• Journal of Pharmaceutical Investigation
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• 제37권6호
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• pp.329-338
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• 2007

The quality assurance issue of drug products is more important than the general product because it is highly related to the human health and life. In this reason, the regulatory guide lines have continuously been intensified all around the world. In order to achieve effective quality assurance and real-time product release (RTPR) of drug products, process analytical technology (PAT), which can analyze and control a manufacturing process, has been proposed from the United States. With the PAT process, we can obtain significant process features of materials, quality characteristics and product capabilities from a raw material to the final product in the real-time procedure. PAT can also be utilized to process validation using information system that can analyze the risk of drug products through out an entire product life-cycle. In this paper, we first offered a new concept for the off-line process design methods to prepare the improved quality assurance restrictions and a real-time control method by establishing an information system. We also introduced an automatic inspection system by obtaining surrogate variables based on drug product formulations. Finally, we proposed an advanced PAT concept using validation and feedback principles through out the entire life-cycle of drug product manufacturing processes.

• 기술혁신연구
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• 제7권1호
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• pp.36-59
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• 1999

Fundamental advances in the biotechnologies are exerting a profound influence on the health care, agricultural, industrial chemical, environmental, and other industrial fields. Korean government are now more and more realizing the importance of biotechnology as a main technology for the 21st century. But any technical progress is largely the result of a complex set of relationships among the firms, institutions and others involved in development. So understanding the complexity is very important to make promoting strategies and it is even critical in the field of biotechnology. The reason is that commercialization of research results in biotechnology is strongly related with the national science bases provided by academic and public institutes. And its applicable industrial sectors are very diverse. So it is very important to make a effective collaboration system among many R&D related agents. This article discusses and compares both USA and Japanese framework of national innovation systems in the field of biotechnology. The American Innovation system encourages basic research in the biological sciences, and fosters the creation of small venture firms that focus on the development of novel products. America's peculiar incentive structure, derived from its research and educational system, financial system, and regulatory environment has driven USA labs and firms to the forefront of many biotechnology fields. The Japanese institutional environment in contrast, supported the strategy of building production expertise. Firms were urged to use the new techniques as a way of leapfrogging into a second generation of bio-products, in that cost and production advantages count. But the strategy was not effective as expected and Japanese firms have remained competent but not prominent rivals. The differing situations in USA and Japan with regard to biotechnology have many suggestions for our bioindustry. In the conclusion of this article, we translate USA and Japan's experiences to some suggestions which guide for promoting Korea's biotechnology R&D and commercialization activities.

• 한국지진공학회논문집
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• 제25권6호
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• pp.261-266
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• 2021

Nuclear power plants in Korea were designed and evaluated based on the NRC's Regulatory Guide 1.60, a design response spectrum for nuclear power plants. However, it can be seen that the seismic motion characteristics are different when analyzing the Gyeongju earthquake and the Pohang earthquake that has recently occurred in Korea. Compared to the design response spectrum, seismic motion characteristics in Korea have a larger spectral acceleration in the high-frequency region. Therefore, in the case of equipment with a high natural frequency installed in a nuclear power plant, seismic performance may be reduced by reflecting the characteristics of domestic seismic motions. The failure modes of the equipment are typically structural failure and functional failure, with an anchorage failure being a representative type of structural failure. In this study, comparative analyses were performed to decide whether to consider the inelastic behavior of the anchorage or not. As a result, it was confirmed that the seismic performance of the anchorages could be increased by considering the inelastic behavior of an anchorage.

• 한국지진공학회논문집
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• 제27권1호
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• pp.69-75
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• 2023

In Korea, most nuclear power plants were designed based on the design response spectrum of Regulatory Guide 1.60 of the NRC. However, in the case of earthquakes occurring in the country, the characteristics of seismic motions in Korea and the design response spectrum differed. The seismic motion in Korea had a higher spectral acceleration in the high-frequency range compared to the design response spectrum. The seismic capacity may be reduced when evaluating the seismic performance of the equipment with high-frequency earthquakes compared with what is evaluated by the design response spectrum for the equipment with a high natural frequency. Therefore, EPRI proposed the inelastic energy absorption factor for the equipment anchorage. In this study, the seismic performance of welding anchorage was evaluated by considering domestic seismic characteristics and EPRI's inelastic energy absorption factor. In order to reflect the characteristics of domestic earthquakes, the uniform hazard response spectrum (UHRS) of Uljin was used. Moreover, the seismic performance of the equipment was evaluated with a design response spectrum of R.G.1.60 and a uniform hazard response spectrum (UHRS) as seismic inputs. As a result, it was confirmed that the seismic performance of the weld anchorage could be increased when the inelastic energy absorption factor is used. Also, a comparative analysis was performed on the seismic capacity of the anchorage of equipment by the welding and the extended bolt.

• Safety and Health at Work
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• 제15권2호
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• pp.228-235
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• 2024

Background: Glove reuse poses risks, as chemicals can persist even after cleaning. Decontamination methods like thermal aeration, recommended by US OSHA, vary in effectiveness. Some studies show promising results, while others emphasize the importance of considering both permeation and tensile strength changes. This research advocates for informed glove reuse, emphasizing optimal thermal aeration temperatures and providing evidence to guide users in maintaining protection efficiency. Methods: The investigation evaluated Neoprene and Nitrile gloves (22 mils). Permeation tests with toluene and acetone adhered to American Society for Testing Materials (ASTM) F739 standards. Decontamination optimization involved aeration at various temperatures. The experiment proceeded with a maximum of 22 re-exposure cycles. Tensile strength and elongation were assessed following ASTM D 412 protocols. Breakthrough time differences were statistically analyzed using t-test and ANOVA. Results: At room temperature, glove residuals decreased, and standardized breakthrough time (SBT)₂ was significantly lower than SBT₁, indicating reduced protection. Higher temperature decontamination accelerated residual removal, with ∆SBT (SBT₂/SBT₁) exceeding 100%, signifying restored protection. Tensile tests showed stable neoprene properties postdecontamination. Results underscore thermal aeration's efficacy for gloves reuse, emphasizing temperature's pivotal role. Findings recommend meticulous management strategies, especially post-breakthrough, to uphold glove-protective performance. Conclusions: Thermal aeration at 100℃ for 1 hour proves effective, restoring protection without compromising glove strength. The study, covering twenty cycles, suggests safe glove reuse with proper decontamination, reducing costs significantly. However, limitations in chemical-glove combinations and exclusive focus on specific gloves caution against broad generalization. The absence of regulatory directives on glove reuse highlight the importance of informed selection and rigorous decontamination validation for workplace safety practices.

• 시큐리티연구
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• 제25호
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• pp.185-208
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• 2010

이 연구는 현재 한국 산업보안교육과정의 개선과 보안교육 프로그램에 대하여 제시하였다. 현대인은 세상의 급격한 변화에 대응해야 하는 불안전한 세상에서 살고 있다. 전반적으로 현대인의 생활, 사회, 경제, 국제관계 그리고 보안리스크는 점차적으로 더 복잡성이 더해가고 있다. 이와 더불어 현대인의 업무형태, 교통수단, 여가, 그리고 통신수단은 급격하게 변화하고 있다. 우리가 살고 있는 세상은 과거의 변화의 추세로서 미래의 변화를 예측하는 것을 불가능하게 한다. 이러한 불안전한 세상에서의 현대의 모든 활동에서의 실제적인 결정에는 안전성을 우선하게 되었다. 글로벌 환경은 과거와는 다르게 급격한 변동성이 증가하여 산업보안에 대한 사회적인 기대는 모든 면에서 증가하고 있다. 세계화의 복잡성, 공공의 기대감, 법적인 규제의 요구조건, 다국적에 걸친 이슈, 재판관한상의 이슈, 범죄, 테러리즘, 앞선 정보기술, 사이버 공격, 전염병 등은 새로운 보안리스크 환경을 조성하였으며, 현대인의 삶에 큰 장애물로 등장하였다. 이러한 새로운 보안리스크에 대응하기 위하여 산업보안전문가의 양성이 필요하다. 그러나 대학교육이 보안전문가의 양성에 얼마나 밀접하게 관련되어 있는가? 아쉽게도 오늘날의 대학학위는 취업이나 더 향상된 기회를 보장하지는 못하지만, 지금까지는 실제적으로 대학교육은 더 좋은 직업을 구하는데 최상의 방법이다. 마찬가지로 보안교육과 경험은 좋은 직업을 찾는데 최고의 고려대상이며, 여기에 훈련 또한 중요한 고려요소이다. 현대기업에서의 보안업무는 다양한 리스크로부터 기업을 보호하는 업무에서 비즈니스 경쟁 우위를 확보하기 위한 새로운 원천으로 변화되고 있다. 따라서 보안 분야의 교육의 미래는 지속적인 성장에 비례하여 유망한 산업분야가 되었다. 오늘날 현대인들은 과거와 다르게 일상생활에서 보안에 대하여 더욱 민감하게 의식하면서 생활하고 있으므로, 여기에 가장 부합하는 전문교육과정과 대학교육에서는 새로운 위협요인에 대응하는 산업보안교육 프로그램이 수립되어야 한다.

• Journal of Radiation Protection and Research
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• 제25권4호
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• pp.233-239
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• 2000

원자력 시설의 정상 운영중 오염 음식물 섭취에 의한 피폭선량 평가모델 (미국 원자력규제위원회의 규제지침 1.109 모델)의 입력변수에 대한 민감도 분석을 3가지 음식물 (쌀, 엽채류, 우유)과 2가지 핵종 $(^{137}Cs,\;^{131}I)$에 대해 수행하였다. 입력변수 값의 표본추출은 Monte Ca린o 방법에 근거한 Latin hypercube sampling 기법을 사용하였다. 모델 예측결과에 대한 입력변수의 영향력 또는 중요도를 나타내는 민감도지수는 partial rank correlation coefficient 의해 정량적으로 나타냈다. 평가결과, 고려된 음식물과 핵종에 대해 농작물의 수율에 대한 차단계수의 비와 음식물의 소비율은 중요한 입력 변수로 나타났다. 그외 우유의 경우 사료에서 우유로의 전달계수와 젖소의 사료 섭취율도 한 중요한 입력변수로 나타났다. $^{137}Cs$ 침적의 경우에는 기후에 의한 핵종의 제거 반감기가, $^{131}I$ 침적의 경우에는 생산에서 소비까지의 지연시간이 상대적으로 중요한 입력변수였다.

• Journal of Radiation Protection and Research
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• 제37권3호
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• pp.116-122
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• 2012

미국 원자력규제위원회(U. S. NRC)에서 개발한 PAVAN 프로그램을 사용하여 기상자료의 통계처리방법에 따른 원자력발전소의 수명기간 중 발생할 수 있는 가상 사고시 단기 대기확산인자 값의 영향을 분석하였다. 대기확산을 평가하기 위한 기본요소는 기상자료이며, PAVAN에서는 대기안정도에 대한 풍향과 풍속의 발생빈도를 나타내는 결합빈도분포자료를 사용하여 평가한다. 고리와 월성 원자력발전소 부지에서 2006~2010년까지 5년간 관측된 기상자료를 사용하여 풍속등급의 분류방법(U. S. NRC 권고와 균등발생빈도 분류방법)과 평가에 적용되는 기상자료의 통계처리기간(1년, 2년, 3년, 4년, 5년)에 따른 결합빈도분포자료를 작성하여 단기 대기확산인자를 평가하였다. 평가결과, 두 원자력발전소 부지 모두 풍속등급의 분류에 따른 단기 대기확산인자 값의 영향은 미미한 반면 평가에 적용되는 기상자료의 분석기간은 상대적으로 중요한 영향을 나타냈는데, 최대값과 최소값의 비는 1.5배 이상의 차이를 보였다.

• 보건행정학회지
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• 제34권2호
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• pp.106-119
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• 2024

의약품 부족은 전 세계적으로 보건학적 위험을 초래할 수 있는 문제이다. 본 연구의 목적은 미국, 캐나다, 일부 유럽 국가에서 국가의 의약품 부족에 대응하는 정책을 비교하고, 시사점을 도출하고자 하였다. 본 연구는 'drug shortage'와 'stock-out'와 같은 키워드를 사용하여 검색엔진과 구글학술검색을 통해 검색된 보고서 및 논문들을 검토하였다. 미국은 의약품 제조 중단에 대한 보고시스템을 구축하고, 의약품 공급망 관리의 중요성을 강조하고 있다. 또한 의약품 부족에 대한 대응체계를 마련하고자, 정부부처와 민간기관 간 의약품 부족 테스크포스를 설립했다. 캐나다는 중앙 및 지방 정부, 민간 부문의 대표를 참여시켜 의약품 부족에 관한 이해관계자 운영위원회를 설립하고, 의약품 부족 문제에 대해 단계적 접근방식을 채택하고 있다. 유럽의약품청(European Medicines Agency)은 2019년 유럽 경제 지역(European Economic Area)의 의약품 부족 커뮤니케이션에 대한 지침을 발표하였다. 외국에서는 의약품 부족을 모니터링하고 적시에 대응하기 위해 다양한 이해관계자 간의 의사소통에 중점을 두고 있다는 점을 확인하였다. 국내에서도 의약품 수급불안정 문제가 지속되는 만큼, 전담조직을 구성하고 가이드라인을 마련하며, 정부, 제약사, 의약품 유통사 등 민간부문의 협의와 조정을 통해 문제를 개선하는 것이 필요하다.

• Nuclear Engineering and Technology
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• 제56권7호
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• pp.2875-2880
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• 2024

The development of nuclear power plants is in three phases. The first phase is a consideration before the decision on the NPP construction program is approved, the second phase is the preparatory work for making contracts and preparing for the construction of NPP after the NPP construction policy is approved, and the third phase is contracting, licensing and building the first NPP. As a volcanically active country, Indonesia contains over 130 active volcanoes that are part of the Pacific Ring of Fire. The volcanic aspect is one of the safety factors considered while deciding the location of an NPP. Research on the potential of natural external risks to the determination of nuclear power plants in Indonesia, including the volcanic aspect, has been conducted based on the safety reference or safety guide of the IAEA and the Nuclear Energy Regulatory Body (BAPETEN) Regulation. Due to technological advancements, safety needs have evolved so the existing Indonesia National Standard (SNI) must be updated to comply with BAPETEN regulations. The substance in SNI 18-2034-1990 relating to volcanic features seems less relevant in actual conditions, given that more complete and exact criteria for determining a site guarantee the safety and health of residents and surrounding the environment site. The study intends to conduct a gap analysis of volcanic issues in SNI and volcanic regulations. The method used is identification requirements for volcanic aspects in SNI 18-2034-1990 about Determining Site of Nuclear Reactor Guidance with BAPETEN Chairman Regulation (BCR) number 4 of 2018 about Nuclear Installation Site Evaluation Safety Provisions and BCR number 5 of 2015 about Evaluation of Nuclear Installation Sites for Volcanic Aspects, and analysis uses a qualitative method of inductive techniques. The outcome of this research applies to suggesting a revision of SNI number 18-2034-1990, especially the volcanic aspect.