Categories
CESPE Academy Courses

Process Analytical Technologies

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)


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


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.


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.


COURSE PROGRAM

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


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

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