Whitepapers

Jun 22, 2018
Sponsored Content
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, the 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.
Jun 21, 2018
Sponsored Content
Optimal PAT for wet granulation monitoring has significant potential to improve the efficiency of tableting operations. This whitepaper showcases the value of dynamic powder testing and a complementary new in-line PAT for real-time granulation monitoring. Together these technologies deliver efficient endpoint detection and continuous process measurement.
May 24, 2018
Sponsored Content
Upgrading to modern single-use powder handling in your process gets your product to market without wasted on complicated weigh and dispense steps, cleaning validations, or worries about powder in the air and in the room.
May 24, 2018
Sponsored Content
Informative packaging serialization requirements & deadlines with keys to combating worldwide drug counterfeiting. Topics include supply chain serialization techniques like Microscopic RFID Tags, Security Labels, Invisible Inks, and Track-and-Trace Technologies.
May 24, 2018
Sponsored Content
By EtQ
This white paper explores the three most critical functions for automation in a Life Science organization, so you can smoothly transition to an effective quality management process while increasing effectiveness and efficiency.
May 22, 2018
Sponsored Content
Understand the difference between cleaning and disinfection procedures in controlled environments. How to optimize your TruCLEAN Mopping System for maximum contamination control.
May 22, 2018
Sponsored Content
Responding to severe regulatory criticism? Need some essential guidance? This white paper by Martin Lush includes step-by-step guidance on how to write to regulatory agencies when things go wrong.
May 21, 2018
Sponsored Content
Watch this video to learn five ways quality teams can lower costs and increase profitability. Total cost of quality is a term used to determine the resources needed to prevent poor quality. Generally, three quarters of these cost come from outside of the quality department. To increase company-wide operational efficiency, quality teams must implement systems and processes to communicate and collaborate with internal and external partners.
May 21, 2018
Sponsored Content
Diverted and falsified drug products create safety risks in the supply chain. On-dose authentication methods can assign special code libraries to groups, lots, or manufacturing segments of product and can complement serialization.
May 21, 2018
Sponsored Content
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).
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