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The heavy metals tests section <381> (Elastomeric Closure for Injections, Heavy Metals) and Extractable Zinc have been removed. Testing to address extractable elements has been added to the guidance section under <1381> (Evaluation of Elastomeric Components Used in Pharmaceutical Packaging/Delivery Systems). The goal of the testing is based on risk, and therefore the requirement has been made a guidance – this is a significant change. West has developed extraction and analytical methods that are incorporated in <1381>. This work was performed on multiple elastomeric formulas. If support is needed, West can very well navigate through this guidance and perform required tests.
The functionality tests section of <381> (Elastomeric Closure for Injections, Functionality Tests) have not changed and is proposed to be omitted after 5 years to allow industry to adequately implement USP <382>. Greatly expanded functionality tests will be incorporated in <382> (projected title: Elastomeric Component Functional Suitability in Parenteral Product Packaging/Delivery Systems). Chapter <382> will address fitness-for-intended-use functionality requirements for the following packages and delivery systems: (a) vial and bottle systems, prefilled and single use syringe systems, blow-fill sealed containers, dental cartridges for local anesthesia, pen injectors, and plastic containers for IV’s; (b) corresponding elastomeric components; and (c) corresponding drug products. Functionality tests proposed are syringe plunger break force, glide force, and plunger seal integrity, as well as syringe tip cap and needle shield tests.
Note that <382> is not self-contained – it will incorporate elements of <1382> (projected title: Assessment of Elastomeric Component Functional Suitability in Parenteral Product Packaging/Delivery Systems).Chapter <1382> will include discussion of fitness-for-intended-use testing, with guidance for test sample preparation, test population, procedures, data interpretation, sample sizes, and reporting. <1382> also will contain many relevant ISO references and necessary details regarding functional testing specifications and general product knowledge expectations.
These changes are intended to enhance patient safety by reducing risk through more thorough product understanding – through increased focus on testing of packaging and delivery systems, including elastomeric component interactions with multiple interfacing components and with drug products.
West continues to focus on understanding the latest in the ever-changing regulatory landscape in its goals to be first-to-market with knowledge and advanced testing capabilities and methods to increase value to customers, but most importantly, reduce risk to the patient.