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Qualification of a purified water loop

A3P Training 26 October 2017 QUAL01 800 € HT (1 day)

PETAT - ACM Pharma & Samah RINGA - Suez

PUBLIC

  • Industry executive and technician in charge of installing or maintaining a water loop.
  • Quality staff in charge of qualification and monitoring of water loops.
  • Design office specializing in the design of water treatment facilities.
OBJECTIFS

• Regulatory Reminders of industrial water in pharmaceutical and cosmetic medium.

• Different sources of water and their characteristics.

• Define the steps and essential actions to ensure in time, the microbiological quality of the water produced.

• Present the essential steps to master to successfully design and installation of a water loop.

• Describe the essential characteristics of microbiological contamination of pharmaceutical waters and monitoring modes.

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.
For a good follow-up of the internship, the trainee has one or more course materials in digital version and in paper version.
PROGRAM  
This training presents the general industrial water in pharmaceuticals and cosmetics, different production systems of purified water and highly purified, essential principles of qualification, microbiology and industrial water microbiological control of waters.
Reminders on the water composition and its different origins
Water: an environment both simple and complexOverview of industrial water in pharmaceuticals and cosmetics
• The different origins of the waters and their characteristics
• Regulatory reminders of industrial waters in pharmaceutical and cosmetic environments
• Microbiological and physicochemical quality requirements

The different purified water production systems and highly purified
• Purification techniques
• Techniques for controlling contamination
• Advantages and disadvantages of different technologies

The essential principles of qualification
• Criteria of choice according to the final needs of the user
• Design and installation qualification
• Operational and performance qualification

Microbiology of industrial water
• The different types of microorganisms encountered in industrial waters
• Survival and development of microorganisms in waters (flora characteristic of purified water)
• Constitution and evolution of biofilms and their consequencesmicrobiological control of waters
• Traditional or alternative control methods
• Identification of microorganisms
• Interpretation of results: what to do with an OOS result and where to bring the action according to the microbiological information obtained in the laboratory?

Exchanges around types of production patterns
• Discussion - summary - restitution
• Conclusion

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

Satisfaction questionnaire

   
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

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