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white process Autoclave, moist heat sterilization
Validation of critical parameters and controls management of aseptic components for maintaining sterility



- Responsible technician and Production
- Responsible technician and validation
- Responsible and Quality Assurance Technician
- Responsible technician and quality control
- Cleaning Project Manager


• Understand the principles of heat sterilization.
• Identify the applicable regulatory requirements.
• Validation and control of critical parameters of sterilization.
• Managing the preparation of components before, during and after sterilization

En début de session, grâce à un questionnaire, le formateur analyse le niveau de connaissances des professionnels sur le sujet ainsi que leurs attentes des connaissances à acquérir.
Le formateur adapte le programme de la formation en fonction du profil des différents participants. Un temps est consacré aux échanges d’expériences entre participants et avec le formateur.
For proper monitoring of the course, the student has one or more course materials in digital and in print.





1 day

21 2018 June 


800 € HT
(Déjeuner inclus)

This course covers heat sterilization principles, presents ways to improve productivity pre and post sterilization and explores solutions to the challenges currently encountered.
The training will pay special attention to the management and maintenance of the quality of heat and sterile status of sterile components. Accordingly, the packaging process and the type of packaging used, the types of biological indicators, types of chemical indicators, sterilization cycle of development, and the critical parameters will be discussed.


The regulatory requirements for the heat-sterilization

Principle of sterilization
• Different heat sterilization methods
• Design and operation of autoclaves for heat sterilization

Critical parameters for moist heat sterilization
• Physical Critical Parameter
• microbiological critical parameter
• Choice of biological indicators to be used in validation and routine compared to the sterilization method used


Qualification, requalification and autoclave validation (V-Cycle)
• Consideration to be considered before starting a project of qualification and validation of autoclave
• Bad practice and common mistakes

Management aseptic components before, during and after sterilization with moist heat
• Method of preparation in order to minimize variations and improve operational efficiency
• Monitoring of the sterilization cycles

Avoid common errors
(Eg. Remove or accept a certain component in the presence of water sterilized)

Évaluation des connaissances acquises et évaluation des actions d’améliorations entreprises et/ou envisagées

Questionnaire de satisfaction

Cette journée s’inscrit dans le cadre de la formation professionnelle.
N° Déclaration : 82 69 13448 69 Préf. Région Rhône-Alpes
SARL au capital de 10 000 Euros Siret 451 934 541 00025
walidelazabTechnical Services Manager Head of Technical Services of the life science division of STERIS Corporation, and currently provides technical support related to cleaning chemicals, disinfectants and insurance products for sterility and their application and validation. He holds a Masters in Industrial Pharmaceutical Sciences at the University of Liège in Belgium and is certified green belt (green beld) in continuous improvement. It is also an active member of the Parenteral Drug Association in Europe (European PDA), European Compliance Academy (ECA), PSI, etc. A3P It provides courses at the University of Liège (Belgium) for the industrial pharmacist Master and has also written several publications related to the control of cross contamination. Finally, he served as secretary to the UPIP-Vapi responsible pharmacists (QP) in Belgium.

A3P training:
MC12- Autoclave, moist heat sterilization


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