Categories
CESPE Academy Courses

Process Control and Optimization

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)



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.


COURSE PROGRAM

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


If you are interested in taking this course, please email sarah.costers@ugent.be or mgadbruy.debruyne@ugent.be.

Categories
CESPE Academy Courses

Process Analytical Technologies

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

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


COURSE PROGRAM

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


If you are interested in taking this course, please email sarah.costers@ugent.be or mgadbruy.debruyne@ugent.be.

Categories
CESPE Academy Courses

Lyophilization 101

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.


If you are interested in taking this course, please email sarah.costers@ugent.be or mgadbruy.debruyne@ugent.be.