Lyophilization Technology: Product, Process and Systems
We are pleased to welcome in our Allentown facilities our partners in BioPharma for the Lyophilization Technology: Product, Process and Systems training course on March 10th to 12th.
The course provides an opportunity to explore a wide range of elements in the lyophilization process. From characterization of products to cycle development and scale up, the training course covers the science and engineering of lyophilization. In addition, the programme will also include SMS innovative instruments, such as the DVS and how it can assist in product analysis.
• Welcome & Course Introduction
• Introduction to Lyophilization – process, features and equipment
• Product Freezing – conditions to influence ice crystals and solutes, Controlled Nucleation
• Refrigeration and Thermal Transfer Systems -design elements of refrigeration systems in lyophilizers
• Primary and Secondary Drying – principles and practical aspects of primary drying (sublimation) and secondary drying (desorption)
• Stoppering Systems – functional requirements of shelf stoppering systems, alternative designs
• Formulation for Lyophilization – formulation design issues and strategies for lyophilized products
• Process Condensers (Vapour Trap) – protecting the product and the vacuum system from damage
• Formulation Characterization – methods applied to formulations prior to lyophilization
• Vacuum Systems – pumps used to achieve the desired pressure, types of pressure gauge employed, methods for leak detection
• Cycle Development & Scale-Up – conditions for loading lyophilizer, freezing and drying
• Process Monitoring – temperature measurement and process analytical technology (PAT)
• Alternative Approaches to Cycle Development – the use of software-based cycle development programs, application of a Quality by Design (QbD)
• Workshop Session – evaluating lyophile appearance
• Containers, Closure and Barrier Technologies – container designs and materials, types of closure and containment options
• Product Analysis (Part 1) – moisture content and long term stability, methods of moisture thermal analysis
• Cleaning and sterilization of Freeze-Dryers – manual cleaning and automated ‘clean-in-place’ (CIP) and ‘steam-in-place’ (SIP) systems
• Product Analysis (Part 2) – the appearance, structure and mechanical properties of lyophilized products, modern techniques such as DVS
• Maintenance and Troubleshooting – pros and cons of maintenance strategies, common problems
• Product Analysis (Part3) – modern techniques such as DVS employed to quantify specific aspects of the lyophilized products
• Workshop Session – multidisciplinary problemsolving group exercise, designing your own lyophilizer
Who is this course right for?
Diagnostics e.g. medical
Engineers/ Technical Support
Or visit the training course website.