A thorough root cause analysis often reveals that compression issues such as capping, sticking and weight variations are related to the upstream granulating process. The objective of this training is therefore to provide a deeper insight into functional relationships between granulation and tabletting in order to avoid such problems from the very beginning. The training also conveys a deeper understanding for tableting and granulating processes, including Scale-Up, which helps in avoiding problems or solving them in practice. This also complies with the GMP principle of understanding and controlling the critical parameters of manufacturing processes.
Background
Granulation and tableting are considered the most commonly used manufacturing processes in the pharmaceutical industry. Of course, a direct compression process is most preferred; in practice, however, an upstream granulation is usually required to obtain a favourable particle size distribution, flowability and compactibility. Different requirements for granulates call for different procedures or technologies. Nowadays, fluid bed and high-shear granulation are the most commonly used processes. An important part of this training is therefore to introduce the different granulation methods, their basic principles and Scale-Up approaches. A deeper insight into process parameters and their influence on product properties is also part of the programme. The holistic approach to granulation and tableting therefore aims at avoiding issues from the very beginning and to overcome problems at an industrial scale through in-depth process insights. Having the presses run slower should be a last resort after all other options have failed. Therefore Trouble Shooting and solving tableting issues in case of lamination, sticking or weight variances is also part of this training.
Target Group
This video training is designated for professionals from Pharmaceutical Development, Production and QA/Regulatory Affairs, who are involved in the development, the routine production or the Scale-Up and transfer of tableting processes.
Technical Requirements
For our webinars, we use Cisco WebEx, one of the leading suppliers of online meetings. At http://www.webex.com/test-meeting.html you can check if your system meets the necessary requirements for the participation at a WebEx meeting and at the same time install the necessary plug-in. Please just enter your name and email address for the test. If the installation is not possible because of your rights for the computer system, please contact your IT department. WebEx is a standard nowadays and the necessary installation is fast and easy.
Programme
09.00 – 09.45 h Introduction – What is a good Granulate?
Reasons for granulation
Overview of the different granulation processes
Impact of the single processes on the granulate properties
Understanding the mechanisms of agglomeration
Characterisation of granulates
09.45 – 10.40 h High Shear Granulation: Fundamentals
Plant geometry and design
Process parameters (degree of filling, impeller Speed, liquid saturation, process time)
Methods of drying
Special Case: Single-Pot-Granulation
10.40 – 11.00 h Break
11.00 – 11.35 h High Shear Granulation: Scale-Up
Influence of impeller speed, liquid addition rate and wet massing time
Review of end point detection methods
Scale up trouble shooting
11.35 – 12.20 h Fluidbed-Granulation: Fundamentals
Design aspects and working principle of a modern fluidbed-dryer
Basic principle and advantages of fluidbed-granulation
Impact of process parameters on product properties
Process insights: how to run, control and design the process
12.20 – 12.45 h Questions & Answers
12.45 – 13.30 h Break
13.30 – 14.30 h Fluidbed Granulation: Scale-Up
Fundamentals of Fluidbed Granulation (process & technology)
Which process parameter influences which product quality Attribute
How to scale-up?
Consequences for the quality critical attributes
14.30 – 14.45 h Break
14.45 – 15.25 h Wrap-Up: Overview and Comparison of the different Granulation Techniques – How to choose the right one?
Which technique for which kind of product: viewpoint of development
Which technique for which product portfolio: viewpoint of production
Comparison of direct and indirect cost: viewpoint of Management
Continuous manufacturing- pros and cons
Continuous manufacturing- real world examples
15.25 – 15.55 h Fundamentals and Scale-Up of Tableting
Physical fundamental of powder adhesion
Excipients and their selection corresponding to their mechanical compatibility
Critical Process Parameters
Parts of tablet presses: their function and their impact on product properties
Comparison of the different control philosophies
Compression issues during Scale-Up and Transfer Quality by Design helps to overcome Scale-Up issues
Scale-Up and optimisation of compression processes
Constant dwell time as Scale-Up approach: theory and practice
15.55 – 16.10 h Break
16.10 – 17.00 h Trouble Shooting in Tableting Processes: Sticking, Capping & Lamination
Reasons for tableting problems
Possible changes in upstream processes
How to improve compression properties
Tips and tricks for production: possible changes within the existing equipment and registration environment
17.00 – 17. 30 h Questions & Answers
This course is part of the GMP Certification Programme "ECA Certified Technical Operations Manager" Learn more
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