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Several important changes have been made recently in the United States Pharmacopoeia (USP): Chapter <381> was amended and new chapters <382>, <1382>, and <1381> were created. West has been aware of these changes and is prepared to address them from both a knowledge and a technology perspective.
Key elements of these changes are:
As a result, West is making changes to related quality certificates, which currently provide results for USP/EP combined chemical testing. As heavy metals and zinc belong to chemical testing, the reference to USP will be removed; testing will continue following EP 3.2.9 (Rubber Closures for Containers for Aqueous Parenteral Preparations, for Powders and for Freeze-Dried Powders). <381> heavy metals and zinc update will be effective 01-Dec-2020; functional testing will continue harmonization with EP 3.2.9 until the 2025 expiration.
Specific West components will be evaluated to demonstrate USP <382> compliance. Additionally, West will offer product packaging and delivery systems contract testing services for <382> compliance and <1382> compatibility through its Integrated Solutions platform. For more information, watch West's On-Demand webinar.
It is imperative for the pharmaceutical industry to be prepared to comply with new compendia chapters as soon as they are enacted. This comprises both knowing of proposed changes as soon as announced and being well prepared to accommodate them. USP Chapter <381> is changing, and Chapters <382>, <1382> and <1381> are being created. The Pharmacopeia Forum for final comments has been published.
It is imperative for the pharmaceutical industry to be prepared to comply with new compendia chapters as soon as they are enacted.<span> </span>This comprises knowing of proposed changes as soon as announced, and being well prepared to accommodate them.<span> </span>Expected to be implemented by late 2018 – the functionality tests section of USP Chapter <381> (<em>Elastomeric Closure for Injections</em>) will be removed, and greatly expanded functionality tests will be incorporated in new USP Chapter <382> (projected title: <em>Elastomeric Closure Functionality in Injectable Pharmaceutical Packaging/Delivery Systems</em>).<span> </span><p> </p>
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.
In recent years, there has been an increase in the use of multi-dose vials. First, multi-dose vials can create efficiency and reduce packaging waste when vaccines are administered to large populations. For example, both the Pfizer-BioNTech and Moderna COVID-19 vaccines provide multiple doses per vial to maximize the number of people vaccinated as quickly as possible. Secondly, multi-dose vials enable dosing flexibility to a diverse group of patients with different dosages dependent on patient age/weight. This also applies to the animal health sector to accommodate the large diversity across different species, dosage differences, and use of various needle gauge sizes.
On January 1, 2018, new USP standards became mandatory for measuring elemental impurities in pharmaceuticals and their ingredients – aligning with ICH Q3D, which provides limits for the amount of elemental impurities in drug products. New USP General Chapters, USP <232> (<em>Elemental Impurities – Limits</em>) and USP <233> (<em>Elemental Impurities – Procedures</em>) have replaced USP <231> (<em>Heavy Metals</em>). USP <231>, which historically was used to test for heavy metals in drug products as well as packaging components, has been withdrawn. However, the heavy metals testing in USP <381> (<em>Elastomeric Closure for Injections</em>), which is used for testing of elastomeric closures, still references USP <231>.
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