This presentation features testing overviews for container closures, pharmaceutical glass and plastic and covers common tests and techniques for each.
This article disucsses two trends turning the flowmeter industry on its ear: advances in flowmeter diagnostics and the adoption of smartphone-like technology to improve access and communications.
Strict regulations regarding the manufacture of HPAPIs require that pharmaceutical companies and CMOs carefully select equipment, outline processes and deploy appropriate containment strategies.
This paper focuses on how to enhance a pharmaceutical production facility's process safety with a dynamic checkweighing system.
Launching a product into Europe but unsure about the different requirements for a European market? Join our experts in September at our EU Product Launch Workshop series: Key timeline milestones from phase 3 to launch, where they will guide you through an EU product launch.
Avoid production quality-related issues by understanding and knowing how to identify the most common causes of punch tip edge wear.
Done correctly, Process Characterization reduces the risk of manufacturing failures and regulatory delays. Scientists at the AbbVie Bioresearch Center (ABC) have established a platform approach to Process Characterization that has been proven effective as it has been used to support the approval of several marketed products.
While there are some that choose to install a facility monitoring system just because regulatory guidance states one should be installed and used, many, given the choice, would choose not to.
The optically active pharmaceutical and its mirror image are referred to as enantiomers. While they might possess identical physical properties, their physiological properties can differ dramatically.
Contracting an in-country clinical depot helps bring costs and timelines under control.
Improper handling of residual solvents adds risk to quality and safety. Lack of experience and constrained capacity compound it.
With a broad range of level measuring principles available means that finding the ideal solution is easy. No principle is suited to all application areas. Therefore measuring systems must be selected that work reliably under the conditions of a particular application and, at the same time, meet the economic situations in the future. Endress + Hauser can support you from planning and commissioning through to the maintenance of your measuring point as well as assist you in automation, asset management and the visualization of process data.
With over 14,000 ft2 storage capacity and over 14 ICH and custom conditions, Nitto Avecia Pharma Services has the capability to help design stability studies tailored to product needs.
After almost 20 years, FDA issued new guidelines in 2018 for elemental impurities. Despite advanced notice, capacity and capabilities remain limited.