| 摘要: | 西藥原料藥產業包含有機化學合成、天然物萃取純化、微生物的發酵或發酵後半合成，主要製程技術在回收、萃取、分離、純化及製劑配方。由一般化學品製備者，主要製程技術為複雜的有機合成及分離純化。西藥原材料包括一般化學品、天然動植物抽取、微生物菌種、發酵及基因工程或細胞融合之蛋白質相關的組織細胞等，其中以一般化學原料占大宗。靜電為大自然中的一種自然現象，由於大部分的物質都可能產生靜電，當在一定條件下兩種不同物質互相摩擦、接觸、分離起電，就有可能產生靜電，因此幾乎所有的人都會接觸到靜電。在化學、石油、塗料、塑膠、印刷及電子等產業，容易因靜電危害的問題造成火災爆炸之危害，從而造成人員傷亡及財物損失。因此靜電危害的問題及所造成危害事故越來越引起人們的關注。本研究以國內某西藥原料藥製造廠為例，來探討有機化學合成作業場所之靜電危害及改善之作法。針對有機化學合成作業場所各生產製程作業以風險分析方法：初步危害分析（Preliminary Hazard Analysis, PHA）的角度來分析有機化學合成作業場所各生產製程作業程序，本次危害風險評估只針對各生產製程作業中之靜電危害進行分析。經由初步危害分析（PHA）結果，有機化學合成作業場所屬於靜電危害之高風險場所，針對風險等級較高之危害加以改善及防治，以求降低其風險等級與災害發生之機率，能將其靜電危害風險降至可接受之風險。
The industry of active pharmaceutical ingredients includes organic chemosynthesis, extraction and purification from the natural products, fermentation of microbes or semisynthesis after fermentation. The main process technologies are recall, extraction, isolation, purification, and preparation formula. For the preparation of the general chemical products, the main process technologies contain the complicated organic synthesis, isolation and purification. The active pharmaceutical ingredients include the general chemical products, extraction from the animals or plants, strains of the microbes, fermentation, and genetic engineering or the protein-related tissue cells of cell hybridization etc., and among all, the chemical products represent for the majority.Static electricity is one of the natural phenomena in the nature for most materials are possibly able to create static electricity. With the fact that the static electricity may be created by having two surfaces of different materials friction, contact and separate, most people will have the chance to feel the static electricity. Among the industries of chemical, petrochemical, coating, plastic, printing, or electronics, it is not rare to find the electrostatic hazard problems caused fire explosion which leads to staff casualty and property damages. Consequently, the problems of electrostatic hazard as well as the hazardous accidents caused are gradually catching more and more attention from the public.This research is to take a domestic active pharmaceutical ingredients manufacturer as an example for case study and to investigate the electrostatic hazard and improvement at the organic chemosynthesis workplace. For the operational processes at the organic chemosynthesis workplace, the risk analysis method, Preliminary Hazard Analysis (PHA) is applied and to analyze the operational processes at the organic chemosynthesis workplace from the angle of PHA and the hazardous risk assessment is implemented to analyze the electrostatic hazard of every single operational process. With the analysis results of PHA in all of the operational processes at the organic chemosynthesis workplace, this workplace is defined as the high risk area of electrostatic hazard. For the hazard with higher hazardous risk level, improvement and prevention shall be implemented in order to decrease the risk level as well as probability of hazard occurrence so that the risk of electrostatic hazard can also be reduced to the acceptable level. |
