We apologize your item could not be found. Not all items are listed on our website. Please contact your account manager for details regarding your searched item.
Material number (eg: xxxxxxxxxxx) no space or hyphen needed.
No Results Found
Testing the performance of your drug packaging and completing the Design Verification testing of your combination product.
Having a thorough performance dossier on your drug packaging or your combination product is a regulatory essential. With West, you are able complete your performance assessment.
Collaboration with customers, combined with a thorough understanding of current regulations, enables our analytical services team to create and execute robust study designs ensuring you have the data you need to provide to the regulatory agencies. These studies cover syringes, cartridges, vials and all related components, devices and combination products such as pre-filled syringes, auto-injectors and on-body delivery systems. West not only tests products but we also develop and manufacture components, devices and combination products as well as contract manufacture devices for the pharmaceutical industry. Our team of scientists, engineers, product developers, and regulatory experts empowers our laboratory services clients from the pharmaceutical industry in gaining regulatory approval for new products that deliver medications to patients safely and effectively.
While ISO and guidance documents suggest useful test methods to assess the performance of components and devices, the final collection of tests to be included in a regulatory filing must be based on Design Inputs and risk assessments. By partnering with West, you are able to put together a holistic risk-based testing program.
Cartridge and needle-based injection systems are covered by the ISO 11608 series of standards.
Ready-to-fill and pre-filled syringes are covered by the ISO 11040 Series of standards.
There are various standards that apply to different aspects of vial and bottle based primary packaging.
These devices can be treated as individual devices or as combination products, depending on how they are sold
Elastomeric Component Functional Suitability in Parenteral Product Packaging and Delivery Systems is a new USP chapter becoming effective in December 2025.
Laboratory filling of primary containers can be used to assess container-drug interactions.
English
Chinese
