This reference examines laboratory techniques and FDA and industry perspectives on medical, food service, and consumer product applications of antimicrobials. It offers methods to conduct investigations of effectiveness that simulate use of consumer, food, and medical antimicrobials in real-world conditions and environments, validate neutralizing systems, develop reliable and functional antimicrobial products, and prevent infection, disease, and contamination. Additional topics include the importance of customer-valued quality attributes, such as low skin irritation and ease of use, label claims, regulatory procedures, and quality control, and clinical simulation protocols.
Overview: introduction to topical antimicrobials and their applications; food and drug administration perspective on topical antiseptic drug product development. Topical antimicrobials: clinical application of povidone-iodine as a topicalantimicrobial; quarternary ammonium compounds. Product applications: micro-organisms and disease; nosocomial infection. Food section: handwashing, gloving and disease transmission by the food preparer; handwashing and gloving for food protection I -examination of evidence. Consumer products: appropriateness of the health care personnel handwash test in assessing efficacy of consumer handwashing products; development of methods to evaluate efficacy of handwashing products for consumers. Testingmethods: overview; a guide for validation of neutralizer systems used in topical antimicrobial efficacy evaluations; testing methodology of preoperative skin preparation and surgical scrub as OTC drugs.