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 “