At the DITF, a new biological test method has been added to the range of tests for cleanroom garments: the Realistic Bacterial Barrier (ReBa2) test method, which was developed in collaboration with Dastex Reinraumzubehör GmbH & Co. KG.
Particularly in the manufacture of sterile pharmaceuticals in cleanrooms, but also in other life science areas, bacteria, skin flakes and fiber particles that can be emitted from people and their clothing pose a risk to the products manufactured in the cleanroom. Cleanroom garments have the task of minimizing this risk. To assess the barrier function of cleanroom garments, the “bacterial penetration” through the cleanroom garment textile is determined, among other things. The test methods used up to now have not been able to convincingly answer the question of realistic test conditions: How many bacteria from the human skin flora pass through the cleanroom garments to the outside when they are worn? The new ReBa2 test method largely reproduces this situation, enabling a meaningful determination of the bacterial penetration under realistic conditions.
The mechanical stress under movement, with a freely selectable load duration and with moderate moisture in the test system can be carried out in numerous test scenarios. In addition to the influence of intermediate garments worn under the cleanroom garments, the sweating process or wetting of the cleanroom garments by process media or disinfectants can also be examined. One of the most common bacteria of the skin flora – Staphylococcus epidermidis – is used as a test strain with a realistic load (in-oculum).
The test is carried out in the Biological Test Laboratory at the DITF Denkendorf and supplements the range of testing and development services for cleanroom textiles.
