FORMATION: PHARMACEUTICAL STEAM

Pure fluids
OBJECTIF: Master the different characteristics and standards relating to the production and distribution of pharmaceutical steam.

PROCESS : Pure fluids

Cible : Expert / Intermediate

LIEU : A convenir avec le client

DURATION : 7 hours

NUMBER OF PARTICIPANTS PER SESSION : from 5 to 7 people

Formation payante :
Tarifs sur demande

Contenu

  • WATER STEAM
- From water to gaseous state: which water steam? - Pharmaceutical approach and qualifying elements (Filtered - White - Clean - Pure) - The generation and production of steam - Fluid management: static - fluent - dynamic steam - Thermal Approach: saturation and overheating - Normative perspectives (EU-GMP, US-GMP; EN; ISO)
  • STEAM PROFILE QUALIFICATION : CONTROL OF THE PARAMETERS
- Pressure, temperature and flow - Relationship between P/T and non-condensable gases - Biocontamination and sterility: neither sterile nor sterilising - Conductivity: V tests, DTS, without additives, C (water, condensate) - Quality and overheating - Quality impact on the sterilisation
  • DISTRIBUTION NETWORKS AND BIOBURDEN
- Design and implementation objectives - The impact of the network on qualifications - The dimensioning and expansion of the pipework - Network contaminations - Insulation calculations - Practical tips and feedback

Prérequis

Technical foundation

Public

Supervisors/Managers, Engineerings offices, Project Managers, Technical Services and Quality Deparments

ACCESSIBLITE HANDICAP

Pour les personnes en situation de handicap, merci de nous contacter.

Moyens techniques

Room with projector Support Evaluation, Multiple-choice questions or practical scenarios

Validation de formation

Final test, Multiple-choice questions or practical scenarios