Category: CESPE Academy

COURSE OVERVIEW

This course gives an introduction on the (pharmaceutical) relevance of (raw) material characterization. An overview is given about the relevant characterization methods on the market, their applicability and how the material properties can be used to describe the processability.
This 1-day course consists out of a theoretical (interactive) and hands-on part.

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MODULE 1: BASIC COURSE

Theoretical

The trainee will get an in-depth explanation about the different characterization methods, their (pharmaceutical) relevance and what you can do with the generated data.
Some of the key material characteristics described are:

Flow/cohesion
&
Particle size and shape
&
Density and porosity
&
Electrostatic charge
&
Melting point and crystal structure
&
Viscosity

Practical

Hands-on sessions will allow the trainee to get a feel with what it takes to characterize a material.
The extensive array of characterization equipments, available at CESPE, will be made available to visualize the difference between highly divergent powders.
Some of the equipment that will be used are:

FT4 Powder Rheometer
&
Schulze Ring Shear Tester
&
Granutools^TM equipment
&
Malvern Laser diffractors
&
DVS and DSC equipment

Upon request, a powder of interest could be tested on the available equipment!
For more information, please contact Bram.Bekaert@UGent.be .

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COURSE PROGRAM

A detailed overview of the course can be found in the following document.

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If you are interested in following this course, please take a look at planned sessions.
For further questions or requests, please use the contact form.

COURSE OVERVIEW

This course focusses on giving a thorough introduction about the implementation of PAT tools in the (bio)pharmaceutical industry.
This course is given in an interactive manner (both theoretical and hands-on) and can be divided into three separate modules:

Module 1: Basic course: Introduction to PAT implementation (1-day module)
&
Module 2: Advanced course: Data-analysis and modelling (Python) (2-day module)
&
Module 3: Specialized courses (1/2-day module)

Requirements
Basic understanding of spectroscopy and (bio)pharmaceutical processes
&
Basic understanding of coding and programming (python)

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MODULE 1: BASIC COURSE

Theoretical

The trainee will get an in-depth explanation about the common (non-)spectroscopic PAT sensors and will learn how, when and where these tools can provide a benefit.

Spectroscopic PAT tools
&
Non-spectroscopic PAT tools
&
Hyperspectral imaging
&
PAT in R&D
&
Regulatory aspects
&
Multivariate data-analysis

Practical

The trainee will get the chance to see how PAT tools can be implemented and how this translates in a practical approach to acquire relevant process information.
Some of the tools that will be demonstrated are:

NIR
&
Raman
&
Other PAT devices

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MODULE 2: ADVANCED COURSE

Theoretical

This module looks at the steps that follow after a successful implementation of the PAT tools. The trainee will learn on how to analyze and use the acquired data in multivariate models.

Introduction to Python
&
Data preparation
&
Linear and non-linear modelling
&
Multivariate data-analysis

Practical

During the course, the trainee will use placebo data sets to learn how to analyze and use the data.

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MODULE 3: SPECIALIZED COURSES

In this module, the goal is to highlight specific examples, using real spectroscopic data in the form of use-cases.

Topics

Model predictive control
&
Unit operation-specific spectroscopic data-analysis
&
Bring your data to course day*

*The trainee has the option to bring his/her own data to the course. Together with the tutor they can go through the data and learn how to proceed.

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COURSE PROGRAM

A detailed overview of the different modules can be found in the following document.

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If you are interested in following this course, please take a look at planned sessions.
For further questions or requests, please use the contact form.

COURSE OVERVIEW

Lyophilization 101 focusses on giving a thorough introduction about pharmaceutical freeze-drying in an interactive manner (both theoretical and hands-on).
Throughout this 2-day course, the trainee gets to understand the basic and fundamental aspects from start untill finished product.

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MODULE 1: BASIC COURSE

Theoretical – day 1

During the first day of the course, the trainee will get an in-depth explanation about the basic freeze-drying principles such as:

Freeze-drying equipment
&
Heat and mass transfer mechanisms
&
(Dis)advantages
&
Modelling of the freeze-drying cycle
&
Optimization of the process

Practical – day 1

Hands-on sessions will allow the trainee to get a feel with the freeze-drying process.
The hands-on session will cover:

Tour of the CESPE freeze-drying lab
&
Sample preparation and characterization
&
Starting your first run

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Theoretical – day 2

During the second day, the focus will be put on PAT implementation and post-run analytics, allowing the trainee to deep-dive in the generated data.

Process analytical technologies (PAT)
&
Pre- and Post-run analytics
&
The future of freeze-drying: Continuous vs. Batch

Practical – day 2

Hands-on sessions during day 2 will mainly focus on the analysis of the performed run of practical day 1.
The hands-on session will cover:

Evaluation of the freeze-drying run
&
Water content determination
&
DSC
&
Sneak-peek at a continuous freeze-dryer

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COURSE PROGRAM

A detailed overview of the program can be found in the following document.

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If you are interested in following this course, please take a look at planned sessions.
For further questions or requests, please use the contact form.

COURSE OVERVIEW

Twin screw granulation 101 focusses on giving a thorough introduction about the granulation process in an interactive manner (both theoretical and hands-on).
This course can be divided into three separate modules:

Module 1: Basic course: Introduction to twin screw wet granulation (1-day module)
&
Module 2: Basic course: Introduction to twin screw hot-melt granulation (1/2-day module)
&
Module 3: Specialized courses (1/2-day module)

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MODULE 1: WET GRANULATION

Theoretical

The trainee will get an in-depth explanation about the basic twin screw wet granulation aspects such as:

Equipment overview
&
Principles of wet granulation
&
Batch vs continuous manufacturing
&
Process and formulation parameters
&
Granule characterization

Practical

The in-house ConsiGma^TM -25 line will be used to demonstrate the twin screw wet granulation process. Afterwards, the produced granules will be tested using the available granule characterization methods.
The hands-on session consists out of:

ConsiGma^TM-25 demonstration with placebo
&
Introduction to granule characterization methods

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MODULE 2: HOT-MELT GRANULATION

Theoretical

The trainee will get an in-depth explanation about the basic twin screw hot-melt granulation aspects such as:

Equipment overview
&
Fundamentals of hot-melt granulation
&
Equipment configurations and settings
&
Pitfalls
&
Granule characterization*

*Will be skipped if module 1 was followed as well.

Practical

The trainee will be able to follow and help during placebo trials using a twin screw hot-melt granulator. The influence of process and formulation parameters will be demonstrated.

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MODULE 3: SPECIALIZED COURSES

In this module, the goal is to highlight specific aspects of the granulation process through different use-cases. Each use-case allows the trainee to get an in-depth comprehension of a specific part of the process.

Topics

Wet granulation: Modified release formulations
&
Wet granulation: Impact of dry or wet addition

The trainee has the option to take up all of the provided topics, covering a half day course, or select a sub-set of these topics.

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COURSE PROGRAM

A detailed overview of the different modules can be found in the following document.

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If you are interested in following this course, please take a look at the planned sessions.
For further questions or requests, please use the contact form.

COURSE OVERVIEW

Feeding 101 focusses on giving a thorough introduction about the feeding process in an interactive manner (both theoretical and hands-on).
This course is divided into two separate modules:

Module 1: Basic course: Introduction to feeding (1-day module)
&
Module 2: Specialized courses (1/2-day module)

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MODULE 1: BASIC COURSE

Theoretical

The trainee will get an in-depth explanation about the basic feeding aspects such as:

Types of feeding equipment
&
Feeder accessories and their function
&
Types of feeder trials
&
Feeder data acquisition and analysis

Practical

During the hands-on sessions, the trainee will learn on how to install, operate and dismantel a loss-in-weight feeder.
The feeder demonstrations will be performed using two divergent materials.

Upon request, a powder of interest could be tested on the available equipment!
For more information, please contact Bram.Bekaert@UGent.be .

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MODULE 2: SPECIALIZED COURSES

In this module, the goal is to highlight specific aspects of the feeding process through different use-cases. Each use-case allows the trainee to get an in-depth comprehension of a specific part of the process.

Topics

Surrogate approach for feeding
&
Impact of glidant addition
&
How specific configurations and settings can impact the feeding performance

The trainee has the option to take up all of the provided topics, covering a full day course, or select a sub-set of these topics.

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COURSE PROGRAM

A detailed overview of the different modules can be found in the following document.

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If you are interested in following this course, please take a look at planned sessions.
For further questions or requests, please use the contact form.