How can continuous environmental monitoring reduce interventions during aseptic manufacturing? Find out in the latest issue of the PDA Journal of Pharmaceutical Science and Technology.

Research

• Jakob Buecheler, et al., “Residual Seal Force (RSF) Testing: A Suitable Method for Seal Quality Determination also for High Potent Parenterals”
• Jeffrey Weber, et al., “Continuous Microbiological Environmental Monitoring for Process Understanding and Reduced Interventions in Aseptic Manufacturing“
• Dennis Jenke, “Application of Arrhenius Kinetics to Acceleration of Controlled Extraction Studies “

Technology/Application

• Søren Dahl, et al., “Container Closure Integrity Testing – Method Development for Freeze Dryed Products Using laser based Headspace Oxygen Analysi“

Commentary

• Dennis Jenke, “How One Might Experimentally Determine if Container Closure Systems and their Components and Materials of Construction Contribute Elemental Impurities to Packaged Pharmaceutical Drug Products“
• Paul Barone, et al., “Biopharmaceutical Industry Approaches to Facility Segregation for Viral Safety: An Effort from the Consortium on Adventitious Agent Contamination in Biomanufacturing“

Review

• Joseph N. Tanyous, “Cleaning Validation: Complete guide for health-based approach in chemical cross contamination risk assessment “