Application of Analysis of Variance for Vitamin B Injection Solution Defectives Reduction in the Pharmaceutical Industry

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Chatpon Mongkalig


The objective of this research was to study the defectives reduction in the aseptic filling process in the pharmaceutical industry. The major nonconforming problem was the soot particles on the inner surface of vitamin B injection solution tube in the aseptic filling process. Analysis of Variance (ANOVA) was applied to determine factors, which had a significant effect on defectives percentage and the optimal levels of the factors to reduce defectives percentage. For experimental design, a Completely Randomized Design (CRD) was generated with 3 factors as follows: 1) needle type 2) needle position and 3) machine speed. According to the Analysis of Variance (ANOVA), needle type factor had a significant effect on defectives percentage. From the interval plot, the 95% confidence intervals of defectives percentage of vitamin B injection solution aseptic filling problem occurred by the two needle types were not overlapped. Therefore, the mean defectives percentage produced by the proposed type 1 needles was significantly less than the mean defectives percentage produced by the type 2 needles of the case study. Additionally, it was found that when the proposed type 1 needles were used, the mean defectives percentage was 4.25%. The mean defectives percentage of the current process using the type 2 needles was 15.90%. It can be concluded that when the proposed type 1 needles were used after the improvement, the mean defectives percentage decreased by 11.65%. 

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