PDA Europe Pharmaceutical Freeze Drying Technology in Dublin - Kongress / Konferenz von PDA Europe gGmbH

1. REGULATORY UPDATES • Implications of Annex 1 Revision • Aseptic Process Validation • Aseptic Conditions • Container Closure Integrity Testing

2. MANUFACTURING TRENDS • Continuous Freeze Drying • Spray Drying • Controlled Nucleation • Low Temperature Drying • Live Biotherapeuticals • Fogging • Nanocapsules • Highly Potent Agents • Process Development for Generics, Proteins, Biologics and Vaccines

3. GREEN MANUFACTURING • Carbon Dioxide Footprint • Reduction of Energy Consumption • Optimized Cycle Times • Fluorinated Greenhouse Gases (F-Gases) Regulation

4. EQUIPMENT • Sensors • Wireless Probes • Loading/Unloading Systems • Robotics • Automation • Cleaning in Place • Sterilization in Place • Refrigeration System • Camera Systems • Silicon Oil Contamination

5. PRIMARY CONTAINERS • Headspace Analysis • Stoppers • Capping • Container Closure Integrity • Plastic Polymer Containers • Dual Chamber Containers • Vial Breakage

6. QUALITY ASPECTS • Process Analytical Technology • Control Strategy • Quality by Design • Continuous Process Verification • Validation • Critical Quality Attributes • Matrixing Strategies • Bracketing Approach

7. PROCESS CONTROL • Pressure Monitoring • Temperature Measurement • Heat Flux Measurement • Headspace Moisture Measurement • Impedance Spectroscopy • Mass Spectrometry • Thermal Mapping • Digitalization • Leak Rates • Stability • Cake Appearance • Freeze Drying Microscope