Trends in Barrier Systems & Robotics

Objectives

The conference track on barrier systems will offer a range of case studies from pharmaceutical companies, providing valuable insights into the implementation, qualification and operation of isolators, RABS systems and robots. You will have the opportunity to engage in a discussion on the current state of the art and new technological developments in the field of barrier systems and pharmaceutical robotics. This discussion will take place with representatives from industry, authorities and system providers. You will gain hands-on experience with the current requirements of EU GMP Annex 1 for barrier systems, as well as an understanding of how these requirements are interpreted and verified by inspectors. You will also hear first-hand from experts from pharmaceutical companies about their experiences in their own operations.

Background

The most crucial concern for medicines produced using aseptic processes is protection against microbial contamination. In the current regulatory environment, there is an increasing requirement for greater separation between operating personnel and the product, in the form of an access barrier.

Two systems are currently available on the market: RABS (Restricted Access Barrier System) and isolators. However, it should be noted that the US FDA only designates isolators as advanced aseptic technology. A further consequence of the separation of operators and the production process is the increased use of glove-free isolators and robot technology in the aseptic environment.

The focus of this conference is on the current issues relating to barrier systems and robotics that have arisen from FDA regulations and the revised EU GMP Annex 1. The topic is addressed from the perspective of pharmaceutical operators, planners and engineers.

Target Audience

This event is intended for decision-makers in the fields of pharmaceutical production, automation, development and quality assurance/control. It is also aimed at engineers and planners who need to be well informed about current developments in the field of barrier systems and robotics.

 

You can find more detailed information at a later time.