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KMID : 1142220160110020193
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Regulatory Research on Food, Drug & Cosmetic
2016 Volume.11 No. 2 p.193 ~ p.200
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A Developmental Study on the Assessment of the Efficacy of Topical Antiseptics and Contact Lenses
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Kim Sang-Seop
Kwon Sun-Mi
Min Chung-Sik
Lee Rhee-Da
Jung Shin-Ae
Choi Yong-Kyu
Park Soon-Young
Kim Young-Lim
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Abstract
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MFDS (Ministry of Food and Drug Safety) provides standard methods for evaluating disinfection efficacy for contact lenses care products. Currently, the guideline suggests standard methods for evaluating three kinds of efficacies including disinfection about contact lenses care products which are used for the sanitary management and prevention of eye diseases. Especially, sanitary management propose undetailed explanation about process for bacterial preparation, counting of bacteria and use only foreign standard strains. For that reason, the sanitary management of guideline has low convenience and limited availability to domestic industries which want to get permission of products from MFDS. This research suggest Korean reference strain through considering of strain in current guideline and ingredient of disinfection among permitted contact lenses care products and add detailed explanation of processes about each of sanitary management that influence to results of test. Based on this study, we validated the established method in compliance with guideline of standard methods for evaluating disinfection efficacy of contact lenses care products with other microbial research institutes. It is expected that the developed method can contribute to the convenience and availability to domestic industry and researchers related to contact lenses care products.
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KEYWORD
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Quasi Drugs, Contact Lenses Care Products, Disinfection Efficacy
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