Risk-Based Viable and Non-Viable Monitoring Sampling Plan for Microbial Control Program within ISO 7 Cleanroom

Abstract

The project intends to present a sitespecific risk assessment in order to design a custom viable sampling plan for a compounding pharmacy, which aseptically prepares patient-specific therapies. Additionally, the project has the objective to streamline the current sampling plan by reducing non-value adding locations. The risk-based approach will consist of a touch point risk assessment and a traffic flow risk assessment during operational conditions. The compounding operations will be observed during operational conditions to identify frequently touched locations and traffic flow. A total of 15 samples derived from the risk assessments and analysis representing an 81.2% of reduction from the current sampling plan. Key Terms - Compounding, Environmental Monitoring Program (EMPQ), Parenteral, Touch Point, Traffic Flow, Viable/Non-Viable.