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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.
The Exton West without Borders campaign came to a close with the annual picnic on Friday, June 3. This year the campaign benefitted the Leukemia & Lymphoma Society (LLS), one of the most respected organizations dedicated to finding a cure for blood cancers and providing important support services for those in our community affected by this disease.
Container closure integrity (CCI) is a fundamental requirement of every sterile drug package. Recently, the United States Pharmacopeia Convention (USP) published a guidance in this area that, among other key topics, addresses test methods in detail: Chapter <1207> Package Integrity Evaluation – Sterile Products. However, proper test method is only one aspect of achieving good CCI.
Regulatory agencies are driving the pharmaceutical industry to continuously improve the quality of drug products, but what is the reality for a drug developer who is expected to make parenteral preparations “practically free from particles”? Expectations of packaging are changing fast but how well prepared is the packaging to meet these needs?
The process of crimping an aluminum seal onto a pre-stoppered vial should not be overlooked or underemphasized. Within the pharmaceutical industry, there is a need for an elegant and effective seal not only from the cosmetic perspective, but also more importantly, because of the correlation between seal quality and container closure integrity. Even in laboratory settings and during early-stage evaluations of a drug product and containment system, reliable, robust and consistent crimped seals are necessary.
West and its partner Daikyo have introduced a superior quality elastomeric piston the Daikyo D Sigma<sup>®</sup> 1mL long piston, substantially raising the standard for product acceptance. The D Sigma piston combines Daikyo best practices with a known formulation (D21-7H), Daikyo Flurotec<sup>®</sup> film, RB2 Coating, RSV<sup>®</sup> and RUV<sup>®</sup> processing with key innovation improvements of automated dimensional measurements, tight Acceptable Quality Levels (AQLs), particulate testing per ISO 8871-3, and enhanced vision inspection to achieve high levels of performance and consistency.
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