Control of Particulate and Microbial Contamination in Manufacturing of Sterile and Non-Sterile Drugs

Réf. : THF2

Intervenant(s) : Elodie PASTRE or Clémence PRETTE
Length : 14 hours (2 days)
Price : 1200
Trained people : 2025-6
Satisfaction rate : 85 %

Trainings EN

Type of training

In-house or inter-site

Target audience

Quality Assurance and Sterility Assurance Manager, Management and Production staff, Management and support service personnel (production methods, qualification/validation, maintenance, microbiology laboratory, etc.), Management and Quality Control personnel of the pharmaceutical, cosmetic, medical or biotechnological human and veterinary industries.

Pre-requisites

no pre-requisites

Teaching goals

  • Identify applicable international standards
  • Identify particulate and microbial contaminants causing deviations on site
  • Identify all the elements of its ZAC (HVAC, personal flow, material flow, layout of zones,…)
  • Know the terms of Qualification / Classification and especially Monitoring allowing to participate in field investigations in the case of proven contamination
  • Integrate the behavioral requirements (hygiene, gowning and activity in ZAC) to be put into practice on a daily basis and in correlation with their function (practices described and adapted according to the group present)
  • Integrate the particularities of the different configurations used for aseptic distribution processes and alternative processes
  • Identify the operations of Cleaning and Disinfection of the premises

Content of the training course

  • Identify the international texts available for the control of particulate and microbial contaminants,
  • Define, characterize and classify the different types of contaminants,
  • Describe the different elements constituting a cleanroom to be able to identify in situ the risks of contamination in your cleanrooms,
  • Retain the key points of the Qualification, Classification and Monitoring strategies to lead an investigation and interpret the associated results,
  • Discuss general hygiene measures and dressing practices to implement in your activities to control entries to ZAC,
  • Adopt good behavioral practices in correlation with your activities,
  • Distinguish the different configurations that can be used to manufacture sterile drugs,
  • Describe the good aseptic practices for Class A and discern the expectations of the aseptic simulation process,
  • Cite the main steps of a non-critical surface decontamination process in premises and understand the associated issues related to environmental monitoring

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
  • 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.