A standardized risk assessment tool enabling a harmonized approach for selection and definition of environmental monitoring points

Frederic Ayers, Research Scientist, Eli Lilli, Manshi Patel, Associate Director – Microbial Control and Sterile Support, MSD and Dawn Watson, Director, Sterile & Validation Center of Excellence, MSD will take you through a global risk-based assessment tool for establishing EM Performance Qualification (PQ) locations and transitioning to a routine monitoring program. There will be an opportunity to put your questions to our subject matter experts in a Q&A session that will follow.

The problem:
Historically, Environmental Monitoring (EM) programs were designed based on higher-risk aseptic processes or opinions vs. an objective risk-based approach.
Applying traditional EM design principles to barrier/isolator systems can introduce more risk than benefit.
Non-value added monitoring leads to increased costs and resources.
Non-standardized EM approaches increase the risk of regulatory scrutiny and non-compliance.

BioPhorum’s EM team has created:
A clearly defined global risk-based assessment tool for establishing EM Performance Qualification (PQ) locations and transitioning to a routine monitoring program.

Allowing:
An industry-aligned approach for determining the most appropriate monitoring locations.
Alignment in approach amongst industry subject matter experts (SMEs) and regulatory authorities.
State-of-the-art EM Programs that are representative, effective, and efficient based on objectively calculated risks.