Build your pharma development and manufacturing knowledge base with the latest whitepapers, application notes, posters, and other educational resources from bio/pharma industry suppliers.

Analysis Using Counter-Rotating Twin Screw Extruder

Brian Machado, Abbe Haser, Feng Haight, Charlie Martin, Augie Zhang; Leistritz Extrusion

Various extrusion operating conditions and formulations were used to enhance the solubility and recovery of Meloxicam (MLX) in copovidone to near 100% on a counter-rotating twin screw extruder (TSE).

Mitigating Hidden Risks: Extractables and Leachables Expert Detection of Impurities Can Improve Product Safety and Regulatory Success

Christopher Wittum, scientist II, Analytical Research and Development; Avista Pharma

During the drug development process, it is important to identify any risks of product adulteration that could present a risk of toxicity, or affect stability or efficacy. It is widely accepted that drug makers must eliminate impurities in the drug product itself, but more recently, regulatory agencies have scrutinized the impact of impurities that may arise from the packaging of materials. In 1999, following extensive studies on the propellants used in metered dose inhalers, FDA mandated that pharmaceutical manufacturers demonstrate the safety of materials used in production systems, container-closure systems, and drug-delivery devices. To comply with these standards, testing of extractables and leachables (E&L) is routinely performed to evaluate the potential for various chemicals to migrate from containers into drug products and biologics.

Drive Operational Certainty in the Life-Sciences Industry

Emerson

To meet production goals, you need to ensure that products are delivered to specification and that documentation and compliance requirements are met. Reducing excessive work in process, eliminating the inefficient use of resources, and better management of your operations will lead to increased profitability for your organization. Emerson’s Syncade manufacturing execution system (MES) helps you gain visibility and improve manufacturing processes to meet production goals.

Peak Performance: How Quality Can Drive Company-Wide Operational Efficiency

Sparta Systems, Inc.

In this paper, the authors explore why quality teams must expand their focus beyond compliance, how they can impact operational efficiency and economic performance across multiple departments, and the processes and systems needed to achieve their goals.