WORKSHOP: LYOPHILISATION (2nd Edition)

The theoretical-practical course to become familiar with the lyophilisation process and the freeze-drying equipment, to the point of being able to design a recipe. You will be able to understand and interpret the results through the process graphs, identifying the most common deffects and solving all the problems that may occur during a cycle. Furthermore, you will have been introduced to the equipment's qualification. maintenance and process validation.

This course is led with extensive experience in the specific fields related to the application, the equipment, and the process of lyophilization in different sectors.

The hybrid model that Comser have implemented, gives the possibility to participate in the Workshops from anywhere in the world.

Download the program and sign up now, places are limited!

The ideal training to dive into the world of lyophilisation

Introduction

Lyophilisation is a technique for stabilizing the product by removing the solvent by sublimation. The use of lyophilization within the pharmaceutical industry has increased in order to favor the shelf-life of drugs.

Approximately 50% of biopharmaceutical products are not stable in liquid form and need to be lyophilised. This course offers the opportunity to understand the lyophilisation process using a theoretical-practical approach at our facilities and with our freeze dryers. Professionals from different companies have already attended to the course, exposing their process and equipment problems, creating an atmosphere of debate and networking for all participants.

¿Who is it for?

This Workshop is aimed at people who work in the pharmaceutical, cosmetic, biotechnology or any industry related to the process and the application of freeze-drying. It is designed for all kinds of technicians working in the areas of production, validation, quality, technology, and anyone who wants to improve their knowledge on the freeze-drying process and the freeze drying equipment.

Lecturers
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Jaume Vallet Xicoy

CEO at COMSER

Founder of COMSER and expert in the freeze-drying process with more than 15 years of experience in the application of this technology in sectors such as pharmaceuticals or biotechnology.

 
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Robert Bullich i Buch

Freeze-drying consultant

Founder and director during more than 18 years in a process development and optimization laboratory of lyophilisation recipes.

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Alfons Ubach Casas

Freeze Drying Product Manager at COMSER

Responsible of Freeze Dry Solutions, COMSER's area dedicated to the development of knowledge in lyophilisation and freeze-drying equipment distribution.

PROGRAM STRUCTURE

Day 1: Fundamentals

  • ¿Lyophilisation? - Introduction
  • Physical bases of the process
  • Applicable regulations
  • Qualification of a freeze dryer
  • Product characterization

Workshop

  • Experiment approach
  • Samples preparation
  • Freeze dryer loading and cycle start

Day 2: Process development

  • Lyophilisation process
  • Auxiliar cycles of the process
  • CIP/SIP and Media Fill
  • Leak Test and filter integration test
  • Qualification of a freeze dryer - OQ Test

Workshop

  • Download the product
  • Analysis of results

Day 3: Results and problem solving

  • Diseño de una receta
  • Aspecto cosmético de una pastilla
  • Defectos comunes en un producto liofilizado
  • Escalado de un proceso

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