This paper describes a systematic approach to the evaluation, equipment qualification, and deployment of automated colony counting systems, which can be applied by biopharmaceutical companies wanting to take advantage of the numerous benefits.
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Slide Deck – A Standardized Risk Assessment Tool and Harmonized Approach for Selection and Definition of Environmental Monitoring points
The slides that support the webinar presentation ‘An industry perspective on common practise in forced degradation studies of biopharmaceuticals’, presented on 15 June 2021.
Environmental Monitoring (EM): A harmonized risk-based approach to selecting monitoring points and defining monitoring plans
The purpose of an EM risk assessment (RA) is to provide information to determine how to distribute monitoring to best verify that processes are operating under control. This step-by step guidance covers the EM RA process and provides recommendations on monitoring sites and methods based on the relative probability of contamination industry guidance addresses these needs and attempts to capture best practices in a useable ‘toolkit’ format. The guide incorporates good practices from biopharmaceutical manufacturers and adheres to current regulatory guidelines.
Environmental monitoring (EM): Continuous microbiological EM for process understanding and reduced interventions in aseptic manufacturing
This paper provides recommendations for quality oversight, manufacturing operations, and industry perspective of regulatory expectations to enable aseptic facilities to move toward real-time and continuous microbiological environmental monitoring, thereby reducing interventions and future replacement of Grade A settle plates and nonremote active air sampling. The replacement of traditional monitoring with biofluorescent particle-counting systems provides an improvement in process understanding and product safety and reduces operator manipulations, assuring product quality and real-time process verification. The future state pharmaceutical technology roadmaps include gloveless isolators with real-time and continuous monitoring for aseptic manufacturing.
This Excel spreadsheet tool compliments the guidance document ‘Environmental monitoring: harmonized risk-based approach to selecting monitoring points and defining monitoring plans’. This allows the user to assess a room against six factors, the amenability of equipment and surfaces to cleaning and sanitization, personnel presence and flow, material flow, proximity to open product or exposed direct product contact material, the need for interventions/operations and their complexity, frequency of intervention and score them