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
Your Password has changed! Please login again
Cart
Outdated Browser Detected
Our website has detected that you are using an outdated browser that will prevent you from accessing certain features.
Please use one of the below recommended browsers to improve your browsing experience
Scientific Insight Enables Risk Mitigation: Why West is By our Customers’ Side
As regulations increase across the pharmaceutical industry, reliable scientific evidence is needed to support the decisions being made during the drug development process in order to achieve the safe delivery of medicines to patients.
Recent regulations around issues such as particulate and heavy metals, require a strong understanding of the testing and analysis to move drug products to the market.
Collaboration with strategic suppliers is critical to managing issues associated with bringing a sensitive drug molecule to market. By supporting our customers from molecule to market, West works to build a close partnership that can provide the scientific analysis, data and regulatory support needed to mitigate risk, speed drug development, and get drug products to market to support patient health.
No matter what challenges our customers face during the drug product life-cycle, chances are West has faced them before. With nearly a century of industry leading experience, West may already have the answers you need, and if not, we can develop a scientific approach to find what you’re looking for. Working together, we can address issues quickly and effectively, helping to mitigate risks as early as possible in the development process by helping customers navigate regulatory and technical challenges.
To learn more about how West can help, check out our video here on our Integrated Solutions Program page.#WestByYourSide
When converting a drug product from its initial container closure system to a prefillable syringe system or device, component elastomer formulations and sterilization mode equivalency can help ease the transition, minimize regulatory filing times and mitigate risk for pharmaceutical manufacturers.
“Retro.” “Vintage.” “Nostalgic.” These can be great terms to describe that classic car you have your eye on, but they are not great when describing your primary drug product packaging. Many of today’s drug products are still packaged with elastomer formulations and designs that were first developed over 50 years ago.<span> </span>Generic companies that simply replicate the innovator packaging could be affecting their operation negatively for many more years to come.<span></span><p> </p>
This is a very common statement that we hear in the Technical Customer Support (TCS) group. There are many things to consider when choosing the right component for a drug application. Just like a drug product, different ingredients are used to make the material for an elastomeric component. Each of the ingredients has a specific role to play in the functionality of the component, but also may pose a potential risk to the drug product.
<br />In 2016, the China Federal Drug Administration (CFDA) made two announcements regarding packaging of parenteral drug products. Per these announcements, stability studies of packaging materials should refer to protection, compatibility, safety and functionality properties.
Container closure integrity (CCI) is a fundamental requirement of every sterile drug package. Recently, the United States Pharmacopeia Convention (USP) published a guidance in this area that, among other key topics, addresses test methods in detail: Chapter <1207> Package Integrity Evaluation – Sterile Products. However, proper test method is only one aspect of achieving good CCI.