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Korea Society for Naval Science and Technology - Vol. 6 , No. 2

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Journal of the KNST - Vol. 6, No. 2, pp. 133-139
Abbreviation: KNST
ISSN: 2635-4926 (Print)
Print publication date 30 Jun 2023
Received 11 Apr 2023 Revised 28 Apr 2023 Accepted 28 Jun 2023
DOI: https://doi.org/10.31818/JKNST.2023.06.6.2.133
원료의약품 Amlodipine Camsylate 합성공정에서 교반속도에 따른 폭주반응 위험성 평가
박동하¹ ; 김철상¹ ; 김상중¹ ; 전진우² ; 박교식³^{, *}

1숭실대학교 일반대학원 안전보건융합공학과 박사과정

2숭실대학교 일반대학원 안전보건대학원 교수

3숭실대학교 일반대학원 안전보건융합공학과 교수
Risk Assessment of Runaway Reaction According to Stirring Rate in the Synthesis Process of Amlodipine Camsylate, an Active Pharmaceutical Ingredient
Dong Ha Park¹ ; Cheol Sang Kim¹ ; Sang Jung Kim¹ ; Jin Woo Jeon² ; Kyo Shik Park³^{, *}
1Ph.D. candidate, Dept. of Safety & Health Convergence Engineering, Soongsil University

2Professor, Safety & Convergence Graduate School, Soongsil University

3Professor, Dept. of Safety & Health Convergence Engineering, Soongsil University

Correspondence to : ^*Kyo-Sik Park Dept. of Safety & Health Convergence Engineering, Soongsil University 46, Sadang-ro, Dongjak-gu, Seoul, 07027, Republic of Korea Tel: +82-2-828-7348 E-mail: safetyguy@ssu.ac.kr
© 2023 Korea Society for Naval Science & Technology

초록

본 논문에서는 원료의약품 제조공정에서 화학반응에 의해서 제품이 생산되며 이때 화재 폭발사고가 자주 발생하고 그주된 원인은 화학반응 중 열매체, 교반속도, 원료 투입속도등이다. 이에 대한 실질적 화학반응 단계에서 사고원인분석을 통한 안전대책 연구는 많지 않다. 본 연구에서는 화학반응 단계에서 위험성을 알아보고자 교반속도에 따른 발열에 대한 실험을 진행하였다. 연구 대상 반응공정은 실제 원료의약픔 생산과정에서 합성하고 있는 제품을 대상으로 반응열량계(reaction calorimeter)를 이용하여 열적거동을 조사하고, 실제 제조 현장의 반응공정에서 교반속도의 영향에 따른 발열할수 있는 합성반응의 최대온도와 기술적 근거에 의한 최대온도를 비교해서 위험도를 예측하였다. 이러한 결과를 가지고 실제 제조현장에 적용하여 발열에 따른 폭주반응 위험성을 제어하는 안전대책을 제시하였다.

Abstract

Fire and/or explosion accident often occurs during chemical manufacturing process of active pharmaceutical ingredients (API) by a function of heat medium, stirring rate, feed rate of raw material, etc. In this study, an experiment was conducted on heat generation according to the stirring rate to find out the risk in the chemical reaction stage. Thermal behavior was investigated using a reaction calorimeter for products synthesized in the actual production of API. The risk was predicted by comparing the maximum temperature of the synthesis reaction that can generate heat due to the influence of the stirring rate in the reaction process at commercial scale with the maximum temperature based on the technical basis. With these results, safety measures to control the risk of runaway reaction due to heat generation were proposed by applying them to the commercial reactor.


Keywords: Runaway Reaction, Reaction Calorimeter, Active Pharmaceutical Ingredient, Cooling System, Human Error, Marine Accident 키워드: 폭주반응, 반응열량계, 원료의약품, 냉각시스템, 휴먼 에러, 해양사고

References


1.	W. S. Kim and K. W. Lee, “Hazard Evaluation of Runaway Reaction in Deboronation Process Using H2O2 in DIET Synthesis of Pharmaceutical Raw Material,” Journal of the Korean Institute of Gas, Vol. 22, No. 4, pp. 49–54, Aug. 2018.
2.	J. S. Lee, I. S. Han, and G. W. Lee, An evaluation of runaway reaction characteristics of the modified resol synthesis reaction using the RSST. J. Korean Soc. Saf, Vol.28, No. 7, pp. 19-24, 2013.
3.	KOSHA GUIDE P-67-2012, "Technical Guidance on Thermal Risk Assessment for Runaway Reaction Prevention," (2012)
4.	I. S. Han, K. W. Lee, and J. Y. Lee, “Characteristics of Thermal Hazard in Methylthioisocyanate Synthesis Reaction Process,” Journal of the Korean Society of Safety, Vol. 27, No. 5, pp. 77–87, Oct. 2012.
5.	Keun-Won Lee et al., Evaluation Techniques of Runaway Reaction Hazards in Chemical Process, Proceedings of Fire Science and Engineering Conference, pp. 242-247, 2003.
6.	H. S. Lee, and H. C. Yun, “A Study on the Rupture Disk Design and Application at the Two Phase Flow by Runaway Reaction at Batch Reactor,” Journal of the Korean Institute of Gas, Vol. 21, No. 3, pp. 1–8, Jun. 2017.
7.	K. H. Lee, W. S. Kim, J. W. Jun, Y. G. Joo, and K. S. Park, “The Risk Assessment of Runway Reaction in the Process of Fridel-Crafts Acylation for Synthesis Reaction,” Journal of the Korean Society of Safety, Vol. 36, No. 3, pp. 24–30, Jun. 2021.
8.	Hvalec, M., Goršek, A., and Glavič, “Experimental design of crystallization processing using taguchi method,” Acta Chim. Slov. Vol. 51, pp. 245-256, 2004.
9.	중앙해양안전심판원 해양사고 특별조사보고서(케미컬운반선 스톨트그로엔랜드폭발사고), 2021.