Quality Risk Management for Isolator Gloves

This article focuses on describing control measures intended to reduce the risk of glove damages, which can be linked to contamination (particulate or microbiological). Specific risks involving gloves are analyzed, assessed, and minimized by means of appropriate control measures. The aim is to demonstrate that the risk of contamination via isolator gloves cannot be mitigated by a single action, but rather that a combination of several preventative measures is required. Important control measures for the safe handling of gloves at barrier systems include the observation of glove functional use, personnel training, and monitoring control measures. This observation of the glove functional use can represent a higher or lower good manufacturing practice (GMP) risk for the product, depending on the intervention. The handling of the gloves and their use should be documented accordingly and evaluated in a risk assessment. The risk analysis defines measures that are part of the quality risk management for gloves and contribute to the safe production of sterile pharmaceuticals. This raises the question as to the point from which an isolator is at risk of microbiological contamination following damage to a glove, or what size of pinhole in a glove represents a risk. This article works on the assumption that this question can only be answered by means of glove quality risk management.