Abstract
Abstract – Validation is an obligatory for human health products such as food, medicine, cosmetics and auxiliary products due to international and national requirements. Hygroscopic chemicals, are the products require appropriate air humidity levels to be stored and validation should be made in accordance to relevant legislation. In this study, temperature (T), Relative Humidity (%RH) and Wet Bulb Temperature (WB) were measured in summer, autumn and winter in a company storage area of glycerol, glycose, fructose, galactose, riboflavin, niacin, folic acid, panthenoic acid, sulfuric acid, many fertilizer chemicals. Results of statistical analysis, histogram, detrended plot, skewnsess and kurtosis revealed that measurement data-set did not exhibited normal distribution pattern. Therefore, Mann-Whitney-U test was used to define significant difference in data-set. A corelation analysis was applied to determine the effect of temperature, %RH and WB on each other. A regression analysis and modeling was carried out to explain the relationship. Finaly, Fstatistic, tstatistic , %Sr values were calculated for the validation after removing outliers. In order to protect the shelf life of hygroscopic chemicals, the relative humidity increase rate has been provided without increasing the temperature by the developed modeling.
Key words; Validation, Hygroscopic Chemicals, Relative Humidity, Wet-Bulb, Correlation- Regression-Modeling
Introduction
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