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
4040 LyoTec® Lyophilization Stoppers: Forward Thinking Innovation Combines Demonstrated Design Success with Expertise in Testing and Raw Material Selection
West Pharmaceutical Services, Inc., a global leader in innovative solutions for injectable drug administration, has released its 4040 LyoTec® Westar® Select Ready-to-Sterilize (RS) and Ready-to-Use (RU) Lyophilization Stoppers, the first components of a portfolio of vial closures to be developed using West’s new state-of-the art elastomer formulation, 4040/40 gray. By combining the demonstrated success of an established design and significant levels of expertise in testing and raw material selection, we have achieved improvements and optimized benefits across the spectrum of packaging attributes required for performance, quality, and safety of the packaging and delivery of lyophilized drug products.
Combining a breadth of historic knowledge with forward thinking best practices.
Quality by Design
The Quality by Design (QbD) principles are part of a proven practice of “starting and ending” with the customer’s needs in mind. With almost 100 years of experience in the parenteral drug packaging and delivery industry, West is uniquely positioned to leverage that experience and develop new elastomer components to meet the current and future needs of our customers and the patients as regulations continue to evolve.
Using a QbD approach brings us a deep understanding of the materials used for our primary closure components. This helps us reduce risks that may be posed to drug product quality by the closure. For 4040 LyoTec, “beginning with the end in mind” meant that all packaging and delivery decisions were directly related to the drug product quality and user/patient needs. Patient needs were incorporated into the drug product requirements, which were then cascaded to help define the packaging and delivery needs, making sure to always be inclusive of the elastomer configuration.
We have plans to do a deeper dive into the QbD process in another blog later this year, so make sure to check back later or subscribe here so that you get it sent right to your inbox as soon as it’s published.
4040/40 Elastomer Formulation
Launched in 2021, the 4040 formulation was developed using not only QbD principles, but also a strong understanding of the increasing testing and quality demands and regulatory scrutiny for injectable drug packaging. This includes the formulation chemistry, extractable profile, and risk mitigation for raw materials. Intentional focus on formulation methodology and optimization of processing parameters means mitigation of risks from particulates, extractables, and coring and fragmentation. It also means more efficient drying following stopper processing. We also focused on creating contingencies to mitigate risk due to raw material supply changes.
Forward thinking Extractables and Leachables profiling
Informed by West’s considerable expertise in extractables and leachables testing, a forward-thinking approach was also taken to support our customers’ evaluation and use of the 4040 LyoTec stoppers. We first performed extensive material characterization studies to identify potential leachable substances using a wide range of drug solvent systems, and then also studied the leachables profile of 4040 LyoTec stoppers versus comparator stoppers in partnership with Lyophilization Technology, Inc. (LTI). This simulation study is ongoing and evaluates the stopper leachables over time observed in both a mannitol lyo cake as well as a sorbent.
Our findings so far support our goal to reduce extractables to the lowest possible levels when compared to legacy rubber formulations, ultimately providing our customers with both a high-quality product and the supporting data to meet regulatory requirements.
Using FluroTec® barrier film on the top surface to prevent sticking to the lyo shelves and B2-coating result in minimized clumping or sticking of stoppers in the feeder bowl and smooth tracking with continuous flow of stoppers along the rails. Previously only offered in 4432 and 4416 formulations, being able to offer this design in our new 4040 formulation presents our customers with an exciting new option. 4040 LyoTec stoppers have a single-vent design that effectively minimizes twinning, an event where two stoppers interlock with each other, and one that can cause costly backups on packaging line. They are offered in both ready-to-sterilize and ready-to-use options and available in both 13mm and 20mm sizes for additional convenience and flexibility.
Besides having a naturally low level of particulates resultant, the 4040/40 formulation also has benefits specific to lyo applications. Like many of our existing elastomers, it is compatibility with steam sterilization or gamma irradiation (< 45 kGy), providing helpful processing flexibility (see our TR 2021/238: 4040/40 Lyophilization Stoppers - Aging and Gamma Irradiation Study); it also been optimized for drying efficiency to improve steam sterilization throughput and boasts a residual moisture content for ready-to-use (steam sterilized) stoppers of ≤ 0.2% water, currently the lowest of any West lyophilization stoppers.
The bottom line
West’s new 4040 LyoTec stoppers use a state-of-the-art 4040 formulation developed with multi-dimensional elastomer expertise and a quality by design development approach. In doing so, we have achieved a broad range of improvements and optimized benefits required for manufacturing performance, functionality, quality and safety, enabling our customers to confidently deliver their drug product to patients in the safest and most effective way possible.
West’s products are sold on the basis that it is the customer’s responsibility to evaluate and test the West product to determine its compatibility with other materials and fitness for any end use. WEST MAKES NO WARRANTIES, WHETHER EXPRESS, IMPLIED OR STATUTORY, INCLUDING, WITHOUT LIMITATION, THE WARRANTIES OF MERCHANTABILITY AND FITNESS FOR PARTICULAR PURPOSE, RELATING TO THE INFORMATION ABOVE.
LyoTec®, Westar®, and FluroTec® are trademarks and registered trademarks of West Pharmaceutical Services, Inc., in the United States and other jurisdictions. FluroTec® and B2-coating technologies are licensed from Daikyo Seiko, Ltd.
In 2012, West rolled out a new global branding initiative that included a new tagline: By Your Side for a Healthier World<sup>TM</sup>. What does that mean? Every day, injectable drugs and vaccines are administered to improve the health of millions of patients around the world. And every day, West works by the side of its health care partners to design and manufacture drug packaging and delivery systems that will bring those drugs and vaccines from concept to the patient more efficiently, reliably and safely. This has been West’s legacy since the Company was founded in 1923.
On 9 November 2017, West officially opened our recently expanded Kiefernweg Campus in Eschweiler, Germany, which includes a new global center of excellence for the research and development of pharmaceutical packaging components and systems for injectable medicines.
In the biologics space, there are clear trends toward higher delivery volumes, less frequent dosing, and the conversion from intravenous to subcutaneous delivery. This is driving demand for wearable technologies. Read more below about the FDA’s Patient-Focused Drug Development (PFDD) Initiative and how these findings can enable more insightful patient offerings.
The manufacture of polymer containers for parenteral drug products differs from that of glass and elastomers and must combine the common manufacturing methods below to meet the needs of the pharmaceutical market.
With the continuous progress in medical science and technology, drug evaluation criteria in China are also changing and improving. In the past, drug evaluation criteria did not require generic drugs to have the consistent quality and efficacy of innovator drugs; so some had a gap in efficacy. Since 2015, the National Medical Products Administration of China (NMPA), formerly the China Food and Drug Administration (CFDA), rolled out the Generic Quality and Efficacy Consistency Evaluation (GQEC) to improve the quality and efficacy of generic drugs. Generic drugs whose quality and efficacy are deemed equivalent to innovator drugs will enjoy preferential treatment in public hospitals and prescriptions.