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Putting together a risk assessment for nitrosamines in your final drug product is an extensive undertaking. Many contributing factors need to be considered, such as the drug substance’s manufacturing process, excipients, buffers, water, production equipment and environment, transportation conditions, packaging, and more. Within this scope, primary packaging components, such as elastomeric closures, also could contribute nitrosamines or precursors.
As the generation of nitrosamines depends on several different factors that are tightly bound to migration science, it is crucial to understand the scientific basis. Time and temperature play a role, but also material characteristics and chemical aspects. Not all elastomer components are the same. Given the variety of different formulations and their chemical complexities, and the progress in material development over the past decades, every elastomeric formulation can behave differently.
To address some of these aspects, we invite you to join our webinar given on August 27th 2020 discussing the involvement of elastomers in nitrosamine risk assessment. Please click here to register.
Understanding the different compendial and standards requirements, and how they influence the final delivery of parenteral drug products, is critical for ensuring patient safety. There are ongoing efforts to harmonize national pharmacopoeia and international standards, driven in large measure by the continuous technological developments in the pharmaceutical industry. Harmonization efforts can be treated differently depending upon the country and working group, and in some cases larger differences result. Staying aware of changes and differences can be a challenge.
Glucose monitoring, or measuring the amount of sugar in the blood, is a vital part of everyday care for those suffering from diabetes. Traditional tests require patients to prick their fingers and place a drop of blood on a test strip. The strip is then placed in a glucose meter that reports the results to the patient. While this test is very accurate, it offers a reading for only a single point in time. For patients to get a range of their blood glucose levels, more frequent data is needed at a variety of different times.
When choosing a resource for laboratory testing, pharmaceutical manufacturers face a difficult decision. Which is the better option – an independent facility or a supplier-affiliated laboratory?
We are very pleased to announce that two of our sites in Asia Pacific have received two additional safety accreditations recently, which further demonstrates and acknowledges our team’s continuous commitment to health, safety, and environment throughout West and the industry.
When evaluating the vial system for your drug product, how do you know you’re making good decisions about protecting the drug product while also meeting regulatory expectations for data requirements as outlined in ICH Q9? To illustrate how complex it is to determine how much data is enough to make good, sound, decisions on your vial containment system, two 20mm container closure systems (CCS) were evaluated with the primary difference being the hardness of the rubber vial stopper. The designs were identical for each stopper, meaning the specifications, nominal dimensions, and other major features were the same.
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