Former Head of the Pharmaceutical Inspection Dpt. AFSSAPS
All times mentioned are CEST.
Objectives
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 intensive 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. An introduction to the different GMP requirements for manufacturing solid dosage forms worldwide is therefore also subject of this course.
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, high-shear or dry granulation are the most commonly used processes. An important part of this course 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. A separate block of this seminar is dedicated to the issue of Trouble Shooting. Please bring your questions concerning manufacturing problems with you or send them in beforehand.
These challenges are met by new excipients, new control algorithms for tablet presses, laminations as well as special punches and dies. Having the presses run slower should be a last resort after all other options have failed.
Further topics of this training are the tableting of highly active materials, the implementation of recent validation requirements based on the example of tablet manufacturing as well as continuous manufacturing.
Target Group
This intensive course is designated for all professionals from Pharmaceutical Development, Production and QA/Regulatory Affairs, who are responsible for the development, the routine production or the Scale-Up and transfer of tableting processes.
Technical Requirements
We use Webex for our live online training courses and webinars. At www.gmp-compliance.org/training/online-training-technical-information you will find all the information you need to participate in our events and you can check if your system meets the necessary requirements to participate. If the installation of browser extensions is not possible due to your rights in the IT system, please contact your IT department. Webex is a Standard nowadays and the necessary installation is fast and easy.
Fundamentals of granulation – 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
Excipients for granulation and their impact on product properties
Fundamentals of Fluidbed-Granulation
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
Scale-Up of Fluidbed Granulation
Fundamentals of Fluidbed Granulation (process & technology)
Which process parameter influences which product quality attribute
How to scale-up?
Consequences for the quality critical attributes
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
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
Fundamentals of Roller Compaction / Dry Granulation Dry granulation is gaining more and popularity in the pharmaceutical industry as it may offer advantages like fast development and Scale-Up, usability in continuous manufacturing operations and improved process control
Design aspects of a modern roller compactor
Impact of process parameters like compaction force, gap, roll speed, roll surface, roll width and side seal system on ribbon properties
Principles of densification: solid fraction as critical material attribute
Scale-Up
Wrap-Up: Overview and comparison of the different granulation techniques - An Outlook
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
Factors for a 6-sigma granulation process
Which optimisation is possible by using continuous Granulation
Control of continuous processes
Tableting: Process, Equipment and Formulation
Physical fundamental of powder adhesion
Compressibility and compactibility of different materials
How to quantify these properties?
How to handle materials with unfavourable compression properties?
Parts of tablet presses: their function and their impact on product properties
Comparison of the different control philosophies
Measurement of the deformation behaviour by compression analysers
Overview and characterisation of the most important excipients used for compression
Scale-Up of tableting processes
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
Case studies
Global requirements for OSD operations
OSD Quality Attributes: from homogeneity to dissolution
Pharmacopoeias and OSD: main monographs
Requirements from the main guides: US, EU/PICS & WHO
Requirements from special chapters: US, UK and France
Handling of highly potent materials – Containment for tableting processes
How much containment is really needed
Identification of critical operations (with regards to exposition)
Comparison of different containment concepts
Examples of existing equipment
Validation of a tableting process
Main Pharmacopoeial descriptions for tablets
What are the main validation requirements
Tablets Quality Attributes and Tableting Critical Parameters
Establishing a protocol not forgetting intermediate steps
Running the process not neglecting secondary operations
Writing a clear and trustful Report
Following tablets stability issues
Conclusion
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
This course is part of the GMP Certification Programme "ECA Certified Technical Operations Manager" Learn more
Testimonials
Seminar Programme as PDF