Sterility testing is an extremely important for pharmaceutical manufacturers as it confirms sterility of finished product released to the market for patient use. However, false positives can lead to delays in product being released, or potential loss of batches. We will explore the different approaches available for sterility testing focusing on why aseptic isolators integrated with H₂O₂ vapour bio-decontamination technology provide the most robust approach to reduce the risk of false positives.