PDA 542.1 Developing a Microbial Monitoring Plan and Leveraging New Technologies for Effective Sterility Assurance in Aseptic Processes

A strong microbial monitoring plan and a leveraging/introduction of new technologies should be used for all sterile medicinal products and sterile active substances. As required by the principles of Quality Risk Management, this ensures that microbial, particulate and pyrogen contamination associated with microbes is prevented in the final product.

This training course provides tools, rationales and guidelines for designing a strong cleanroom microbial monitoring plan and for leveraging/introducing new technologies for effective sterility assurance in aseptic processes.

Specific topics include:

• FDA and EU GMPs requirements for total particle and microbial environmental monitoring for aseptic processes
• Design of an environmental monitoring plan based on risk assessment and process analysis
• New technologies and instruments for environmental monitoring: feature, scientific description and benefits
• New technologies and instruments for environmental monitoring implementation: FDA and EU GMP requirements and implementation/validation steps

1. Design a microbial monitoring plan for an effective sterility assurance in aseptic processes
2. Explain the implementation of new technologies for an effective sterility assurance in aseptic processes