論文名稱: 藥品在流動床乾燥機之乾燥研究校所名稱: 東海大學高階經營管理碩士在職專班(研究所)畢業時間: 2018年 06月研究生: 李謀貫 指導教授 : 楊溥泰 博士論文摘要:本論文對藥品使用流動床乾燥機進行乾燥研究。研究發現未經濕度控制的流動床乾燥機雖可省時，但無法在適當的時間點得到合適的乾燥半成品顆粒粉末，常見藥物顆粒粉末有未乾燥完全或乾燥過度的現象，不但影響乾燥效能，且影響後續的製程安排和產品品質，不符合實際需求及成本效益。然而，利用室外溫度和濕度的偵測，對藥物乾燥可全程精確掌控，於適當時機得到合適的水份含量顆粒粉末，以利下游各階段的加工，讓相關製程都順暢，提升產品品質並減少不良品的浪費。研究結果，所設定的乾燥條件與參數方法，對使用Alcohol和純水造粒後的乾燥均有明顯效果：1. 使用以有機溶劑(Alcohol)造粒的藥物，以較室外稍高的低溫乾燥。2. 純水造粒的藥物，以較高的60℃上下溫度乾燥。關鍵字: 流動床乾燥機、有機溶劑、半成品、水份含量 Title of Thesis: A Study of Fluid Bed Dryer for Pharmaceutical Drugs DryingName of Institute: Tunghai UniversityExecutive Master of Business Administration ProgramGraduation Time: 06 / 2018Student Name: Mou-Kuan Lee Advisor Name: Pu-Tai YangAbstract:This paper discusses the use of fluidized bed dryer for pharmaceutical manufacturing in imperfect drying conditions. This study found that the general drying process without humidity control could reduce manufacturing time, but the results are not qualified. The current drying process yields granules with inconsistent dryness. As a result, the productivity and quality are affected. In this study, drug substance can be fully controlled with regulated ambient temperature and humidity. When the ideal drying conditions are achieved, the production becomes more cost- effective.Conditions with significant improvements in granulation are as follows: 1. For wet organic solvent granulation, the target drying temperature should be set slightly higher than its surrounding temperature.2. For water granulation, the target drying temperature should be set as approximately 60 °C.Keywords: Fluid Bed Dryer, Organic Solvents, Semi-Finished Products, Water Content.
