Granulation - Process, Scale-Up, Trouble Shooting

Granulation - Process, Scale-Up, Trouble Shooting

Barcelona, Spain

Course No 15951


Costs

Non-ECA Members: EUR 1690,--
ECA Members: EUR 1490,--
EU GMP Inspectorates: EUR 845,--
APIC Members: EUR 1590,--

(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 Harald Stahl, GEA

Objectives

This course aims at providing you a deeper understanding of the different granulation techniques: Fluid Bed Granulation, High Shear Granulation and Roller Compaction.
This includes optimisation and trouble-shooting during:

  • The development phase
  • The scale-up and transfer phase
  • The routine and full-scale production

Background

Granulation is one of the most important manufacturing processes in the pharmaceutical and food industry. In the manufacture of pharmaceutical drugs, APIs and excipients are granulated before compression to tablets. This enhances flowability and adhesion of the powdery particles.

Different demands regarding the properties of granulates require different techniques. Today, fluid bed granulation, roller compaction, high shear granulation and spray drying are the most important techniques. Knowing how processing parameters influence product properties is essential for obtaining a product which meets the quality specification and requirements for further processing. In fact, most of the problems occurring in the compression step are caused by inappropriate granulation. A deeper understanding of the different granulation techniques is essential.
In addition to scale up aspects of the different granulation techniques this will be the main focus of this course.

  • Fluid Bed Granulation
  • High Shear Granulation
  • Dry Granulation
  • How to select the right technique
  • Hot to manage the different processes
  • Trouble shooting
Another highlight is the implementation of PAT in continuous granulation processes. This technology and most of all the process understanding help controlling varying process parameters and influences from raw materials. It also allows minimizing time and costs for scale up projects.

Target Group

This event is designated for all professionals from Development and Production, who are responsible for the development, the routine production or the scale-up and transfer of granulation processes.

Programme

Fundamentals - what is a good granulate
Even there is a recent trend to use often dry methods
in the production of solid dosage forms granulation remains for 2 reasons to be one of the most important unit operations. First it allows the use of simpler and cheaper excipients which is of paramount importance if large volume products have to be produced and second granulation can massively improve the compression behaviour of materials.

  • Overview of granulation methods
  • Theory of granulation
  • Benefits and limitations
Fundamentals – high shear granulation
High shear granulation is a popular granulation method. It is a robust granulation technique capable of handling most APIs, to produce granules of intermediate densities, between roller compacted and fluid bed processed granules. Operationally, control of the shear energy input for granulation is by changing the impeller speed. Design of the impeller and feed load have their effects on the granulation process. Thus, together with the impeller speed, the method and rate of liquid addition are also important critical process attributes to control the granulation process.

Fundamentals – fluid bed granulation
Fluid beds were first adopted by the pharmaceutical industry for drying granules after wet massing. Later, fluid bed granulation was introduced, to produce free flowing, spherical and porous granules direct from powders. The fluid bed granulator depends entirely on the fluidising air to lift and dry particles. The liquid addition rate and method of delivery system are important control determinants of the granulation rate. Various innovative changes have improved the fluid granulation processors. A discussion of the fluid bed technique and innovations to the fluid bed granulation processor will be provided.

Dry Granulation / Roller Compaction
Dry granulation is a common unit operation in solid dose manufacture. Small footprint, fast process development and scale-up, together with the option for continuous manufacturing are compelling arguments why roller compaction has become even more important for pharmaceutical industry nowadays.
Enhanced product and process understanding, following a Quality by Design approach, is key for a successful technology transfer to operations and smooth implementation in routine manufacture.

The session will cover following topics:
I
  • ntroduction and basic principles of roller compaction
  • Scale-up and process monitoring
  • Case studies
Even high shear granulation processes are already in use for many decades still scale up is often done by trial and error. In this session more scientific approaches are introduced.
  • Theory of high shear granulation
  • Identification and scale up of CPPs
  • The role of the end point- review of available technologies
  • The importance of suitable equipment and instrumentation
Scale-up fluid bed granulation
By their nature fluid bed processes can be much easier described by scientific models than high shear processes. However often these possibilities of science based scale up approaches have been ignored.
  • Theory of fluid bed processes
  • Identification and scale up of CPPs
  • The importance of suitable equipment and instrumentation
Scale Up of wet granulation processes: Practical aspects
Wet granulation processes, like fluid-bed and high shear granulation, have been widely applied for decades in pharmaceutical industry. Although multiple scale-up models and approaches are described in literature, mechanistic process understanding is still not yet mature. This session will focus on translation and relevance of different scale-up models into practice.
  • High shear and fluid-bed granulation: theoretical scale-up considerations
  • Case study: Scale-up of a high shear process
  • Case Study: Scale-up of a fluid-bed process
New Trends in Granulation: PAT, continuous manufacturing, etc.
Continuous processing is widely used in other industries such as food or chemicals. Over recent years also the pharmaceutical industry showed an increasing interest as well as authorities pushing for a wider use.
  • Why go continuous?
  • Examples of installations
  • Regulatory situation
  • Control strategy
Trouble-Shooting Workshop
In this interactive session, all the key elements of the preceding lectures are brought together. A systematic approach is presented and discussed with regards to the extent, trouble shooting measures have to be escalated: what can be done on the operator level, what can be done on the supervisor level, what must be done by development.

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