Thomas Beutler, GEA, Germany
Florence Buscke, Schott, Germany
Anthony Cannon, Samsung Biologics, Korea
Maik Guttzeit, GEA, Germany
Kristien Janssen, Pfizer, Belgium
Benjamin Kammerich, GEA, Germany
Olaf Plaßmann, GEA, Germany
Dr Harald Stahl, GEA, Germany
Prof Evangelos Tsotsas, University of Magdeburg, Germany
Dr Andrea Weiland-Waibel, Explicat, Germany
Take advantage of the opportunity to focus on freeze drying technologies and processes and get a first hand demonstration of solutions for diverse requirements. Further, benefit from the workshop where you can get a hands-on experience in freeze drying yourself. In small groups, you will learn how the freeze drying output is affected by different equipment, parameter changes, solvents etc.
Lyophilization (or freeze drying) is one of the most exciting technologies in the pharmaceutical industry, although it is a very old process for the preservation of unstable materials. Trends are growing towards using non-aqueous systems.
Additionally, Process Analytical Technology (PAT) systems for in-line process monitoring are used to control and determine critical processing parameters.
Modern development following ICH Q8, Q9 and Q10 is based on the objective to design a lyophilization cycle applying a systematic and scientific approach instead of trial and error. Sufficient process understanding is essential to achieve a robust production process and efficient handling of post-approval changes (life cycle management) of a freeze drying process.
There is an increasing trend in aseptically produced lyophilized products, including peptides and proteins. Owing to the nature of these biological products, the lyo-cycle is more complicated and, in most cases, even longer than for other medicinal products.
The utility of lyophilization goes far beyond the vial. Principles of low temperature, low pressure can be applied to stabilize substances ranging from high potent APIs, novel medical devices, biologics and nanomaterials, freeze drying offers multiple opportunities.
This conference addresses specialists and executives working in the fields of pharmaceutical manufacture, research and development and quality control, as well as engineers, project/facility engineers, especially those involved in the implementation of new monitoring methods for controlled nucleation, risk-based scale-up models and process technology for freeze drying processes. The conference is also of interest for participants working in the areas of container development and manufacturing process/packaging.
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
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
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.)
Lyophilizer in aseptic production lines - challenges and opportunities
Loading and unloading of freeze dryers
Control of sterility
Vacuum and silicone oil leak tests
Focus on trends in packaging systems
Considerations in container selection: Thermal shock, vial construction
Hydrophobic Coating to improve lyophilization?
How to organize a GMP-compliant lyophilization project
Effective customer/supplier relation
Definition of scope of supply (URS vs. supplier standard)
Managing project organization and set up of controls
Risk based life cycle approach in accordance with GAMP 5
Software design, testing and documentation in lyophilization projects
What are the basics for the development of software applications in lyophilization projects?
Handling of standardized software modules and the structured process of adjustments in a master application
The continuous documentation process depending on internal and external design and approval requirements
Test procedures for internal qualification process
Change management for validated software applications in lyophilization projects
Qualification/validation and the use of QbD for freeze drying
Risk assessment in the context of qualification and validation
QbD aspects for successful lyophilization projects
Tests during qualification and validation
Concepts for reduced testing approach
Retrofit – effective concepts for refurbishment of existing lyophilizers
Assessment of current situation. First, but most important step to success
Different retrofit concepts and solutions
Limitations for time and cost effective retrofits
Controlled nucleation as part of retrofit
Advantages (and disadvantages?) of controlled nucleation
Workshops at GEA on Thursday, 12 May 2016
On the third conference day, you will have the opportunity to take part in several parallel workshops. For that purpose, several lyophilizers will be available at GEA. Experienced GEA experts will lead you in small groups, providing an intensive experience and directly applicable know-how.
Target group of the Course:
Process Engineers, Pharmaceutical Technologists, Pharmaceutical Formulation Scientists, Application Chemists, Drug Development Engineers, Particle Design Engineers.
Fundamentals and operation of freeze dryers, details on system configuration and basic controls
Cycle development and scale-up to pilot/commercial-scale freeze dryer
Fundamentals and operation of automated loading and unloading systems
Software development and simulation
New innovations in freeze drying applications, like silicone oil detection with mass spectroscopy, controlled nucleation, vial track-and-trace (for experts)
A shuttle bus will bring you to Cologne Central Station at approximately 16.15 h.
From Cologne Central Station, frequent airport connections are available.
It is highly recommended that you bring your own safety shoes, if available.