Granulation & Tableting

Granulation & Tableting

Prague, Czech Republic

Course No 17179


Costs

Non ECA Member: EUR 1990,--
ECA-Member: EUR 1790,--
EU/GMP Inspectorates: EUR 995,--
APIC Member Discount: EUR 1890,--

(All prices excl. VAT)

If you have any questions, please contact us:
Tel.: +49 (0)6221 / 84 44 0 E-Mail: info@gmp-compliance.org

Speakers

Dr Michael Braun, Boehringer Ingelheim Pharma
Dr Jean-Denis Mallet, Former Head of the French Pharmaceutical Inspection Dpt. AFSSAPS
Dr Harald Stahl, GEA
Prof Dr Karl G. Wagner, University of Bonn

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.

Trouble-Shooting: Discussion

Final part of the course is an open discussion where you will find help for your special cases. Bring your questions/problems/troubles with you to the course or send them beforehand so that the speakers can prepare themselves for finding answers. Send your cases to eicher@concept-heidelberg.de, subject: “Trouble-Shooting Tableting”

Programme

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 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

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 and Scale-Up

  •  Plant geometry and design
  •  Process parameters (degree of filling, torque-speed, humidity, time)
  •  Methods of drying
  •  Special Case: Single-Pot-Granulation
  • Scale-Up: influence of  impeller speed, dosing speed

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

Fundamentals of tableting/compression and tablet-presses
 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
 Special cases: effervescent tablets
 Comparison of the different control philosophies

Excipients for tableting: their selection corresponding to their mechanical compatibility
 Fundamentals of deformation and cohesion of tablets
 Measurement of the deformation behaviour by compression analysers
 Overview and characterisation of the most important excipients used for compression
 Practical task: selection of appropriate API and excipient combinations
 Case Studies

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

Validation of a tabletting process

  •  Main Pharmacopoeial descriptions for tablets
  •  What are the main validation requirements
  •  Tablets Quality Attributes and Tabletting 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

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

Continuous manufacturing

  •  Factors for a 6-sigma granulation process
  •  Which optimisation is possible by using continuous granulation
  •  Control of continuous processes
  •  The Consigma Systems as one example for continuous manufacturing equipment
  •  PAT

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

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