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 and course completion certificate

Validation de formation

Final test and completion certificate