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Parenteral Drug Association Connecting People, Science and Regulation ®

Journal TOC

Feb 25, 2019

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 “

Conversations

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