Process simulation trials are designed to capture the routine production process as closely as possible, including formulation, filtration and filling stages. The process uses growth media instead of the active pharmaceutical ingredient (API).
At Assured Micro we can offer the capacity to incubate a batch of PSTs at the required temperatures. Normally for 7 days at 20-25°C followed by 7 days at 30-35°C. The units are then inspected at custom time points to suit during incubation for any contamination. A full report is generated to cover the incubation and inspection results. The units can also be growth promoted after incubation to validate suitability of media and incubation conditions to further qualify trial.
A full reconciliation service is performed to reconcile number of units pre and post incubation.