Manufacturers of sterile drug products are required by the FDA to undertake disinfectant qualification studies to determine the effectiveness of their disinfecting agents. A new whitepaper, "Disinfectant Qualifications: Insight and Perspective," answers the most frequently asked questions about conducting a successful study. Download the paper from Microtest Laboratories at http://microtestlabs.com/disinfectant-qualifications.
Disinfectant qualification studies provide aseptic manufacturers with detailed information on their use of disinfectants, the level of their effectiveness, and the appropriateness of their use. With variables such as surfaces, disinfectants used, and organisms, it is imperative that disinfectant studies be carried out correctly and thoroughly.
The whitepaper, in a question and answer format, reviews the methodology involved in a disinfectant qualification study and explains what is to be expected when one is initiated. Answers are provided to such FAQs as:
- What companies should perform such studies?
- Why should the studies be undertaken?
- How are the studies executed?
- What should be included?
- How long is the study process?
How much does a study cost?
The whitepaper is authored by three Microtest Laboratory regulatory microbiology and contract laboratory experts with a combined 41 years of experience: Deborah Ensign, Shawn Sherry and Kate Bloomrose.
With FDA regulations requiring clean rooms to meet prescribed standards, a thorough, well conducted disinfectant study will not only help manufacturers of sterile drug products meet FDA regulations, but also protect product integrity and safety.