The testing of the parts of a machine most prone to wear is a highly topical issue in the pharmaceutical field, since it is a way of ensuring work in total safety and to avoid potential contamination of the product during manufacture in isolators or restricted access barriers (RABS). Some of the most critical components at the greatest risk of deterioration and breakage during the manufacturing process are gloves, used for handling products in aseptic conditions.
The glove integrity test, with reference to the applicable regulations in force (Annex1 of the GMP) and regulated by ISO standards 14644-7 – Annex E.5 (positive pressure test), is strictly necessary and recommended before and after execution of the production batch or quality control. The purpose of the glove integrity tests is to ensure that the entire production process has been carried out without any external contamination of the product. In this context, Comecer has developed Speedy Glove, a device that can be adapted to any type of glove to be tested and is portable, automatic, and completely autonomous, without the need for external power supplies.
Speedy Glove was produced according to the cGMP regulations and is equipped with a touch screen that can be washed in its entirety with detergents and sterilised with VPHP (Vapor Phase Hydrogen Peroxide) so that it can also be used in the most demanding cleanrooms (Grade A or ISO 7).
Speedy Glove is classified as a Category 3 product and, according to GAMP5, as a nonconfigurable system.