USP 381 Test Standard for Elastomeric Caps for Injections

EUROLAB, with its state-of-the-art accredited laboratories and expert team, provides precise and fast testing services within the scope of USP 381 testing. USP section 381 defines standards for functionality testing of valves intended for puncture with a hypodermic needle: Penetrantability, Fragmentation, and Self-Close Capacity, as well as biological and physiochemical testing.

Such closures are typically used as part of a vial, vial, or prefilled syringe package system. This section specifies test limits for Type I and Type II elastomeric closures formulated with natural or synthetic elastomeric materials. Type I caps are used for aqueous preparations. Type II closures are typically designed for non-aqueous preparations.

The functionality tests cover the requirements for the cap, both sent by the cap supplier to the injectable product manufacturer (end user) and for the cap ready for end use by the end user. It is important to document the full description of the elastomer and the closure being tested, including the lubrication, coating, lamination or treatments applied.

Caps are made from a wide variety of elastomeric materials and optional polymeric coatings. It is therefore beyond the scope of this section to specify identification tests that cover all possible closing presentations. However, it is the responsibility of the closure supplier and the injectable product manufacturer (end user) to verify the closure elastomeric formulation and any coating or laminate materials used against appropriate identification tests.

Examples of some analytical test methodologies that may be used include specific gravity, ash percentage analysis, sulfur content determination, FTIR-ATR testing, thin layer chromatography of an extract, UV absorption spectrophotometry of an extract, or IR absorption spectrophotometry of an extract.

EUROLAB assists manufacturers with USP 381 test compliance. Our test experts, with their professional working mission and principles, provide you, our manufacturers and suppliers, the best service and controlled testing process in our laboratories. Thanks to these services, businesses receive more effective, high-performance and quality testing services and provide safe, fast and uninterrupted service to their customers.