Best Practices for Using Biological Indicators in GMP Environments
Sterilization in a GMP environment cannot be evaluated by temperature, pressure, or cycle time alone. Those parameters tell us whether the equipment operated as expected, but they do not directly demonstrate that the process was capable of inactivating resistant microorganisms. This is where a Biological indicator plays an important role. Biological indicators introduce a known population of resistant microorganisms into a sterilization process. After exposure and incubation, the result provides microbiological evidence of whether the cycle delivered the required sterilization conditions. Tailin provides biological indicators for several sterilization methods, including steam, vaporized hydrogen peroxide (VH₂O₂), hydrogen peroxide plasma, ethylene oxide, and dry heat. For pharmaceutical manufacturers and laboratories working under GMP requirements, choosing the right BI is only the beginning. Placement, handling, incubation, documentation, and investigation practices are e...