• 한국산업보건학회지
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• 제30권1호
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• pp.58-66
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• 2020

Objectives: The objective of this study was to develop formaldehyde samples for quality control (QC) and to test the applicability of proficiency analytical testing in Korea. Methods: We made formaldehyde samples with certified standard solutions (formaldehyde in water or acetonitrile) and 2,4-dinitrophenylhydrazine (2,4-DNPH)-coated silicagel tubes. Four levels of formaldehyde concentration were tested for storage stability at room temperature and at 4℃ over three months. Analytical proficiency testing was performed with four or 36 institutes. Results: Formaldehyde sample tubes were easily made through the injection of standard solutions and the average efficiencies of recovery were 95-101%. The coefficients of variation (CV) of the formaldehyde samples were 1.39-2.55%. The recovery efficiencies fell between 90% and 110% at the concentration range of 1-10 ㎍/sample over three months storage at refrigerated and room temperature. The CVs were less than 5% in the proficiency analytical testing. By adjusted proficient ranges, 64% of the results of the second proficiency analytical testing were acceptable. Conclusions: The formaldehyde samples made by injection on 2,4-DNPH-coated silicagel tubes were stable and applicable for quality control.

• 분석과학
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• 제13권2호
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• pp.229-233
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• 2000

질산성질소와 불소의 저농도 $0.74mgN(NO_3)/l$, $0.58mgF^-/l$ 및 고농도 $2.14mgN(NO_3)/l$, $1.25mgF^-/l$ 표준시료에 대해 정도관리차트에 따라 신뢰도를 검증한 결과 정밀도가 각각 0.010, 0.017, 0.056, 0.019로 우수하게 나타났다. 분석의 숙련도가 다른 A, B, C 세명에 대해 각각의 표준시료로 6회 반복 측정분석한 결과 학력 및 연구경력이 가장 나은 C가 A, B보다 신뢰도가 우수한 측정분석결과를 산출하였다. 3명 모두 평균값이 조제값에 아주 가까운 분석데이타를 산출함으로서 이 표준시료를 외부정도관리 평가용으로 사용하기에 적합하다는 것을 알 수 있었다.

• 분석과학
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• 제22권1호
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• pp.35-43
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• 2009

단순히 완제품만을 평가하는 기존의 방법에서 제조 공정의 보다 깊은 이해와 공정 제어를 통한 품질 확보가 PAT (공정분석기술, process analytical technology)가 지향하고 있는 핵심이다. 생산 상 위험 요소가 많이 발생하는 공정을 제어할 수 있는 목적으로 새로운 실시간 공정 제어 기술을 개발하는 것이 PAT 연구 내용이다. 공정 단계에 대한 이해, 공정에 필요한 여러 가지 변수 및 공정 생산품의 평가 기술은 PAT를 수행하기 위한 기술적 핵심 요소이다. 이에 관련하여 다국적 제약회사의 실제 공정에서의 실시간 품질관리 사례는 상당히 많은 것으로 알려져 있으나, 제조공정 및 분석 기술 자체가 기업 비밀인 경우가 많아 관련 정보는 극히 제한되어 있다. 본 총설을 통하여 실제 제약 산업 현장에서 활용되고 있는 적용사례를 소개하고, 각 제조 공정 및 완제품 실시간 품질 관리를 위한 PAT 연구 사례 및 기술개발 현황에 대하여 언급하고자 한다.

• 동의생리병리학회지
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• 제30권6호
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• pp.397-401
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• 2016

The quality control is a fundamental procedure for the standardization of herbal medicine to guarantee the consistency of efficacy and safety. For a long time, the quality analysis of herbal medicine has been largely dependent on the routine sensory evaluation, such as taste, smell, color, and shape. However, with the recent development of analytical instruments, various scientific approaches have been introduced in this field. On the basis of the theory that the biological activities of herbal medicine are mainly contributed by its chemical compositions, several types of chemical markers have been suggested for the quality evaluation. In addition to the analytical methods for the specific marker compound(s), including analytical marker and active marker, recently, chemical fingerprinting, a method comparing the chromatographic pattern of the whole chemical components, has been developed and widely accepted as a reliable approach for the quality control of herbal medicine. Moreover, in order to exactly understand the relationship between complex compounds and their holistic biological activities in herbal medicine, unique strategies, such as "BECCs (bioactive equivalent combinatorial components)" and "PhytomicsQC" have been established. In this article, we give an overview of the several categories of chemical markers and the recent research trends for the quality evaluation of herbal medicine.

• 한국산업보건학회지
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• 제3권2호
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• pp.194-203
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• 1993

Quality Control programs for industrial hygiene laboratory have successfully been operated since the 1st round was initiated in April 1992. Three rounds have been completed. Overall analytical performance of participants was improved through a subsquent round. The first round had a large variation among analytical results of all participants, 26.34%~504.22% of coefficient of variation. But the variation of analytical performance in the 2nd and 3rd rounds decreased to 40.42%~52.55% and 10.74%~20.98%, respectively. The difference of analytical performance among participants was decreased by operation of subsquent round. By distribution of Running Performance Index (RPI), over 50% of participants belongs to Category 3 in the first round. The average percentage of participants assigned to Category 3 in the 2nd and 3rd round was decreased to 37.2%. A definite analytical performance improvement of participants seems to be obtained. "A" and "B" group have more participants assigned to Category 3 than those of "C" group through the distribution of RPI by group divided to similar participant. By the distribution of RPI all participants, the percent of participant being over 200 RPI in the 1st round was 43%~52%, but decreased to 9%~29% and 9%~27%, in the 2nd and 3rd round, respectively. These results mentioned above indicate that the analytical performance of all participants have been improved by subsquent Quality Control Program although newcomers joined and a few participants droped out. But, there are some participants with poor analytical performance. Industrial Health Research Institute (IHRI) will offer service such as education, communication and visitation to them, and improve quality of their analytical performance in the future.

• 분석과학
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• 제12권4호
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• pp.346-353
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• 1999

For the non-destructive multi-elemental analysis of environmental and biological materials, instrumental neutron activation analysis (INAA) was applied for the determination of toxic and trace elements in a set of three Algae samples provided by the International Atomic Energy Agency (IAEA). The analytical quality control was evaluated by comparing the analytical results of two standard reference materials of the National Institute of Standards and Technology (NIST); Oyster Tissue (SRM 1566a) and Citrus Leaves (SRM 1572). According to given analytical procedure, the concentration of 15-25 elements including spiked elements such as As, Cd, Cr and Hg in Algae samples were determined. To identify and validate these results, a data intercomparison program using more than 35 analytical methods in 150 laboratories was carried out and the estimated statistical data are summarized. Result of INAA is favorable, therefore, it is illustrated that can be applied for routine analysis of essential and toxic elements in algae samples as well as analytical quality assurance.

• 한국산업보건학회지
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• 제19권2호
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• pp.81-87
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• 2009

Final purpose of this study was designed to develop the quality control(QC) sample for proficiency analytical testing of asbestos. This study consisted of two parts; first, development of manufacturing apparatus and sample preparing procedure for asbestos quality control(QC) sample: second, validation of the QC samples made by our developed method as asbestos proficiency analytical testing sample. The main results of the first part research are as followed We developed the apparatus for manufacturing the asbestos QC sample, consisted of filter hold, filter holder manifolder, vacuum system, and vacuum pump. The most proper filter of making the QC samples was a cellulose ester membrane filter with 25 mm diameter, pore size 0.8 um. And we presented the optimal procedure for preparing the asbestos QC sample by using the developed apparatus. We will verify the manufactured asbestos QC samples by this method, and present the validation results to confirm the reliability as a asbestos QC sample in next paper.

• 한국산업보건학회지
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• 제23권3호
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• pp.243-249
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• 2013

Objectives: This study assessed the status of domestic industrial hygiene laboratories using data from on-site investigation for revision of quality control systems in 2012-2013. Methods: The target laboratories were 60 industrial hygiene laboratories chosen by random selection and nationwide distribution which had participated in on-site investigations for revision of quality control systems from March 2012 to August 2013. The investigation was performed on-site following standard quality control procedures. The score between each group was compared using Mann-Whitney and Kruskal-Wallis tests, and the correlation between analytical career, sex, academic major of analyst and score of analytical performance was expressed as Spearman's rank correlation coefficient. Results: The assessment revealed that the items to be improved, in sequence, were effort at staff training (score 65.5), ability to calculate data (score 73.4), establishment of internal quality control guidelines (score 75.7), laboratory facilities (score 77.1), degree of understanding and skill at gas chromatography (score 77.1). Analysis performance showed a positive correlation with career of analyst (r=0.56, p<0.01). Conclusions: The practice of on-site investigation for quality control systems showed the current status of industrial hygiene laboratories in the first trial. There were many laboratories which needed improvement and development of analytical systems. This assessment can provide information for the systematic operation and improvement of facilities at each laboratory. Further practice of this investigation will lead to a proficiency testing and accreditation system for autonomous quality control as is the practice in many countries, rather than mandatory practice by legal regulation.

• 분석과학
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• 제8권4호
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• pp.1079-1087
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• 1995

The quality of human life is directly related to the quality of the environment. To assess environmental quality we must first determine the MCLG(Maximum Contaminant Level Goal), MCL(Maximum Contaminant Level), environmental impact and so on. The MCLG is the concentration at which no known adverse health effects occur. The MCLG is determined by risk assessment identifying which process is hazardous assessing, dose-response, human exposure, and characteristics of risk. With consideration of analytical methods, treatment technology, cost and regulatory impact, the MCL is set as close to the MCLG as possible. In this way, determination of the concentration and national distribution of contaminants is important for assessment of environmental quality The analytical sciences pose potential problems in assessing environmental quality. Continuing improvement in the performance of analytical instruments and operating technique has been lowering the limits of detectability. Contaminant concentration below the detection limit has usually been reported as ND(Not-Detected) and this has often been misunderstood as equivalent to zero. Because of this, more the contaminant concentration in the past was below the detection limit, whereas contaminants can be quantified now even though the contaminant concentration might remain the same or may even have decreased. In addition, environmental sampling has various components due to heterogeneous matrices. These samples are used to overestimate the concentration of the contaminant due to large variability, resulting in excess readings for MCL. In this paper, the significance of the analytical sciences is emphasized in both a conceptual and a technical approach to environmental assessment.

• 분석과학
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• 제9권4호
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• pp.1110-1124
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• 1996