Through this conversation, Christine Walton helps clarify the intent and application of USP <1119> and <1119.1>, positioning them not as prescriptive rules but as flexible, risk-based frameworks for modern bioburden testing. She emphasizes that true compliance and control come from scientific justification and process understanding, ensuring manufacturers can adapt their methods with confidence, precision, and regulatory alignment as industry standards evolve.
USP 1119 and 1119.1: The Future of Risk-Based Bioburden Testing Standards
Published In: Contract Pharma
November 5, 2025
Christine Walton
Senior Scientist
Christine Walton is a senior scientist with nearly two decades of laboratory experience supporting product quality and regulatory compliance in the medical device and pharmaceutical industries. She is highly skilled in microbiological consulting and testing per USP <60>, <61>, and <62> standards, along with environmental and water monitoring. Her expertise extends to biocompatibility and endoscope reprocessing programs, with complementary experience in bioburden testing. Christine has provided technical consultation to the FDA and CDC on endoscope microbiological screening and is recognized for her ability to align scientific precision with regulatory expectations.
