• 제목/요약/키워드: Manufacturing Process Control

검색결과 1,619건 처리시간 0.029초

Manufacturing Therapeutic Exosomes: from Bench to Industry

  • Ahn, So-Hee;Ryu, Seung-Wook;Choi, Hojun;You, Sangmin;Park, Jun;Choi, Chulhee
    • Molecules and Cells
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    • 제45권5호
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    • pp.284-290
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    • 2022
  • Exosome, a type of nanoparticles also known as small extracellular vesicles are gaining attention as novel therapeutics for various diseases because of their ability to deliver genetic or bioactive molecules to recipient cells. Although many pharmaceutical companies are gradually developing exosome therapeutics, numerous hurdles remain regarding manufacture of clinical-grade exosomes for therapeutic use. In this mini-review, we will discuss the manufacturing challenges of therapeutic exosomes, including cell line development, upstream cell culture, and downstream purification process. In addition, developing proper formulations for exosome storage and, establishing good manufacturing practice facility for producing therapeutic exosomes remains as challenges for developing clinical-grade exosomes. However, owing to the lack of consensus regarding the guidelines for manufacturing therapeutic exosomes, close communication between regulators and companies is required for the successful development of exosome therapeutics. This review shares the challenges and perspectives regarding the manufacture and quality control of clinical grade exosomes.

A Study on Microbiological Hazard Analysis according to the Steaming Process of Various Rice Cakes

  • Kim, Jung-Yun;Park, Da-Hyun;Rha, Young-Ah
    • 한국조리학회지
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    • 제23권6호
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    • pp.20-26
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    • 2017
  • To guarantee the safety of rice cake production, the Hazard Analysis Critical Control Points system was applied to the production process. The purpose of this study was to analyze the microbiological hazards of the manufacture of rice cakes, and establish critical limits in the process of the manufacturing rice cakes. To control the microbiological hazards, the sterilization process was set to a critical limit. The process of manufacturing rice cakes can reduce these microbiological hazards during the steaming process. A microorganism test for each specimen was conducted three times and compared with before and after steaming processes. The finished product was conducted by microbiology experiment and the validity of the steaming process was verified. The results were determined to be capable of reducing the biological element of Critical Control Point via the steaming process. Microbiology such as aerobic plate count, coliform, Escherichia coli(E. coli), Listeria monocytogenes, Enterohemorrhagic E. coli, Salmonella spp., Bacillus cereus, Staphylococcus aureus and Clostridium perfringens was evaluated by the experimental method of Korean Food Standards Codex. Aerobic plate count was reduced by steaming process, and no microorganism were detected. All rice cakes in the finished product were judged to be safe for both the Escherichia coli and general bacteria. In conclusion, it suggested that a HACCP plan was necessary for management standard and systematic approach in the establishment of critical limit, problem resolution, verification method, education, and records management. Based on this study, it is intended to provide a baseline for improving quality control standards and improving hygiene levels for small manufacturers.

2자유도 제어기를 이용한 CNC볼엔드밀링 공정에서 절삭력과 위치의 동시제어 (Simultaneous Control of Cutting Force and Position Using Two Degree-of- Freedom Controller in CNC Ball-end Milling Process)

  • 양호석;심영복;이건복
    • 한국공작기계학회:학술대회논문집
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    • 한국공작기계학회 2002년도 춘계학술대회 논문집
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    • pp.536-542
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    • 2002
  • There are two important variables in machining process control, which are feed and cutting speed. In this work, a two degree-of-freedom controller is designed and implemented to achieve on-line cutting force control and position control based on the modelling of cutting process dynamics which are established through step response test. Two schemes are proposed and implemented. The first is feed control under the constant spindle speed and spindle speed control under the constant feed speed. The second is a simultaneous control of feed and spindle speed. The last performs a position control under the constant cutting force. Those are confirmed to work properly. Especially the latter shows a faster response.

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선삭에서 절삭 속도 제어를 통한 표면 거칠기 향상 (Improvement of Surface Roughness by the Cutting Speed Control for Turning Operation)

  • 최종환
    • 한국기계가공학회지
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    • 제7권2호
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    • pp.23-30
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    • 2008
  • As a basic machining process, turning is a widely used machining process in which a single-point cutting tool removes material from the surface of a rotating material. A common method of evaluating machining performance is to measure the surface roughness. In a turning operation, it is important to select cutting conditions for achieving high cutting performance. As a rule, cutting conditions can be classified into feed rate, depth of cut and insert radius. While cutting process even though cutting conditions are optimized, the average roughness can be deterioration due to wear of the cutting tool edge. In this study, the aim is to maintain the average roughness even though the cutting condition is irregularly changing within the predictable range due to the working environment. First, the surface roughness model influenced by cutting conditions is constructed based on the experimental results in a turning operation, Second, applying the sliding mode control theory to the turning operation model which is composed of the surface roughness model and the motor transfer function, the surface roughness is closed to the desired value. Finally, the effectiveness of this approach is demonstrated through the computer simulation.

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민감도 분석을 이용한 겹치기 필릿용접부 비드형상 예측에 관한 연구 (A Study on the Prediction of Bead Geometry for Lab Joint Fillet Welds Using Sensitivity Analysis)

  • 정재원;김일수;김학형;김인주;방홍인
    • 한국공작기계학회논문집
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    • 제17권6호
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    • pp.49-55
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    • 2008
  • Arc welding process is one of the most important technologies to join metal plates. Robotic welding offers the reduced manufacturing cost sought, but its widespread use demands a means of sensing and correcting for inaccuracies in the part, the fixturing and the robot. A number of problems that need to be addressed in robotic arc welding processes include sensing, joint tracking, and lack of adequate models for process parameter prediction and quality control. Problems with parameter settings and quality control occur frequently in the GMA(Gas Metal Arc) welding process due to the large number of interactive process parameters that must be set and accurately controlled. The objectives of this paper are to realize the mapping characteristics of bead width using a sensitivity analysis and develop the neural network and multiple regression method, and finally select the most accurate model in order to control the weld quality(bead width) for fillet welding. The experimental results show that the proposed neural network estimator can predict bead width with reasonable accuracy, and guarantee the uniform weld quality.

정밀유도무기 품질관리를 위한 공정관리 수행모델에 관한 연구 (A Study on Process Control Modeling for Precision Guided Munitions Quality Control)

  • 김시옥;이창우;차성희
    • 품질경영학회지
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    • 제41권3호
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    • pp.487-494
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    • 2013
  • Purpose: In this study, we propose the precision guided munitions verification methodology using the statistical analysis method has been proposed. and it can be applied to the precision guided munitions quality assurance work. Methods: This modeling is based on Failure Mode and Effects Analysis, Statistical Process Control, Defense Quality Managerment System, Production Readiness Review, Manufacturing Readiness Assesment and so on. Results: The Process Control Modeling that has the following procedures ; searching the critical to quality, statistical analysis by process, verify process. Moreover, the effectiveness of the methodology is verified by applying to the precision guided munitions. Conclusion: To achieve a analysis methods of statistical process control and verify process for precision guided munitions.

LabVIEW를 이용한 TIG 용접 자동 전압 제어 장치 개발 (Development of Automatic Voltage Control Equipment using LabVIEW Software)

  • 송상은;정영철;조영태;정윤교
    • 한국기계가공학회지
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    • 제16권1호
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    • pp.112-117
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    • 2017
  • The arc, generated by Tungsten Inert Gas(TIG) welding, is stable and provides excellent quality of the weld. Since automation is difficult, a lot of work is performed by hand. In addition, to obtain the uniform weld quality is difficult when using a base metal having a nonuniform welding line, or when welding inside a pipe. Generally, TIG welding power has the characteristic of constant-current. The welding voltage is changed in proportion to the arc length. Hence, the automatic voltage control equipment should be applied at the TIG welding system. The automatic voltage control equipment has been designed using LabVIEW software. It consists of a manufactured voltage divider circuit, and jig for moving the torch. The voltage measurements and driving of the motor were performed through the algorithm implementation in LabVIEW. Welding was conducted while increasing the arc length. In this process, it was confirmed that the automatic voltage control equipment kept the arc length constant.

롤다이를 이용한 튜브 축관공정 개발 (Development of Tube End-forming Process using Roll Die)

  • 김영환
    • 한국기계가공학회지
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    • 제10권4호
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    • pp.121-126
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    • 2011
  • An accumulator placed on the refrigerant cycle pipe lines is a part to relax fluctuations of pressure within the pipe lines and stabilize refrigerants flowed into pipe. The accumulator has been mainly manufactured by the process of tube spinning using CNC(Computer Numerical Control) lathe. However, this process has the defects which are low productivity per hour and high cost. For that reason, tube end-forming using roll die is actively being developed, recently. The purpose of this study is to develope the tube end-forming process using roll die in order to manufacture the accumulator for the refrigeration pipe lines. First, the process design of tube end-forming was performed based on specification of product, and then was verified with FE analysis. Also, the effects of friction coefficient and revolution speed of roll die on forming load were investigated. The analytical results were applied in the final process design of tube end-forming. Finally, tube end-forming test was carried out to verify the validity of the FE analysis and the process design.

시멘트 제법의 숙녀화 적용에 대한 접착제 평가와 품질관리에 관한 연구 (A Study on the Evaluation and Quality Control of Adhesives Applicable to the Style of Ladies' Leather Shoe according to the Cementing Process.)

  • 양대용;이상신;이종철
    • 산업경영시스템학회지
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    • 제17권32호
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    • pp.137-144
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    • 1994
  • According to the cementing process, adhesive for dress shoe applicable to the style of ladies' has steadily been developed. In the study on the evaluation, mathematical model is presented. In the study on the quality control, a list of test results from field application and a model of manufacturing process including adhesion process are introduced.

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NC 선반공정에서 주축 전류 모니터링을 통한 구속적응제어 시스템 (Adaptive Control Constraint System through Current Monitoring of Spindle in NC Lathe Process)

  • 신동수
    • 한국공작기계학회:학술대회논문집
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    • 한국공작기계학회 1999년도 추계학술대회 논문집 - 한국공작기계학회
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    • pp.27-33
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    • 1999
  • In order to regulate cutting force at a desired level during NC lathe process, a feedrate override Adaptive Control Constraint system was developed. Nonlinear model of the cutting process was linearized as an adaptive model with a time varing process parameter. Performance of the ACC system was confirmed on the NC lathe equipped with the developed NC system through a large amount of experiment.

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