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
In December of 2025, United Stated Pharmacopoeia will make official the final version of USP <382> “Elastomeric Component Functional Suitability in Parenteral Product Packaging/Delivery Systems”, focusing on the functional testing of container closure systems. The tests in this chapter go beyond the current functional testing regimen in USP <381>, which is specific to the elastomeric component, the stopper, in a vial drug system. USP <382> broadens the scope of functional tests from only a stopper and vial to nearly all drug delivery systems. Additionally, drug manufacturers will typically need to perform the testing to show the functional suitability of the system, as the final configuration and use case will need to be known and established.
However, in USP <381>, the component supplier could perform the tests since they were system- and application-agnostic. Another major change is that the acceptance criteria will typically have to be defined and justified by the drug manufacturer based on the product risk assessment and use case. The goal of this is to ensure that the drug product guides how to test the drug system effectively and to what extent. West has published a series of blogs and a whitepaper to help our customers understand what is being asked of them in USP <382>:
The goal of the present blog is to address the frequently asked questions that West has received in relation to USP <382>, as drug companies are beginning to include the new testing requirements in their development programs.
USP <381> begins with a definition of a “packaging system”, but it very quickly focuses on the elastomeric component and describing how to verify that the elastomeric component meets the physiochemical, biological reactivity, and functional requirements. USP <382> takes a slightly different approach, which results in a vastly different way of thinking about the required testing program. USP <382> “addresses the fitness-for-intended-use functional suitability requirements of packaging/delivery systems…that include primary packaging components.” Per the chapter, the elastomeric component is only a piece of the overall container closure system, and the functionality of the elastomeric component can cover more than one functional parameter. Some examples of these varying functional areas are protecting the drug product, acting as a seal, and, in the case of dual chamber systems, keeping drug products separated. Based on what is contained in and the application of your packaging, your testing strategy around USP <382> could be different for each product. A deep understanding of the product’s use-case and application is a necessary first step in testing your container closure system effectively.
As mentioned previously, USP <381> focuses on the elastomeric component of the packaging system and sets baseline requirements for biological reactivity, physiochemical testing, and functional performance. USP <382> provides updated requirements for the functional evaluation of the elastomeric component, while keeping the biological reactivity and physiochemical testing in USP <381>. Therefore, functional testing in USP <381> will no longer be required and will be replaced by USP <382> after the official release.
In April 2025, a revised USP <382> draft was released that removed fragmentation from the standard, while keeping all other functional testing. There were concerns in the industry due to the fragmentation size limits that were applied: USP <382> counted fragments of size ≥150µm. This differed from USP <381> which counted fragments that were ≥50µm. Stakeholders in the industry pushed back saying that there could be a risk to patient safety by increasing the size threshold, while USP believes that due to the complexity of the tests, there is more opportunity for failure if the limit is set to ≥50µm from USP <381>. This could lead to widespread non-conformance and drug shortages. To compromise on this and not delay the release date of USP <382>, fragmentation was removed from USP <382> and remains in USP <381> until there are resolutions and revisions.
The scope of USP <382> has been broadened to capture many more drug packaging systems. Due to the complexity of drug products that have either recently hit the market or are in development, the approach needed to be updated to provide a standardized evaluation criteria for safety, quality, and compliance. The functional testing strategy has gone from only stoppers and only vials in USP <381> to a system view of stoppers and vials, blow-fill-seal containers, plastic infusion containers, cartridge and syringe systems, and single-use syringe systems.
Although West can characterize the performance of an elastomeric component in a specific container closure system, each drug packaging system has different applications and use-cases. In a vial system, for example, different Residual Seal Force (RSF) values and sterilization methods can be used depending on what the drug product requires. These variables present a challenge for the component supplier to test every potential use case. Therefore, for regulatory approval and ensuring system efficacy, the drug manufacturer needs to test their drug product and packaging components in the manner in which it will be used. The responsibility to verify product packaging performance has been effectively shifted to the drug manufacturer in USP <382>.
What tests should I select and what are the requirements?USP <382> provides the baseline tests depending on your container closure system’s clinical end use. Although the tests are well defined, there may be confusion around what acceptance criteria should be utilized. The standard lists the baseline requirements, but meeting these may not always be what is needed for to show system efficacy and compliance. For example, the baseline criteria in USP <382> Needle Self-Sealing Capacity for a vial and stopper system is a 21-gauge needle in a product-access application with three penetrations and still maintaining CCI per USP <1207>. If the drug product is meant for multi-dose applications beyond three, more penetrations will be required.
The final acceptance criteria for a drug product are based on the risk assessment and factor of safety the drug manufacturer deems appropriate, with a substantiated rationale. The rationale for the risk assessment is required for regulatory approval. This again points to the importance of understanding the application of the drug and drug delivery system.
To address this question, it is critical to remember that USP <382> is aligned to current ISO standards. USP <382> implies that companies will only need to evaluate commercialized products when changes are made to the components, processes, or product itself. However, the expectation is that marketed drug products released prior to the implementation of USP <382> were evaluated using ISO methods. If the testing strategy used in the original filing utilized ISO testing methodology, rationalized through a risk and science-based approach, and considered all applicable scenarios, then there could be justification that testing per USP <382> is not required and the manufacturer has demonstrated equivalence. More information on this question can be found in the blog “USP <382>: Think Systems, Not Components – Testing Drug Packaging and Delivery Systems – What You Need To Do”.
West has multiple teams and resources available to address your USP <382> questions. West Services and Solutions labs are fully equipped to test customer drug products according to USP <382>. Beyond having the equipment, lab members have a deep understanding of what is required in USP <382> and can guide customers to select the testing program to meet regulatory approval. Additionally, for any general or component related questions, please contact us here.
English
Chinese
