Please note:
- Provisional timetable, the actual schedule may vary depending on the Situation
- In certain cases participation may not be possible due to competitive reasons
Programme 17 May 2022
09.00 - 09.15 h Welcome/Introduction
09.15 - 10.15 h
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
10.15 - 10.30 h Break
10.30 - 11.30 h
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
11.30 - 12.00 h
Workshop: Fundamentals of Freeze Drying, Cycle Development and Scale-up
For effective freeze drying, each product requires a unique recipe (formulation); these formulations are initially developed on a laboratory or pilot-scale unit and it is imperative that formulation development takes both product characteristics and the limitations of pilot and production machines into account. This workshop will examine the procedures and consequences of process development and scale-up.
12.00 - 12.30 h
Q&A Session 1
12.30 - 13.30 h Break
13.30 - 14.30 h
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.)
14.30 - 14.40 h Break
14.40 - 15.15 h
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
15.15 - 16.00 h
Atmospheric Spray Freeze Drying
- Process understanding, monitoring & control
- Design of continuous lyophilization
16.00 - 16.15 h Break
16.15 - 16.45 h
Workshop Tour including visit of shelf manufacturing area, freeze dryer testing as well as simulation and system integration.
16.45 - 17.15 h
Q&A Session 2
Programme 18 May 2022
09.00 - 09.30 h
Hands On Demonstration of Production Scale Freeze Dryer Design and Functions
This workshop will provide each participant with an overview of a state-of-the-art production-scale freeze drying system, including system configuration.
09.30 - 10.15 h
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
10.15 - 10.30 h Break
10.30 - 11.15 h
Lyophilizer in Aseptic Production Lines - Challenges and Chances
- Loading and unloading of freeze dryers
- Lead times and campaigning
- Equipment characterizations
- FD cycles monitoring
- Vacuum and silicone oil leak tests
- Maintenance
11.15 - 11.45 h
Live Demonstration of Automated Loading and Unloading Systems
Demonstration of fully operative fixed and moveable load/unload system. Additionally, it will be possible to look at a system with special features, including online moisture control.
11.45 - 12.15 h
Q&A Session 3
12.15 - 13.15 h Break
13.15 - 14.00 h
Implications of the new Annex 1
- EU GMP Annex 1 – What´s new?
- GMP Issues in Inspections & Requirements for
- Sterile manufacturing of Lyo products
- Personnel (e.g. qualification, training, gowning, Monitoring)
- Sterile packaging materials
14.00 - 14.10 h Break
14.10 - 14.45 h
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
14.45 - 15.30 h
100% Inspection
- 100% quality monitoring for continuous production process improvement
- Different inspections:
- Container closure integrity (CCIT)
- Visual Inspection (defects / particles)
- AQL testing
15.30 - 15.45 h Break
15.45 - 16.15 h
Innovations in Freeze Drying Applications
This workshop will focus on processing Microwave Freeze Drying, as well as the use of environmentally friendly cooling systems and technologies for controlled nucleation and continuous freeze drying.
16.15 - 16.45 h
Q&A Session 4