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Pharmaceutical drug development and commercial manufacturing is complex and risky. Packaging and drug delivery add challenges. With West by your side, you can find solutions to industry challenges such as:
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.
Welcome back to our continued deep dive into packaging components. In Part 1, we explored key regulatory frameworks that shape packaging components in pharmaceuticals, such as USP <382> (effective from 01 Dec 2025), EU GMP Annex 1, and EU Medical Device Regulation (MDR) 2017/745. These guidelines underscore the importance of ensuring packaging components maintain drug integrity and safety, focusing on aspects like functional suitability, aseptic processing, and comprehensive compliance documentation.
The field of cell and gene therapies (CGT) is advancing rapidly, with an increasing number of therapies receiving approval for various conditions, ranging from rare genetic disorders to more common diseases like cancer. As the scope of treatable conditions widens, there is a parallel demand for advanced drug delivery systems that ensure these therapies are administered safely and effectively.
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.
Welcome back to our continued deep dive into packaging components. In Part 1, we explored key regulatory frameworks that shape packaging components in pharmaceuticals, such as USP <382> (effective from 01 Dec 2025), EU GMP Annex 1, and EU Medical Device Regulation (MDR) 2017/745. These guidelines underscore the importance of ensuring packaging components maintain drug integrity and safety, focusing on aspects like functional suitability, aseptic processing, and comprehensive compliance documentation.
The field of cell and gene therapies (CGT) is advancing rapidly, with an increasing number of therapies receiving approval for various conditions, ranging from rare genetic disorders to more common diseases like cancer. As the scope of treatable conditions widens, there is a parallel demand for advanced drug delivery systems that ensure these therapies are administered safely and effectively.
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