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CESPE Academy Courses

Process Control and Optimization

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COURSE OVERVIEW

This course addresses the question of how we can keep pharmaceutical processes in optimal manufacturing conditions while ensuring versatility, resilience and quality of end product. Pharmaceutical control systems that are sustainable and balance the ecological footprint with ensuring access to high quality products and maintaining profitable supply chains. This question is part of the larger (international) challenge to ensure sustainable demand and production patterns, by improving environmental and societal sustainability and increasing the circularity in pharmaceutical production systems. This course is divided into two separate modules:

Module 1: Process identification: (1/2-day – morning)
&
Module 2: PID-based process control (1/2-day – afternoon)

MODULE 1: Process Identification

Theoretical

This course will provide interactive learning and real-world application, so you can directly apply what you’re learning to your own context

The following will be addressed:

Fundamentals of process identification
&
Understanding process dynamics
&
Identification at operator level (e.g. first order plus dead time approximation model)
&
Systems identification from relay experiments (PRBS identification)

Target audience

People with no experience/expertise in the topic
&
People that want a refreshment on the basic principles


MODULE 2: PID-based process control

This course will provide interactive learning and real-world application, so you can directly apply what you’re learning to your own context

The following will be addressed:

PID based control for process optimization
&
Auto-tuning methods for PID design
&
Frequency response design for PID design (FRTool)

The session will end with an overview of advanced process control methodologies (e.g. model predictive control, event-based control, etc.) able to ensure plant-wide optimization.

Target audience

People with no experience/expertise in the topic
&
People that want a refreshment on the basic principles


COURSE PROGRAM

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

Process-Control and-OptimizationDownload

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.

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CESPE Academy Courses

Material characterization

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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.

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
&
GranutoolsTM 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 Sarah.Costers@UGent.be .

COURSE PROGRAM

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

Material-characterization-1Download

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.

Categories
CESPE Academy Courses

Process Analytical Technologies

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COURSE OVERVIEW

This course focusses on giving a basic 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 two separate modules:

Module 1: Basic course: Introduction to PAT (1-day module)
&
Module 2: Basic data-analysis and modeling (1.5-day module)

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

MODULE 1: BASIC COURSE: INTRODUCTION TO PAT

Theoretical

The trainee will get a general introduction to PAT and the common (non-)spectroscopic sensors, learning how, when and where these tools can provide a benefit.

Spectroscopic sensors
&
Non-spectroscopic sensors (Univariate/Multivariate)
&
Hyperspectral imaging
&
PAT in R&D/Process Validation/QbD
&
Regulatory aspects
&
Multivariate data-analysis

Practical

The trainee will get the chance to see how PAT tools can be used/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
&
FLIR

Target audience

People with no experience/expertise in the topic
&
People that want a refreshment on the basic principles

MODULE 2: BASIC DATA-ANALYSIS AND MODELING

Theory through practice

Using spectroscopic data, the teacher will go through different aspects of PAT and model development together with the attendee.

General introduction to Python
&
Data preparation and exploration
&
Introduction to modeling
&
Process control based on PAT

Target audience

People with no experience/expertise in the topic
&
People that want a refreshment on the basic principles

COURSE PROGRAM

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

PATDownload

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.

Categories
CESPE Academy Courses

Tableting 101

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COURSE OVERVIEW

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

Module 1: Basic course: Introduction to the tableting process (1/2-day module)
&
Module 2: Deeper dive into specific tableting aspects (1/2-day module)

MODULE 1: BASIC INTRODUCTION TO THE TABLETING PROCESS

Theoretical

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

Basic fundamentals
&
Tableting equipment
&
Tablet formulation
&
Tableting process
&
Compaction mechanisms and models

Theory through practice

Theory about two divergent tableting systems will be given through hands-on sessions: setting up the equipment; explanation of all parts; tablet production; tablet quality determination.
Materials/blends will be processed throughout the session on the following equipment:


Compaction simulator
&
Rotary tablet press (MODULTM P)

Target audience

People with no experience/expertise in the topic
&
People that want a refreshment on the basic principles

MODULE 2: DEEPER DIVE INTO SPECIFIC TABLETING ASPECTS

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

Topics

Lubrication (internal/external)
&
Sticking
&
Die filling
&
Compaction models

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.

Target audience

People that understand the basic principles of the process and want to have a more in-depth knowledge on specific aspects.

COURSE PROGRAM

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

Tableting_101Download

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.

Categories
CESPE Academy Courses

Lyophilization 101

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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.

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

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

COURSE PROGRAM

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

Lyophilization-101Download

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.

Categories
CESPE Academy Courses

Twin screw granulation 101

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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)

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 ConsiGmaTM -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:

ConsiGmaTM-25 demonstration with placebo
&
Introduction to granule characterization methods

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.

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.

COURSE PROGRAM

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

Twin-screw-granulation-101Download

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.

Categories
CESPE Academy Courses

Feeding 101

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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)

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 Sarah.Costers@UGent.be.

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.

COURSE PROGRAM

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

Feeding-101Download

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.