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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.
Take a look at our Extractables and Leachables analytical services offerings and see what else we can do to alleviate your E&L concerns.
LyoTec® Stopper Design
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.
Read more about how container closure integrity was evaluated using 4040 LyoTec stoppers with vials of three different blowback types in our technical report Evaluation of Container Closure Integrity for 4040/40 Lyophilization Stoppers.
Additional Lyo Benefits from 4040/40
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.
TR 2019/215: Evaluation of Removal and Insertion Force for 4040/40 Lyophilization Stoppers
TR 2019/215: Evaluation of Removal and Insertion Force for 4040/40 Lyophilization Stoppers (westdcxprod-eus-cd-internal.azurewebsites.net)
TR 2019/212: Evaluation of Needle and Vial Adapter Compatibility for 4040/40 Lyophilization Stoppers
TR 2019/212: Evaluation of Needle and Vial Adapter Compatibility for 4040/40 Lyophilization Stoppers (westdcxprod-eus-cd-internal.azurewebsites.net)
TR 2021/241: An Evaluation of Elastomeric Stopper Compatibility with Closed System Transfer Devices
TR 2021/241: An Evaluation of Elastomeric Stopper Compatibility with Closed System Transfer Devices (westdcxprod-eus-cd-internal.azurewebsites.net)
2 On Demand Webinars
Lyophilized Drug Product Case Study: Risk Mitigation of Primary Packaging through Physical and Chemical Testing(westpharma.com)
Choosing Optimized Packaging to Advance Lyo Drug Development (westpharma.com)
Take an in-depth look at the science behind containment & delivery of injectable medicines in the West Knowledge Center.