In 1994, the Food and Drug Administration (FDA) released the Tentative Final Monograph (TFM) requiring the product’s average reductions to meet the log10reduction requirements. Later, they changed this to the lower bounds of the 95% confidence intervals. Then they added the 70% responder rates. Both test and control products must meet 70% responder rates which creates a major obstacle. Now, the common control products cannot meet requirements. The industry has pushed back through the American Cleaning Institute.
Are You Ready to Start Your Next Preservative Efficacy Test?
November 27, 2017
Expanded Biofilm Services
June 14, 2017
What Equivalence Means
April 26, 2017
BioScience Laboratories, Inc. Biofilm Testing Capabilities
February 08, 2017
ISO 17025 ACCREDITATION
August 16, 2016
Anti-Biofilm Technologies: Pathways to Product Development
April 04, 2016
Russell Griggs, M.S., Presents Poster at AORN 2016
March 29, 2016
Neutralizing Your Product(s)
February 01, 2016
Materials Testing: Are You Stressed Out?
November 19, 2015
New Dedicated Materials Testing Lab
August 20, 2015