Description
Isolator gloves are an important component of the barrier system – however, their number and management should be tailored to the process. This presentation addresses glove management in the context of Annex 1 and the Contamination Control Strategy (CCS). It focuses on the risk-based determination of the required number of glove ports, their integration into the CCS, and the question of when it is appropriate to consider a reduction without compromising process protection.

What will participants learn?
Participants will gain insights into how to critically assess the number and arrangement of isolator gloves, weigh up risks against operational requirements, and justify their decisions clearly within the CCS. Why glove management can be crucial for maintaining barrier integrity.

Target audience
The presentation is aimed at specialists in aseptic manufacturing, quality assurance, microbiology, engineering and validation, as well as those responsible for isolators or the Contamination Control Strategy.

Prerequisites
A basic understanding of aseptic processes and isolator technology is helpful. An in-depth knowledge of Annex 1 is not required.