• 제목/요약/키워드: good manufacturing practice

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Elucidation of Intergranular Corrosion of UNS N08810 alloys (UNS N08810 합금의 입계부식손상과 원인 분석)

  • Kim, Youngsik;Hwangbo, Deok
    • Corrosion Science and Technology
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    • v.11 no.5
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    • pp.196-204
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    • 2012
  • Corrosion failure of petrochemical facilities is one of the difficulties in maintenance, since operating conditions of crude oil production, storage, and refinement are very aggressive. UNS N08810, which has been used for crude oil transportation pipes and storage tanks in petrochemical industries, shows good resistance to general corrosion and localized corrosion in several environments. Among its environments, UNS N08810 showed better corrosion resistance in fuel gas containing sulfuric acid and phosphoric acid and sulfur. However, ductility and toughness at high temperature over about $500^{\circ}C$ were greatly reduced due to microstructural change. In general, welding process is the representative method to join the parts in industrial components. Because the alloy by welding can be sensitized and corroded, the manufacturing process should be controlled. In this work, UNS N08810 was used and heat treatment conditions including solution and stabilization treatments were controlled. Oxalic acid etch test by ASTM A262 Practice A was done to evaluate the qualitative sensitization in room temperature. Huey test by ASTM A262 Practice C was done to evaluate the intergranular corrosion rate in boiling 65% $HNO_3$ solution. Also, the microstructure by thermal history was analyzed. Experimental alloy showed high intergranular corrosion rate and its corrosion mechanism was elucidated.

Valve Seat Design for Full Contact Effect Using Grey Relational Analysis (회색 관계 분석법을 이용한 누수 방지용 밸브 시트 설계)

  • Lee, Jung-Hee;Kang, Gyeong-Ah;Kwak, Jae-Seob
    • Journal of the Korean Society of Manufacturing Process Engineers
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    • v.17 no.4
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    • pp.17-22
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    • 2018
  • A glove valve regulates the flow in a pipeline as a kind of control valve. However, when the disc and seat contact, the valve structure can be distorted and flow can leak due to the elongation of the valve material under high pressure. The surface texture is not good enough to seal the contact surface (in practice) because the lapping process is usually done manually. Furthermore, assembly performance is analyzed by structural analysis. Compared with a standard seat, the newly designed seat had a smaller radial deformation and a larger longitudinal deformation. Therefore, the newly designed seat can maintain a tight and uniform contact with the disc with a reduced radial deformation and an expanded available seal area with an increased longitudinal deformation. The seal performance of the glove valve has been improved in a cost-effective manner.

Optimization for Drop and Lift of the SONAR Under the Limited Installment Space Using the GA (GA를 이용한 제한된 설치환경 하에서의 소나 투하 및 인양 장비의 최적화)

  • Park, Seong-Hak;Chung, Won-Jee;Kim, Hyo-Gon;Choi, Jong-Kap
    • Journal of the Korean Society of Manufacturing Technology Engineers
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    • v.25 no.5
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    • pp.321-328
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    • 2016
  • Cranes are generally used to drop or lift equipment or materials. The present study focuses on equipment used for dropping and lifting the sonar system for undersea exploration. This study deals with a GA-based MATLAB$^{(R)}$ simulation for the design optimization of a new overboarding prototype with a two degree-of-freedom mechanism, including a parallelogram link, which is efficient in sonar system operation and maintenance. First, the strengths and weaknesses of the existing overboarding mechanisms are analyzed. The new mechanism to solve these problems is then suggested. For the proposed mechanism, the GA-based MATLAB$^{(R)}$ simulation technique is applied to the proposed mechanism to optimize the link lengths and the actuator lengths. By doing this, the mechanism cannot interfere in the hull's internal environment. Hence, the work range of motion (ROM) is satisfied, and good torque-angle properties are obtaind. The developed technology will be helpful in calculating the maximized output torque of the actuator for the application in practice using a similar type of the proposed mechanism.

Test of the New Health Promotion Model for the Prediction of Female Employees' Health Promotion Behavior at the Manufacturing Plants (제조업 여성근로자의 건강증진행위 예측을 위한 새 건강증진 모형의 검증)

  • Yun, Soon-Nyoung
    • Research in Community and Public Health Nursing
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    • v.12 no.3
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    • pp.557-569
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    • 2001
  • The purpose of the study was to test the Pender's New Health Promotion Model in order to explain and predict female workers' health promotion behavior at manufacturing plants by using latent variable structural equation model. The data were collected from 280 female workers at 8 electronic factories located at Seoul. Kyunggi. and Incheon using a structured questionnaire through interview and self-report. LISREL was used to test the model. The results are as follows: 8 out of 15 paths of the modified one from the hypothetical model of Health Promotion were statistically significant and the total variance was 40%. The relationship between the previous health behavior and the cognitive emotional factor, and the interpersonal factor. and the situational factor each. and the relationship between perceived health status and interpersonal factor, and health promotion behavior each among gamma paths were unidirectional. On the beta paths. the relationship between the interpersonal factor and the cognitive emotional factor was bi-directional: the relationships amongst the interpersonal factor and the commitment to action, and the health promotion behavior were unidirectional. But the commitment to action was not a significant mediating factor to the health promotion behavior. Pender's New Model is considered good to explain and predict the female workers' health promotion behavior. The interpersonal factor should be considered in occupational nursing practice. But the concepts of situation and commitment to action should be further validated and measured.

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Implementation of Digital Laser Welding Cell for Car Side Panel Assembly (차체 사이드 패널 조립을 위한 디지털 레이저용접 셀 구현)

  • Park Hong Seok;Choi Hung Won;Kang Mu Jin
    • Journal of the Korean Society for Precision Engineering
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    • v.22 no.5 s.170
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    • pp.113-120
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    • 2005
  • Because of the turbulent markets and the increasing demand on product quality, the application of new technology to practice is increasingly important. In case of automotive industries, they take interest in laser welding to solve these problems because laser welding has many advantages such as good accessibility, welding quality, fast welding speed and so on. To apply this technology to welding of car body, the data of laser welding are collected through lots of the experiment according to the material, geometry and layer number of welding points. Based on the experiment results and the information of product, i.e. the car side panel, the clustering of stitches for laser welding was carried out and the optimal equipments are selected through the comparison between the requirements of welding and the potential of equipments. Using these results, laser welding cell for the car side panel are configured with the concept of the digital manufacturing, which ensures maximum planning security with visualization and simulation. Finally, the optimal laser welding cell is chosen by the evaluation of alternative cells with assessment criteria.

Detection of $Bacillus$ $cereus$ Group from Raw Rice and Characteristics of Biofilm Formation (쌀로부터 $Bacillus$ $cereus$ Group의 분리와 Biofilm 형성 특성)

  • Kim, Jin-Young;Yoo, Hye-Lim;Lee, Young-Duck;Park, Jong-Hyun
    • The Korean Journal of Food And Nutrition
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    • v.24 no.4
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    • pp.657-663
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    • 2011
  • $Bacillus$ $cereus$ is widely distributed on various foods and is known to cause clinical infections, food poisoning toxin induced diarrhea and vomiting. In this study, $B.$ $cereus$ group detected and analyzed rice, rice bran, and biofilm characterization of $B.$ $cereus$ confirmed. $B.$ $cereus$ was identified in approximately 34.6% of brown rice and 50.0% of rice bran. $B.$ $thuringiensis$ was detected in 3.9% of brown rice and 23% of rice bran, and $B.$ $mycoides$ was isolated from rice bran. The microtiter plate assay detected differences in biofilm-forming ability among $B.$ $cereus$ group isolates. Biofilm of $B.$ $cereus$ seemed to increase the MIC values of antimicrobial agent and antibiotic compounds compared with planktonic cells. Therefore, sufficient attention should be given to good manufacturing practice and good agriculture practice to avoid contamination of $B.$ $cereus$ group raw material including rice.

Evaluation of Good Clinical Practice(GCP) Implementability at the Designated Clinical Trial Hospitals (임상시험 지정병원의 "의약품 임상시험 관리기준(KGCP)" 수행 가능성 평가에 관한 연구)

  • Jang, Sun-Mee;Lee, Eui-Kyung;Park, Byung-Joo;Huh, Soon-Im
    • Quality Improvement in Health Care
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    • v.2 no.1
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    • pp.86-109
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    • 1995
  • Clinical trials of drugs on humans is the final and most important stage in evaluating the safety and efficacy of the drugs. Good Clinical Practice(GCP) standards were announced in 1987 to protect testees' rights as well as to ensure validity of the clinical trial results, but its implementation has been delayed until now. The purpose of this study is to evaluate the preparedness of the designated institutions to abide by GCP standards during clinical trials, and thereby to determine GCP implementability at the institutions. Survey on the status of clinical trials was conducted for the designated 83 clinical trial hospitals. Response rate was 95.2%. Donabedian's quality assessment model was applied as the basic framework for the study. And the relative - weights for the evaluation items were determined by expert's evaluation. Among the designated 83 hospitals, 39 conducted clinical trials to obtain drug manufacturing approval from 1990 to 1994. Only 19 institutions are found to be able to meet the requirements of KGCP. Structure variables - manpower, organization, and facility -, which are the basic elements for GCP, are evaluated as unsatisfied in many hospitals. Institutions which established IRB accounted for 41 or 51.9%, but those who have a protocol evaluation guideline, or Adverse Drug Reaction(ADR) reporting system were only 12 and 21 institutions, respectively. Also, the institutions providing educational programs on conducting clinical trials are few - 20. The study results indicates that the level of conducting KGCP is unsatisfactory. However, more institutions are expected to be able to meet the standards soon because GCP standards does not require so much regulation on facilities, but stress importance on research methodology and human right. At present as the institutions for clinical trials are primarily training hospitals with residency programs, such efforts as education will accelerate the implementability of GCP in Korea. Institutions must build the appropriate infrastructure and government must prepare to strongly enforce KGCP before it can successfully take place.

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Intravenous Toxicity Study of Water-soluble Ginseng Pharmacopuncture in SD Rats

  • Yu, Jun-Sang;Sun, Seung-Ho;Lee, Kwang-Ho;Kwon, Ki-Rok
    • Journal of Pharmacopuncture
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    • v.18 no.4
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    • pp.38-44
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    • 2015
  • Objectives: Radix Ginseng has been used for thousands of years to treat a wide variety of diseases. Radix ginseng has also been used as a traditional medicine for boosting Qi energy and tonifying the spleen and lungs. Traditionally, its effect could be obtained orally. Nowadays, a new method, the injection of herbal medicine, is being used. This study was performed to investigate the single-dose intravenous toxicity of water-soluble ginseng pharmacopuncture (WSGP) in Sprague-Dawley (SD) rats. Methods: All experiments were carried out at Biotoxtech, an institute authorized to perform non-clinical studies under the regulation of Good Laboratory Practice (GLP). At the age of six weeks, 40 SD rats, 20 male rats and 20 female rats, were allocated into one of 4 groups according to the dosages they would receive. The WSGP was prepared in the Korean Pharmacopuncture Institute under the regulation of Korea-Good Manufacturing Practice (K-GMP). Dosages of WSGP were 0.1, 0.5 and 1.0 mL/animal for the experimental groups, and normal saline was administered to the control group. The rat's general conditions and body weights, the results of their hematological and biochemistry tests, and their necropsy and histopathological findings were investigated to identify the toxicological effect of WSGP injected intravenously. The effect was examined for 14 days after the WSGP injection. This study was performed under the approval of the Institutional Animal Ethics Committee of Biotoxtech. Results: No deaths were found in this single-dose toxicity test on the intravenous injection of WSGP, and no significant changes in the rat's general conditions and body weights, the results on their hematological and biochemistry test, and their necropsy findings were observed during the test. The local area of the injection site showed minial change. The lethal dose was assumed to be over 1.0 mL/animal in both sexes. Conclusion: These results indicate that WSGP is safe at dosages up to 1 mL/animal.

Single-dose Toxicity of Water-soluble Ginseng Pharmacopuncture Injected Intramuscularly in Rats

  • Yu, Junsang;Sun, Seungho;Lee, Kwangho;Kwon, Kirok
    • Journal of Pharmacopuncture
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    • v.18 no.2
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    • pp.76-85
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    • 2015
  • Objectives: Radix Ginseng has been traditionally used as an adaptogen that acts on the adrenal cortex and stimulates or relaxes the nervous system to restore emotional and physical balance and to improve well-being in cases of degenerative disease and/or old age. Radix Ginseng has been used for a long time, but the safety of ginseng pharmacopuncture needs testing. This study was done to analyze the single-dose toxicity of water- soluble ginseng pharmacopuncture (GP) intramuscular injections in rats. Methods: All experiments were performed at Biotoxtech, an institution authorized to perform non clinical studies under the regulations of Good Laboratory Practice (GLP). Each group contained 10 Sprague-Dawley rats, 5 males and 5 females. GP was prepared in a sterile room at the Korean Pharmacopuncture Institute under regulations of Good Manufacturing Practice (GMP). GP dosages were 0.1, 0.5 and 1.0 mL for the experimental groups; normal saline was administered to the control group. The animals general condition was examined daily for 14 days, and the rats were weighed on the starting day and at 3, 7 and 14 days after administration of the pharmacopuncture. Hematological and biochemistry tests and autopsies were done to test the toxicological effect of GP after 14 days. This study was performed with approval from the Institutional Animal Ethics Committee of Biotextech. Results: No deaths were found in this single-dose toxicity test of intramuscular injections of GP, and no significant changes in the general conditions, body weights, hematological and biochemistry tests, and autopsies were observed. The local injection site showed no changes. Based on these results, the lethal dose was assumed to be over 1.0 mL/animal in both sexes. Conclusion: These results suggest that GP is relatively safe. Further studies, including a repeated toxicity test, are needed to provide more concrete evidence for the safety of GP.

Single-dose Toxicity of ShinYangHur Herbal Acupuncture

  • Cha, Eunhye;Lee, Jongcheol;Lee, Seongjin;Park, Manyong;Kim, Sungchul
    • Journal of Pharmacopuncture
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    • v.18 no.2
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    • pp.67-75
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    • 2015
  • Objectives: This study was carried out to analyze the single-dose toxicity of ShinYangHur (SYH) herbal acupuncture injected into the muscles of Sprague-Dawley (SD) rats. Methods: The SYH herbal acupuncture was made in a clean room at the Korean Pharmacopuncture Institute (KPI, Korea-Good Manufacturing Practice, K-GMP). After the mixing process with sterile distilled water, the pH was controlled to between 7.0 and 7.5. Then, NaCl was added to make a 0.9% isotonic solution by using sterilized equipment. All experiments were conducted at Biotoxtech, an institution authorized to perform non clinical studies under the regulations of Good Laboratory Practice (GLP). SD rats were chosen for the pilot study. Doses of SYH herbal acupuncture, 0.25, 0.5, and 1.0 mL, were administered to the experimental groups, and a dose of normal saline solution, 1.0 mL, was administered to the control group. This study was conducted under the approval of the Institutional Animal Ethics Committee. Results: No deaths or abnormalities occurred in any of the four groups. No significant changes in weight, hematological parameters or clinical chemistry between the control group and the experimental groups were observed. To check for abnormalities in organs and tissues, we used microscopy was used to examine representative histological sections of each specified organ; the results showed no significant differences in any of the organs or tissues. Conclusion: The above outcomes suggest that treatment with SYH herbal acupuncture is relatively safe. Further studies on this subject are needed to yield more concrete evidence.