A3P International Congress
Live to South Africa

The manufacture of sterile drugs using an aseptic distribution process is subject to multiple risks of contamination. More and more , everything is being done to drive operators out of the critical class A and thus implement what is called Barrier Technology. Also all over the world, two models are now proposed for the new lines : RABS (Restricted Access Barrier System) and isolators.
Another possibility is also proposed for conventional lines in place , their revamping to tend towards the definition of RABS.

This workshop proposes to clearly define what an aseptic distribution process is and what RABS and isolators are, by presenting the differences between them and the benefits /disavantages of these two design models. Once this presentation is made, this workshop aims to identify the key points to challenge in the drafting of your URS whether for the purchase of a new line or the modification of an existing line.

4 key points emerge for our barrier technologies :

• Ensure the protection of the critical class A to the class B outdoor environment by installing a robust technological barrier between A and B for RABS in order to exclude open door interventions as much as possible.
• Control of interventions : management of the interventions and control of glove/sleeve systems
• Design of class A and the associated aseptic process : management of the design of the different equipment and surfaces inside the critical area to make the process and its environment coexist (possible)
• Process control and associated critical pharmaceutical operations : Sterilizing filtration , aseptic process simulation, environmental monitoring, cleaning/désinfection operations, transfer systems

Whether you are beginner or more experienced, this workshop relying on the expertise of Patrick Coppens specialized in the subject, will bring you a lot of practical and technical informations and will allow you to understand where you must go tomorrow in terms of aseptic distribution line to be in accordance with the main international standards on the subject such as FDA guidelines or Annex 1 of the European GMPs.