A range of factors must be considered when developing a topical antimicrobial for use in a healthcare personnel handwash, surgical scrub, or preoperative skin preparation. Antimicrobial effectiveness, low skin irritation, ease of use, and pleasing aesthetics are all essential if the product is to succeed. In addition, all facets of the product must comply with stringent regulatory requirements. With updated protocols and research, Topical Antimicrobials Testing and Evaluation, Second Edition comprehensively presents and reviews the latest techniques for testing antimicrobial compounds for effectiveness and regulatory compliance.
Topics include:
- The anatomical structure of the skin and skin microbiology relevant to product testing
- Use of antimicrobial products against specific microorganisms such as Staphylococcus and Streptococcus species
- Measurement of antimicrobial action of topical antimicrobials from experimental design, microbiological, biostatistical, and marketplace perspectives
- Various aspects of the topical antimicrobial products currently in common use in medical, food service, and consumer markets
- Statistical analysis and specific statistical designs for clinical trials
- Epistemological requirements in evaluating the effects of specific treatments
- Evaluation strategies and sample working protocols for hand and body soaps, food-handler antimicrobial products, and medical/healthcare industry antimicrobial products
The book is designed to inform industry and academia on the requirements to get products approved by the FDA and to market while also providing critical insight on ways to best service expanding markets.
Highlighting techniques for testing antibacterial compounds, this new edition of a bestseller handbook provides tips and tools for navigating the ins and outs of FDA approval procedures. It offers strategies for the servicing of expanding markets, outlines testing protocols, presents a range of testing techniques, and reviews their efficacy and appropriate use, It also demonstrates specific methods for testing the effectiveness and safety of preinjection and preoperative washes, healthcare and food workers hand washes and sanitizers, and other surgical scrubs.