Adamenko G.V., Burak I.I.
Technology of the production of the combined antiseptic «Vitasept-SKI»
Abstract.
The aim of this study was to develop a technology for the antiseptic «Vitasept-SKI» production under the conditions of pharmacies and industry.
The work has been done with the use of physical-chemical, microbiological, toxicological and statistical methods.
The manufactured product for topical use, being a 0,5% solution of crystalline iodine in 72% ethyl alcohol, in terms of quality (authenticity, smell, transparence, color, pH, density, content of active substances) meets the requirements made on antiseptics, with a shelf life of 2 years. It belongs to a substantially non-toxic (V toxicity class) and low hazardous compounds (IV class of danger) with mild irritative (class 1), cumulative (Kcum>5,1) and
resorptive properties, has no skin irritating and sensitizing effect, is a hygienically safe and effective antiseptic with a reduction factor of more than 6 lg at 100% concentration, and more than 4 lg at 75% concentration for model - cultures staphylococci, Escherichia coli, Pseudomonas aeruginosa and Candida. While determining the microbiological purity significant changes and elevations of standard indicators of the total number of aerobic bacteria and fungi (in total) in 1 cm3, bacteria of Enterbacteriaceae family in 1 cm3, P. aeruginosa bacteria in 1 cm3, S. aureus bacteria in 1 cm3 were not found.
Working instruction concerning the new antiseptic production, which helps to optimize the manufacturing process under the conditions of pharmacios has been developed.
Starting production process procedures that will optimize the technological process and produce alcohol solution for external use «Vitasept-SKI» industrially have also been elaborated.
The designed antiseptic «Vitasept-SKI» for external use can be recommended for the treatment of patients’ injection and surgery field. It may also be used to sanitize the hands of the staff on the performance of medical manipulations in health care organizations.
Key words: аntiseptic, technology, operating instructions, process flow diagram, ethyl alcohol, crystalline iodine, «Vitasept- SKI».
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