Management of Barrier Technologies (RABS and Isolator)

Intervenant(s) : Patrick COPPENS or Jules BOULICOT
Length : 2 days - (14 hours)
Price : 1200
Trained people : 2025 - 77
Satisfaction rate : 93.3 %

Trainings EN

Type of training

In-house

Target audience

Production, Maintenance, Qualification / Validation, Sterility Assurance, Operational Quality Assurance

Pre-requisites

No

Teaching goals

  • Identify and know the regulatory requirements
  • Master aseptic practices and identify associated risks
  • Know the technical fundamentals and constraints of Annex 1
  • Identify points of vigilance
  • Be able to put into practice on your site the notions acquired

Content of the training course

  • Reminder of regulatory requirements:
    • Eudralex – volume 4 Good Manufacturing Practice (GMP) guideline
    • Annex 1 GMP
  • Definition, technologies, aseptic practices and associated risks:
    • Definition and differences between RABS vs Isolator
    • Aseptic practices
    • Update on decontamination
  • Technical fundamentals – User expectations and constraints
    • Isolator project, the importance of understanding customer processes
    • Classification and management of air in the isolator / in the cleanroom
    • Glove management
    • EMS
    • Management of external connections and inputs/outputs
    • Mock up / FAT / SAT
  • Point of vigilance:
    • Disinfection cycle validation process in the isolator
    • Manufacturing process / specific manipulations
    • Managing moving parts
    • Management of environmental variables
  • Be able to put into practice on your site the acquired notions

How the course is organised

Teaching and technical tools

  • Training materials and regulatory documents.
  • Theoretical input, concrete case examples
  • Participatory pedagogy
  • Question and answer sessions

Tool for monitoring the implementation of the training results assessment

  • Attendance sheets
  • Assessment tests of the acquisition of knowledge
  • Training certificate
Download the training file

Registration and formalities

Registration

For all intra or inter-company registrations, please send your request to the following email address : contact@theraxel.fr .

An acknowledgment of receipt of your request will be sent to you as soon as possible

Training place

Our open-enrollment courses can be offered in Beaune (21200) or Dijon (21000).

For in-house training, please contact us.

Registration conditions

A minimum of 5 participants is required for the training to be provided. Below, THERAXEL reserves the right to postpone the scheduled session.

Upon receipt of your registration, Theraxel will send you an acknowledgment of receipt. The training agreement will be sent to you at the latest 1 month before the start of the training.

After the training has taken place, we will send you the invoice as well as the training certificate. From the date of issue of the invoice, payment must be made within 30 days at the latest.

Our prices

All prices are indicated in euros excluding taxes. The applicable VAT rate is 20%.

The prices indicated are in effect for the current year, and applicable for inter-company training.

The prices indicated are per participant and include the educational cost of the training, materials, lunch and breaks.

For intra-company requests, the request will be the subject of a personalized quote adapted to your needs. Contact us for more information.

People with disabilities

Accessibility for people with disabilities:

If you have a disability or are experiencing difficulties, you can contact our contact person: Maryline PERRAUD, at 03.80.25.94.30, so that we can study your request and adapt the form and content of the teaching methods implemented.

Practical information

  • Contact :

For any information, you can contact:

Séverine LAURY, Administrative contact person for the training department

Maryline PERRAUD, Disability Representative

Elodie PASTRE and Pierre DEVAUX, Educational Referents

Tél : 03.80.25.94.30

Mail : contact@theraxel.fr

Courrier : 16 Rue Sainte-Marguerite – 21200 Beaune

Sur place : du lundi au vendredi de 9h à 17h.