Aseptic Process Simulation (APS), from strategy to results

Intervenant(s) : Laurent MERLI or Pierre DEVAUX
Length : 14 hours (2 days)
Price : 1200
Trained people : 2025 - 16
Satisfaction rate : 92.8 %

Trainings EN

Type of training

In-house or inter-site

Target audience

Quality Assurance, Sterility Assurance, Production, Process Validation, Maintenance teams

Pre-requisites

no pre-requisites

Teaching goals

  • Identify what is an aseptic process?
  • Understand the regulations applicable to Aseptic Process Simulation (EU and US)
  • Be familiar with the changes brought by the update of Annex 1 of the European GMP
  • Understand the different stages involved in establishing and implementing an APS strategy on a sterile site
  • Know how to draw up the documentation required to produce an APS in compliance with the regulations
  • Understand the roles and responsibilities of the various stakeholders involved

Content of the training course

  • How to define an aseptic process:
    • What are the key steps in an aseptic process?
    • What are the critical stages ?
    • Why APS and not MFT (Media Fill Test)
  • Generality with APS:
    • Definition, objectives, conditions, means of implementation, frequency of realization, batch size, etc.
  • Regulations applicable in Europe:
    • Detailed explanation of the latest European GMP Annex 1
  • Differences and particularities with other applicable texts:
    • FDA Guidance aseptic 2004 pages 20 to 27
    • USFDA Questions and Answers on Current Good Manufacturing Practices-Production and Process Controls – Questions on Media Fill Test
    • PDA TR22 & TR28 – TR36 – PDA aseptic point to consider part 2
    • USP 797
    • PIC/S Recommendation on the Validation of Aseptic Processes
    • Japan Guideline on Manufacture of Sterile Medicinal Products by Aseptic Processing 2011 – part related to aseptic simulation: section 20
    • WHO good manufacturing practices for sterile pharmaceutical products
    • PDA Points to consider 2023
  • How to design the APS Plan?
  • The key documents associated with an APS: from the drafting of a Strategy including risk analyses to the approval of the Report
  • The various actions to be simulated and validated
  • Validation in campaign mode using RABS and isolator
  • Personnel qualification and concept of interventions
  • Supervision of APS’s
  • Incubation times, reading and interpreting results

How the course is organised

Teaching and technical tools

  • Training materials.
  • Theoretical presentations, examples of concrete cases
  • Practical application exercises
  • Question and answer sessions

Tool for monitoring the implementation of the training results assessment

  • Attendance sheets.
  • Assessment tests of the acquisition of knowledge
  • Certificate of training.
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.