FAQs and practical applications about EMPQ, an important regulatory mandate to safeguard product integrity and patient safety
Understanding Environmental Monitoring Performance Qualification (EMPQ) is essential for maintaining an effective and compliant cleanroom. This article addresses common queries and provides clarity on how newly constructed or significantly renovated facilities can meet the rigorous microbial and particulate standards required for safe products.
Based on the recently published webinar “CCS Blind Spots: Elevating Cleanroom Validation through Risk-Based EMPQ Strategies”, hosted by Ziva Abraham, President and Founder of Microrite, Inc., and Doug Botkin, Scientific Portfolio Specialist of Charles River, we’ll explore baseline sampling, risk-based monitoring, and the use of consistent microbial identification systems. Learn how to enhance your contamination control strategies and align operations with pharmaceutical regulatory expectations.
An EMPQ serves as an environmental monitoring validation step, ensuring that cleanrooms and other controlled environments meet the microbial and particulate standards necessary to prevent contamination during production. This process maintains product safety and compliance with regulatory standards. Read more >
Charles River’s QC microbiology testing portfolio brings you modern products and services that deliver accurate, relevant, and reliable data to allow you to make confident decisions on your product quality and contamination control. Our unique combination of Endosafe® endotoxin testing, Celsis® rapid microbial detection, and Accugenix® microbial identification and strain typing keeps your manufacturing operations running efficiently and smoothly, lowers your cost to manufacture, and protects your reputation.
