Lyophilization Technology: Product, Process and Systems

April 09-11/2019
PENNSYLVANIA, USA

BioPharma Course

Course Overview

Biopharma is pleased to announce our collaboration with SMS Labs to provide upgraded facilities for our training course delegates, future events and local technical support. This 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, we cover the science and engineering of lyophilization. In addition, the programme will include SMS innovative instruments, such as their DVS and how it can assist in product analysis.

Day One

Welcome & Course Introduction
• Introduction to Lyophilization – process, features and equipment
• Break
• Product Freezing – conditions to influence ice crystals and solutes, Controlled Nucleation
• Refrigeration and Thermal Transfer Systems -design elements of refrigeration systems in lyophilizers
• Lunch
• 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
• Break
• Formulation for Lyophilization – formulation design issues and strategies for lyophilized products
• Process Condensers (Vapour Trap) – protecting the product and the vacuum system from damage

Day Two

• 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
• Break
• Cycle Development & Scale-Up – conditions for loading lyophilizer, freezing and drying
• Lunch
• 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)
• Break
• Workshop Session – evaluating lyophile appearance

Day Three

• 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
• Break
• 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
• Lunch
• 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

To receive the detailed course agenda please contact us on the following address:
[email protected] or [email protected]rementsystems.com

Or visit the training course website.