TRAINING: PHARMACEUTICAL STEAM

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

PROCESS : Pure fluids

Target : Expert / Intermediate

DURATION : 7 hours

NUMBER OF PARTICIPANTS PER SESSION : from 5 to 7 people

Paid training :
Prices on request

Content

  • 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

Prerequisites

Technical foundation

Target audience

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

Teaching méthods

Room with projector
Support
Evaluation and course completion certificate

Validation of training module

Final test and completion certificate

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