Analysis of factors affecting a glove integrity test in aseptic environment for pharmaceutical applications

In the field of pharmaceutical production, regulations are extremely severe and require validation procedures, which are used to monitor and prevent the possibility of microbiological and particulate contamination from outside of these drugs that are produced and handled within the isolators. These are phases in which the equipment used in the production processes is tested according to specific requirements, ensuring that its performance meets the stated standards. Automatic Glove Leak Testing System, known as AGLTS2, by Tema Sinergie company is a device designed to comply with the last release of EU GMP ANNEX I, published in August 2022 and effective from August 2023, reference regulation for the production of drugs, particularly injectable ones, and establishes the need to test glove integrity, at least before and after production. Gloves are tools that allow operators to handle drugs or other devices used for working with drugs within isolators, which are the aseptic and clean environments where pharmaceutical processes are carried out. The AGLTS2 complies with the international standard ISO 14644-7:2004 Annex E.5, which specifies to perform the glove test according to the Positive Pressure Decay Method. Validating the AGLTS2 means proving that the device can discriminate between intact gloves and perforated gloves, with a hole larger than 100 μm. This thesis aims to understand which external factors might influence the recipe, and specifically interfere with the system's ability to differentiate between an integer and a holed glove.