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A good elastomer stopper for a vial container system needs to have the right properties. These properties are largely determined by the elastomer formulation, which comprises the base elastomer, fillers, plasticizers, and curing agents. The interplay among these components is crucial, as they determine performance. For example, hardness is affected by filler type and level, as well as by curing agent and level. West understands these issues, and therefore is able to develop formulations to offer maximum performance. An example is the formulation 4040/40, which was designed according to quality-by-design (QbD) principles.
Performance evaluation is governed by standards published by organizations such as International Organization for Standardization (ISO), United States Pharmacopeial Convention (USP), European Directorate for Quality of Medicines (Ph. Eur.), and China National Medical Products Administration (NMPA). Key properties of a stopper are:
Acceptable performance depends upon the standard considered, and the drug product for which the stopper is being used. West Analytical Lab Services has the staff, knowledge, and facility to perform evaluations according to all the standards cited, and offers testing through its Integrated Solutions platform.
Click here for more information on our 4040 LyoTec® stoppers.
Selecting the right stopper and making the right evaluations – West has the expertise. For more, contact an Account Manager or Technical Customer Support (TCS) representative.
LyoTec® is a registered trademark of West Pharmaceutical Services, Inc. in the U.S. & other jurisdictions.
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.
United States Pharmacopeia (USP) requirements for elastomeric components of container closure systems used for parenteral products are changing. The original USP chapter for elastomeric components used in injectable drug packaging was <381> Elastomeric Components in Injectable Pharmaceutical Production Packaging/Delivery Systems. This addressed characterizing for biological reactivity, physicochemical testing and functionality testing and compliance was typically a supplier responsibility. The new chapter, USP <382> Elastomeric Component Functional Suitability in Parenteral Product Packaging/Delivery Systems, will become effective on December 1, 2025. This will update the functionality tests for elastomers, whereas the functionality testing portion of USP <381> will be omitted. Under the new chapter, it will be the drug manufacturer’s responsibility to meet the functionality requirements on the final system.
When it comes to choosing the right container closure system, a significant amount of focus is directed at addressing issues that may be a risk to safety and efficacy of the parenteral drug before it is introduced to a patient. Examples are testing of container closure integrity (CCI) and drug stability. Prior to drug administration by a health care professional, the rubber stopper is pierced with a needle, at least once. Stopper puncture testing also needs to be considered, especially if the closure system will be used in a multi-dose application.
When selecting the appropriate rubber stopper for any respective vial containment system, there are many aspects to consider regarding the properties of the elastomeric closure. For the purposes of this discussion, the focus will be on the functional performance of the stopper and what key aspects should be considered during the assessment and selection process. Coring and fragmentation, container closure integrity, and machinability of the stoppers will be briefly reviewed.
In its 95+ year history, West has developed and marketed a very large number of elastomeric formulations, each designed to address particular market demands. Over this time, various aspects of drug product quality have gained attention – a fact reflected in the numerous regulatory guidances that have been issued. An early focus of these guidances was extractables and leachables, followed closely by particulate matter and container closure integrity. Beyond these regulatory requirements, the market demands product portfolios that enable platforming and predictable, consistent product quality and performance.
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