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It is imperative for the pharmaceutical industry to be prepared to comply with new compendia chapters as soon as they are enacted. This comprises knowing of proposed changes as soon as announced, and being well prepared to accommodate them. Expected to be implemented by late 2018 – the functionality tests section of USP Chapter <381> (Elastomeric Closure for Injections) will be removed, and greatly expanded functionality tests will be incorporated in new USP Chapter <382> (projected title: Elastomeric Closure Functionality in Injectable Pharmaceutical Packaging/Delivery Systems).
Chapter <382> will address fitness-for-intended-use functionality requirements for the following packages and delivery systems: (a) vials, bottles, needle-based injection systems, blow-fill sealed containers, dental cartridges, pen injectors and plastic containers for IVs; (b) corresponding elastomeric components; and (c) corresponding drug products.Functionality tests are also proposed to include syringe plunger break force, guide force and plunger seal integrity as well as syringe tip cap and needle shield tests.Chapter <382> is not self-contained – it will incorporate elements of new USP Chapter <1382> (projected title:Assessment of Elastomeric Closure Functionality in Injectable Pharmaceutical 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, and reporting.Chapter <1382> will also contain many relevant ISO and USP references.
The sum of all these changes is to enhance patient safety – through increased focus on testing of packaging and delivery systems at a higher system-level, including elastomeric component interactions with interfacing components and drug products. West continues to have a laser-focus on understanding the latest in the ever-changing regulatory landscape and proud to be first-to-market with advanced testing capabilities and methods to best support customers.
For more information about current and upcoming industry guidance, please visit the Industry Trends/ Regulatory section of West’s Knowledge Center here.
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.
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.
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> <em>Elastomeric Components in Injectable Pharmaceutical Production Packaging/Delivery Systems</em>, which addressed characterizing for biological reactivity, physicochemical testing and functionality testing. The new chapter, <em>USP <382> Elastomeric Component Functional Suitability in Parenteral Product Packaging/Delivery Systems</em>, will become effective on December 1, 2025 and will update the functionality tests for elastomers, whereas the functionality testing portion of USP <381> will be omitted. While under USP <381> compliance was typically a supplier responsibility, under the new chapter it will be the drug manufacturer’s responsibility to meet the functionality requirements on the final system, including the container closure system and the drug.
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.
The American Association of Pharmaceutical Scientists (AAPS) held its annual meeting and exposition in Denver, CO from November 13-16. This meeting continues to be a major event in the calendar of pharmaceutical scientists in academia, the industry, government and research institutions who come to participate in training events and focus group meetings, hear subject matter expert presentations, and network with customers and suppliers at the 3-day exposition.
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