This presentation examines glove testing in accordance with Annex 1, which plays a central role in modern isolator and RABS systems for product and user protection. First, it explains the types of holes that can typically occur in gloves and glove ports – from microscopic leaks to mechanically caused damage. It then addresses the question of the extent to which such leaks pose a risk to the product and how they can compromise the integrity of an aseptic process.
Building on this, various methods of glove testing are presented, including common test procedures for checking tightness. A particular focus is placed on the pressure drop test, which is used as the standard method in many environments. This section highlights the parameters that need to be defined for a reliable and reproducible pressure drop test, such as test pressure, stabilization time, measurement duration, and acceptance criteria.