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white process Heat sterilization: Principles, validation & production
Fundamental and practical aspects

MC11      

PUBLIC
Anyone involved in sterilization processes or manufacture of sterile products:
- Production
- Support Service
- Technical Service
- Quality department


PRE-REQUIS
Have a good understanding of the principles and the heat sterilization requirements

OBJECTIFS
• Have a good understanding of the basic principles and requirements of the heat sterilization.
• sterilization method with moist heat.
• Moist heat Case Study: know the possible actions in case of deviations.
• A method for sterilizing / depyrogenating by dry heat.
• Tunnel Case study: control of air flow and differential pressures
.
MOYENS PEDAGOGIQUES
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.
Pour un bon suivi du stage, le stagiaire dispose d’un ou plusieurs supports de cours en version numérique et en version papier.

Études des différentes méthodes et référentiels
Études de cas
.

 

 

PROGRAMME

 

NOTE MOYENNE
16 7

given by previous interns

DUREE
2 days
 


DATE
17 and 18 May 2017

FORMATEUR
Dominique SIERAKOWSKI
Expert lyophilisation, qualité et procédés aseptiques


TARIF
1 200 € HT
(Lunch included)


doc5
inscriptionmc

Have a good understanding of the basic principles and the heat sterilization requirements

• Repositories and regulatory definitions
• Sterilization Methods and application areas
• Thermal destruction parameters (F0, FH, FT)
• Critical parameters and Good Sterilisation Practices
n

The process of sterilization by moist heat
• Steam: production and quality criteria for autoclaves (dry saturated steam)
• Autoclaves

- Description and qualification
- Description and developmentsterilization cycles (porous fillers and liquid)
• Validation and control cycles
• Sterilization in place (SIP / SEP) equipment

- Design of equipment sterilized in place
- Description, validation and control cycles
• Maintains sterility before use

moist heat case study about possible actions in case of deviations

• Autoclave porous loads and problems of "wet load"
• Sterilization processes up tanks and fermentors
• Sterilization and drying stoppers (bags and sterilization systems "bulk")

A method for sterilizing / depyrogenating dry heat
• Description and qualification of sterilization ovens and tunnels
• Description, validation and monitoring of sterilization cycles / depyrogenation

tunnel case study: control of air flow and differential pressures

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
Dominique SIERAKOWSKI
dominiquesierakowskiExpert lyophilisation, qualité et procédés aseptiques Diplômé de l’Université de Biologie, il travaille depuis plus de 37 ans dans la production de produits injectables stériles (domaine des biotechnologies) où il a occupé différents postes comme responsable de production, responsable assurance qualité et chef de projets senior; missions durant lesquelles il a développé différentes expertises dans les domaines des procédés aseptiques, de la lyophilisation et de la qualité ainsi que la mise en oeuvre et la validation de procédés de nettoyage, stérilisation, remplissage aseptique et lyophilisation dans un environnement réglementaire américain, européen et Organisation Mondiale de la Santé.

Training A3P:
PROC01 - Lyophilisation 1 (initiation) : bonnes pratiques et bases de la lyophilisation
PROC02 - Lyophilisation 2 : développement et perfectionnement des connaissances
PROC03 - Lyophilisation 3 : expertise et maîtrise de la qualité
MC11- Stérilisation par la chaleur : principes, validation et production
BPF02 - Procédés aseptiques : simulation et filtration stérilisante
BPF03 - Gestion du risque qualité ICHQ9 des procédés aseptiques
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The A3P Association is a major player in the pharmaceutical and biotechnology industry.
Created in 1986, it contributes to the good development of the production of medicines and clean and sterile equipment, it runs a network of professionals 21 000, manufacturers and suppliers, as part of International Congress and technical days.

It now has over 1700 members who share their technical experience, scientific and regulatory.

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