Please note: In certain cases, participation may not be possible due to competitive reasons.
Fundamentals of Freeze Drying
Basic concepts and processes
- General advantages of freeze drying, product quality issues
- Classification and comparison of freeze drying processes
- Freeze drying in vials: Fundamentals of mass and heat transfer
- Role and importance of freezing
- Influence of process parameters, material properties, dryer design
- Process optimization, monitoring and control
- Freeze drying of frozen particles: Fundamentals of heat transfer, influence of mixing
Lyo-cycle Development and PAT-based Optimization
- Critical quality attributes and critical process parameters:
- assessment of critical process parameters through robustness testing to establish the process boundaries as the basis for the transfer from lab to commercial scale
- Freeze drying scale-up and validation:
- process qualification/validation in lyophilization strategies in relation to FDA/EMA modern process validation guidelines
- Process control strategies:
- hot and cold spot Determination to allow for process control by using a product temperature PAT device
Containment: Lyophilization of Highly Potent Compounds
Freeze dryer equipped with isolator
- An introduction to highly potent products
- Which are the critical limits and how are they evaluated?
- Correlation between critical limits and cleaning validation
- Determination of critical process steps
- Hardware solutions
- Examples
Lyophilization Technology - Design Requirements and Technical Solutions
- Main components of a lyo (chamber, condenser, refrigeration skid, vacuum skid, shelves, etc.)
- Purpose of these components
- Design criteria of these components (temperature homogeneity, cooling and heating capacity, sublimation capacity and gas flow, etc.)
Freeze Dryers in Aseptic Production Lines – Challenges and Chances
- Automatic Loading and Unloading of Freeze Dryers
- FD cycles: monitoring and challenges
- Turn-over times
- Lyoplus
- Steps towards higher sustainability
Aseptic Process Simulation (Media Fills)
- Media Fill Design
- Worst-case parameters for Media Fills
- Validation of lyophilization processes with Media Fills
- Requirements for Media Fills
- Trends with regards to Media Fills
Atmospheric Spray Freeze Drying
- Process understanding, monitoring & control
- Design of continuous lyophilization
Implications of the new Annex 1
- EU GMP Annex 1 – What´s new?
- GMP Issues in Inspections & Requirements for:
- Sterile manufacturing of Lyo products
- Sterile packaging materials
Qualification/Validation - to get the System tested
- Risk assessment in the context of qualification and validation
- QbD aspects for successful lyophilization projects
- Tests during qualification and validation
- IQ/OQ/PQ
- Concepts for reduced testing approach
- Definition of scope of supply (URS vs. supplier standard)
- Risk based life cycle approach in accordance with GAMP 5
LYO-CHECK: Next Level Automatic Visual Inspection & CCIT for Lyophilized Products
- Dedicated illumination patterns, wavelengths and advanced imaging techniques
- Particles detection dedicated optical setup
- LYO Handling & Inspection: how to avoid product dirt and damages
- How AQL sampling was integrated into the LYO and powder inspection process of a primary pharma manufacturer
- Applicable CCIT and Process Analytical Technologies via non-destructive methodologies
- AI Empowerment