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Drug developers must understand and mitigate the risk of various chemical entities (leachables) migrating from any material that comes into contact with their drug product. Failure to execute an appropriate extractables and leachables assessment could lead to failures in meeting agency expectations and a delay in drug development timelines.
In an effort to help our customers navigate regulations and agency expectations without hindering drug development timelines, West Analytical Services has developed two unique tools, VeriSure® Technical Packages, specifically for our 4023/50 Gray and 4432/50 Gray formulations and E2L testing services to support their extractables risk assessment. These tools can help customers move efficiently through the first stage of the extractables and leachables process for their packaging components.
The VeriSure technical packages provide comprehensive technical information for extractables which customers can access online once purchased. The package is a semi-qualitative collection of results obtained from years of data and studies for these formulations. Extractables data is acquired using multiple solvents, extraction conditions and analytical techniques.
The E2L testing is a service that provides a risk assessment for extractables to determine what leachables a manufacturer may want to focus on for their leachables studies. Although our E2L testing assists our customers with their risk assessment, it does not remove the need to perform a risk assessment for leachables specific to their drug products. Analytical Services can also provide the E2L risk assessment for any extractables services and not just those related to the VeriSure technical packages.
Interested in learning more? Download a case study focused on a biopharma company who used West’s VeriSure technical package to initiate a successful extractables and leachables assessment, preventing a delay of a critical submission.
VeriSure® is a trademark of West Pharmaceutical Services, Inc., in the United States and other jurisdictions.
West has announced a new online resource center to assist pharmaceutical and biopharmaceutical manufacturers as they prepare for the industry’s revised standard regarding labeling for cap overseals and ferrules on injection vials, United States Pharmacopeia (USP) General Chapter <1> Injections, Labeling on Ferrules and Cap Overseals (USP 34-NF 29 November 1, 2010).
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.
West Pharmaceutical Services Brazil is pleased to host the VII Technical Symposium on October 28, 2014, at the Melia Hotel Jardim Europa in Sao Paulo, Brazil.
Combination products open up new vistas when it comes to delivering innovative therapies to patients in need, but teams bringing these products to the market face a number of significant hurdles. Recent surveys conducted by West at workshops held in PA and AZ have revealed some of our customers’ biggest challenges. This is the first of three blogs focused on these challenges — and how West can help Simplify the Journey™ when it comes to developing a combination product.
Subvisible particulates (defined as those in the 0.1-10 micron range) are a growing concern for injectable drug manufacturers. The particles may cause aggregation, which can impact the drug product and create a potential safety risk for the patient. To help ensure product quality, the U.S. Food and Drug Administration recommends that manufacturers gain a better understanding of how subvisible particles impact the drug.
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