Microbial Challenge In-Use Studies

By Brent Harlow

Regulatory agencies, like the FDA, are increasingly requiring microbial challenge in-use studies for certain parenteral drug products in which the container closure is breached prior to administration. These studies assess the risk of microbial contamination during handling and storage, ensuring patient safety. The process involves introducing low-level microorganisms into the drug product and storing it under recommended conditions. The growth of microorganisms is monitored to determine if the product supports their proliferation.

Results are interpreted based on changes in microorganism concentration over time, with a minimal increase considered acceptable. These studies are crucial for products administered to patients more than 4 hours after the container is opened. Although there are no specific FDA guidelines, it is expected that these studies be conducted when necessary.

An experienced CDMO specializing in performing microbial challenge in-use studies can assist you in meeting regulatory requirements. Ensure the safety and effectiveness of your parenteral drug products by finding the right partner for expert guidance and compliance with regulatory expectations. Learn more about how a partner with expertise can help you navigate the complex landscape of microbial challenge in-use studies and ensure the highest standards of patient care.