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The process of crimping an aluminum seal onto a pre-stoppered vial should not be overlooked or underemphasized. Within the pharmaceutical industry, there is a need for an elegant and effective seal not only from the cosmetic perspective, but also more importantly, because of the correlation between seal quality and container closure integrity. Even in laboratory settings and during early-stage evaluations of a drug product and containment system, reliable, robust and consistent crimped seals are necessary.
Historically, issues can arise due to unoptimized crimping processes or equipment. Often the use of jaw-type crimping devices can generate defects due to the dimensions of the jaw head not being appropriate for the vial, stopper or seal. Also, if the downward pressure onto the vial is not appropriate or uniform, a defect can result from the jaws prematurely squeezing the skirt prior to being in the desired position of the vial crown. If a jaw-type crimper must be used, the recommendation is to have a unique jaw-head change part for each combination of vial, stopper and seal. In addition, downward pressure must be optimized.
West does not recommend the use of jaw-type crimpers. Disc-style crimping offers a more consistent, commonly used method. In this method, a pressure block applies an appropriate and uniform pressure onto the vial, stopper and seal. A disc then gently and consistently tucks the aluminum under the flange of the vial crown, securing the seal. Properly sealed vials are essential as they help to achieve that highest objective – patient safety.
Courtesy of Bausch + Ströbel
For additional information regarding industry available disc-style crimpers, such as bench-top units or large-scale machines, please contact your Account Manager or Technical Customer Service Representative.
The International Conference on Harmonisation (ICH) has issued <em>Guidelines for Elemental Impurities</em> to limit patient exposure to potentially toxic elements above a specified limit during their course of treatment.
<p><span>Anti-VEGF therapeutics for the treatment of ophthalmic conditions such as neovascular (wet) age-related macular degeneration (AMD) and diabetic macular edema (DME) have significantly improved patient prognoses, in some cases preventing or reversing progression to blindness. Routine injections into the eye of recombinant protein drugs such as bevacizumab, ranibizumab or aflibercept have proven to be efficacious in neutralizing the binding of over-expressed vascular endothelial growth factor (VEGF) proteins to their corresponding cellular receptors, thus interrupting the angiogenesis signaling pathway which otherwise leads to the disease states. In short, anti-VEGF injections are preventing or restoring vision loss for millions of people world-wide.</span></p>
In China, the industrial and regulatory landscape has been evolving rapidly – and in particular as it relates to generic drug products. In 2015, the China State Council announced Opinions on Reforming the Review and Approval System for Drugs and Medical Devices (No. 44). At this same time, a series of reforms were announced by the National Drug Administration of China (formerly the China Food and Drug Administration, CFDA) to upgrade the pharmaceutical industry by raising marketed products to international standards in terms of quality, safety and efficacy.
This past February, our team members around the world came together to help fight hunger in their local communities during our fifth annual global food drive. As the global community navigates the evolving challenges of the COVID-19 situation, having a stable food supply is even more important. We are proud of our team members for their incredible generosity. Their donations are needed now more than ever.
West is proud to announce that we have published our 2021 Corporate Responsibility (CR) Report, Purpose. Driven., which is now available on <a href="/about-west/corporate-responsibility">West’s website.</a> <br />This is West’s 6<sup>th</sup> annual CR Report, and highlights ESG successes from over the past year, including progress on environmental sustainability goals, diversity and inclusion, and success around the Company’s philanthropic efforts. The publication also highlights some of the recognition received for our ESG (Environmental, Social, Governance) performance, including placement in Barron’s Top 100 Most Sustainable Companies, Corporate Social Responsibility Programme of the Year from Pharma Industry Awards in Ireland, and a Silver Stevie Award for Corporate Social Responsibility.
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