new drug product can be a risky decision, especially when each drug product has very different storage conditions. The DeltaCube™ Modeling Platform can help here as well, computing the probability of maintaining the necessary SSOL range once the proper compression to maintain CCI has been identified.
One important aspect of understanding CCS components is to work with your supplier and collect as much information as possible to aid stopper, seal, and vial selection. But how do you get this information, and how much are they willing to share? Relying on limited data sets, such as only those provided in component drawings, is risky. Drawings are limited in scope, displaying product specifications, but not real manufacturing data, and may not be a true representation of the component dimensional trends. Traditional stack-tolerance analyses, based on product drawings and engineering specifications, typically reveal one or more of the evaluated CCSs failing to meet the desired SSOL. Without the ability to quantify or estimate the probability of failing to meet the required SSOL range, it is difficult to properly gauge the risk associated with a CCS. The result is generally unexplained spikes in rejects over time, leading to potential destruction of finished product and lost revenue despite all CCS components being within specification.
Previously, there was no way to distinguish between components with the same specifications, leading to trial-and-error approaches which were time consuming and costly. With the DeltaCube™ Modeling Platform, you can quantify the risk of failing to meet a desired SSOL range for any combination of stopper, seal, and vial. This is done using a combination of West’s historical product data for each recommended component, as well as your own imported dimensional data. By using real data, the minor differences between similar CCS components for an individual drug product can be captured and properly evaluated to identify potential problems before they occur.
The DeltaCube™ Modeling Platform, through a big data systems approach, was developed to reduce risk, accelerate development, and reduce the need for rework. The tool incorporates West's 95+ years of containment experience in addition to historical stopper and seal dimensional data. The DeltaCube™ Modeling Platform also allows subscribers to upload their own component dimensional data, enabling transparent and informed decision making. Moreover, West component data is continually updated through its Quality Management Systems, ensuring that the most up-to-date data and statistical distributions are always available for all West recommended components.
West also provides support through testing services such as dimensional analysis, packaging material characterization, engineering fill-finish capabilities evaluation, residual seal force testing, and CCI testing, to name a few.
By using the DeltaCube™ Modeling Platform you can make a faster decision on the best container closure system, allowing you to reduce the number of CCSs you need to test and reducing your process development timelines. In better understanding your components’ variabilities and the system fit, you reduce the chance of rework due to those variabilities. In addition, by using the DeltaCube™ Modeling Platform's unique snapshot-in-time approach for evaluating components, it is possible to compare component dimensional data over time, which can be used to anticipate and prevent spikes in product reject rates.
Click here to learn more about West's new DeltaCube™ Modeling Platform and how it can help you select the right CCS for your drug product, reduce process development timelines, mitigate risk, and provide supporting data for your regulatory submission!
DeltaCube is a trademark of West Pharmaceutical Services, Inc.
The pharmaceutical and biotech industries face many challenges when selecting the appropriate stopper, seal, and vial combination for a drug product. Further compounding these challenges is the manufacturing capability of each component supplier. Lot to lot variation can result in components that had maintained container closure integrity (CCI) and visual acceptance during development unexpectedly failing during production. Therefore, it is important to take a system approach when selecting vial container closure system (CCS) components and designing a fill-finish process. To minimize the risk for sterility failure and maximize performance, it is essential to understand not just the process, but also the historical and trending performance of the selected parenteral packaging components. As a result, West has built the DeltaCube™ Modeling Platform to facilitate data-driven selection and optimization of vial CCS components.
When evaluating the vial system for your drug product, how do you know you’re making good decisions about protecting the drug product while also meeting regulatory expectations for data requirements as outlined in ICH Q9? To illustrate how complex it is to determine how much data is enough to make good, sound, decisions on your vial containment system, two 20mm container closure systems (CCS) were evaluated with the primary difference being the hardness of the rubber vial stopper. The designs were identical for each stopper, meaning the specifications, nominal dimensions, and other major features were the same.
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.
Selecting a container closure system (CCS) is an important part of the pharmaceutical commercialization process. It is important to ensure that the components selected are compatible with the drug product to be packaged; however, it is equally important to ensure that the components are compatible with each other. Here we provide background on the importance of correct pairing between vials and stoppers and showcase <a href="/products/vial-containment-solutions/stoppers/4040-lyotec-lyophilization-elastomer-stoppers">lyophilization stoppers V-50-I (13mm) and S-87-I (20mm) in the 4040/40 Gray formulation</a> that can be paired with any vial blowback geometry.
Selecting the best vial container closure system (CCS) components and capping process for a drug product ensures optimal performance and patient safety. An optimized CCS requires compatible components (rubber stopper, aluminum seal, glass or polymer vial) and proper capping setup. This provides predictable sealing performance, which maintains the container closure integrity (CCI) needed for patient safety and visual acceptance.
English
Chinese
