September 19, 2017 05:45:56 PM

Advances in Sterility Assurance: Single Use Devices and Rapid Microbiological Tests

Written by Katie Sternberg

Over the last decade significant technological advances have been made regarding the sterility and quality of new drug and microbiological products. New treatment and advancements in medical devices have led to an increase in quality of life and life expectancy for millions of patients.

In 2002, the FDA released its first progress report regarding the regulation of drug product quality. Many update programs and regulatory documents have. Most notably, the FDA guidance [1, updated 2015] recommends “building quality into products” by adopting new technological advances.

In late 2015 the FDA released a new program allowing pharmaceutical companies to pre-submit questions and proposals regarding the use of innovative technology. The Center for Drug Evaluation and Research (CDER) serves as the primary contact within FDA for companies interested in implementing new testing, processes, or proposed technology while offering direct support.

Learn more about some technological advances and how they improve sterility assurance for pharmaceutical manufacturing by downloading this paper.