Commenced in January 2007
Frequency: Monthly
Edition: International
Paper Count: 41

Quality Control Related Abstracts

41 Evaluation of Labelling Conditions, Quality Control, and Biodistribution Study of 99mTc- D-Aminolevulinic Acid (5-ALA)

Authors: Kalimullah Khan, Samina Roohi, Mohammad Rafi, Rizwana Zahoor


Labeling of 5-Aminolevulinic acid (5-ALA) with 99 mTc was achieved by using tin chloride dihydrate (Sncl2.2H2O) as reducing agent. Radiochemical purity and labeling efficiency was determined by Whattman paper No.3 and instant thin layer chromatographic strips impregnated with silica gel (ITLC/SG). Labeling efficiency was dependent on many parameters such as amount of ligand, reducing agent, pH, and incubation time. Therefore, optimum conditions for maximum labeling were selected. Stability of 99 mTc- 5-ALA was also checked in fresh human serum. Tissue bio-distribution of 99 mTc-5-ALA was evaluated in Spargue Dawley rats. 5-ALA was 98% labeled with 99 mTc under optimum conditions, i.e. 100µg of 5-ALA, pH: 4, 10µg of Sncl2.2H2O and 30 minutes incubation at room temperature. 99 mTc labelled 5- ALA remained stable for 24 hours in human serum. Bio-distribution study (%ID/gm) in rats revealed that maximum accumulation of 99 mTc-5-ALA was in liver, spleen, stomach and intestine after half hour, 4 hours, and 24 hours. Significant activity in bladder and urine indicated urinary mode of excretion.

Keywords: Radiopharmaceuticals, Quality Control, aminolevulinic acid

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40 Quality Control Assessment of X-Ray Equipment in Hospitals of Katsina State, Nigeria

Authors: Aminu Yakubu Umar


X-ray is the major contributor to the effective dose of both the patient and the personnel. Because of the radiological risks involved, it is usually recommended that dose to patient from X-ray be kept as low as reasonably achievable (ALARA) with adequate image quality. The implementation of quality assurance in diagnostic radiology can help greatly in achieving that, as it is a technique designed to reduce X-ray doses to patients undergoing radiological examination. In this study, quality control was carried out in six hospitals, which involved KVp test, evaluation of total filtration, test for constancy of radiation output, and check for mA linearity. Equipment used include KVp meter, Rad-check meter, aluminum sheets (0.1–1.0 mm) etc. The results of this study indicate that, the age of the X-ray machines in the hospitals ranges from 3-13 years, GHI and GH2 being the oldest and FMC being the newest. In the evaluation of total filtration, the HVL of the X-ray machines in the hospitals varied, ranging from 2.3-5.2 mm. The HVL was found to be highest in AHC (5.2 mm), while it was lowest in GH3 (2.3 mm). All HVL measurements were done at 80 KVp. The variation in voltage accuracy in the hospitals ranges from 0.3%-127.5%. It was only in GH1 that the % variation was below the allowed limit. The test for constancy of radiation output showed that, the coefficient of variation ranges from 0.005–0.550. In GH3, FMC and AHC, the coefficient of linearity were less than the allowed limit, while in GH1, GH2 and GH4 the coefficient of linearity had exceeded the allowed limit. As regard to mA linearity, FMC and AHC had their coefficients of linearity as 0.12 and 0.10 respectively, which were within the accepted limit, while GH1, GH3 and GH4 had their coefficients as 0.16, 0.69 and 0.98 respectively, which exceeded the allowed limit.

Keywords: Radiation, Quality Control, X-ray output, half-value layer, mA linearity, KVp variation

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39 Optimizing and Evaluating Performance Quality Control of the Production Process of Disposable Essentials Using Approach Vague Goal Programming

Authors: Hadi Gholizadeh, Ali Tajdin


To have effective production planning, it is necessary to control the quality of processes. This paper aims at improving the performance of the disposable essentials process using statistical quality control and goal programming in a vague environment. That is expressed uncertainty because there is always a measurement error in the real world. Therefore, in this study, the conditions are examined in a vague environment that is a distance-based environment. The disposable essentials process in Kach Company was studied. Statistical control tools were used to characterize the existing process for four factor responses including the average of disposable glasses’ weights, heights, crater diameters, and volumes. Goal programming was then utilized to find the combination of optimal factors setting in a vague environment which is measured to apply uncertainty of the initial information when some of the parameters of the models are vague; also, the fuzzy regression model is used to predict the responses of the four described factors. Optimization results show that the process capability index values for disposable glasses’ average of weights, heights, crater diameters and volumes were improved. Such increasing the quality of the products and reducing the waste, which will reduce the cost of the finished product, and ultimately will bring customer satisfaction, and this satisfaction, will mean increased sales.

Keywords: Quality Control, Goal Programming, fuzzy regression, vague environment, disposable glasses’ optimization

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38 Integrative-Cyclical Approach to the Study of Quality Control of Resource Saving by the Use of Innovation Factors

Authors: Anatoliy A. Alabugin, Nikolay K. Topuzov, Sergei V. Aliukov


It is well known, that while we do a quantitative evaluation of the quality control of some economic processes (in particular, resource saving) with help innovation factors, there are three groups of problems: high uncertainty of indicators of the quality management, their considerable ambiguity, and high costs to provide a large-scale research. These problems are defined by the use of contradictory objectives of enhancing of the quality control in accordance with innovation factors and preservation of economic stability of the enterprise. The most acutely, such factors are felt in the countries lagging behind developed economies of the world according to criteria of innovativeness and effectiveness of management of the resource saving. In our opinion, the following two methods for reconciling of the above-mentioned objectives and reducing of conflictness of the problems are to solve this task most effectively: 1) the use of paradigms and concepts of evolutionary improvement of quality of resource-saving management in the cycle "from the project of an innovative product (technology) - to its commercialization and update parameters of customer value"; 2) the application of the so-called integrative-cyclical approach which consistent with complexity and type of the concept, to studies allowing to get quantitative assessment of the stages of achieving of the consistency of these objectives (from baseline of imbalance, their compromise to achievement of positive synergies). For implementation, the following mathematical tools are included in the integrative-cyclical approach: index-factor analysis (to identify the most relevant factors); regression analysis of relationship between the quality control and the factors; the use of results of the analysis in the model of fuzzy sets (to adjust the feature space); method of non-parametric statistics (for a decision on the completion or repetition of the cycle in the approach in depending on the focus and the closeness of the connection of indicator ranks of disbalance of purposes). The repetition is performed after partial substitution of technical and technological factors ("hard") by management factors ("soft") in accordance with our proposed methodology. Testing of the proposed approach has shown that in comparison with the world practice there are opportunities to improve the quality of resource-saving management using innovation factors. We believe that the implementation of this promising research, to provide consistent management decisions for reducing the severity of the above-mentioned contradictions and increasing the validity of the choice of resource-development strategies in terms of parameters of quality management and sustainability of enterprise, is perspective. Our existing experience in the field of quality resource-saving management and the achieved level of scientific competence of the authors allow us to hope that the use of the integrative-cyclical approach to the study and evaluation of the resulting and factor indicators will help raise the level of resource-saving characteristics up to the value existing in the developed economies of post-industrial type.

Keywords: Quality Control, Evaluation, integrative-cyclical approach, innovation factors. economic sustainability, innovation cycle of management, disbalance of goals of development

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37 Biosensors as Analytical Tools in Legume Processing

Authors: S. V. Ncube, A. I. O. Jideani, E. T. Gwata


The plight of food insecurity in developing countries has led to renewed interest in underutilized legumes. Their nutritional versatility, desirable functionality, pharmaceutical value and inherent bioactive compounds have drawn the attention of researchers. This has provoked the development of value added products with the aim of commercially exploiting their full potential. However processing of these legumes leads to changes in nutritional composition as affected by processing variables like pH, temperature and pressure. There is therefore a need for process control and quality assurance during production of the value added products. However, conventional methods for microbiological and biochemical identification are labour intensive and time-consuming. Biosensors offer rapid and affordable methods to assure the quality of the products. They may be used to quantify nutrients and anti-nutrients in the products while manipulating and monitoring variables such as pH, temperature, pressure and oxygen that affect the quality of the final product. This review gives an overview of the types of biosensors used in the food industry, their advantages and disadvantages and their possible application in processing of legumes.

Keywords: Biosensors, Quality Control, legume processing, nutritional versatility

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36 Development and Validation of a HPLC Method for Standardization of Methanolic Extract of Hypericum sinaicum Hochst

Authors: Taghreed A. Ibrahim, Atef A. El-Hela, Hala M. El-Hefnawy


The chromatographic profile of methanol extract of Hypericum sinaicum was determined using HPLC-DAD. Apigenin was used as an external standard in the development and validation of the HPLC method. The proposed method is simple, rapid and reliable and can be successfully applied for standardization of Hypericum sinaicum methanol extract.

Keywords: Quality Control, standardization, methanol extract, falvonoids

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35 A Comparison between Empirical and Theoretical OC Curves Related to Acceptance Sampling for Attributes

Authors: Encarnacion Alvarez, Noemı Hidalgo-Rebollo, Juan F. Munoz, Francisco J. Blanco-Encomienda


Many companies use the technique named as acceptance sampling which consists on the inspection and decision making regarding products. According to the results derived from this method, the company takes the decision of acceptance or rejection of a product. The acceptance sampling can be applied to the technology management, since the acceptance sampling can be seen as a tool to improve the design planning, operation and control of technological products. The theoretical operating characteristic (OC) curves are widely used when dealing with acceptance sampling. In this paper, we carry out Monte Carlo simulation studies to compare numerically the empirical OC curves derived from the empirical results to the customary theoretical OC curves. We analyze various possible scenarios in such a way that the differences between the empirical and theoretical curves can be observed under different situations.

Keywords: Quality Control, Monte Carlo Simulation, single-sampling plan, lot

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34 Pharmaceutical Evaluation of Five Different Generic Brands of Prednisolone

Authors: Asma A. Ben Ahmed, Hajer M. Alborawy, Alaa A. Mashina, Pradeep K. Velautham, Abdulmonem Gobassa, Emhemmed Elgallal, Mohamed N. El Attug


Generic medicines are those where patent protection has expired, and which may be produced by manufacturers other than the innovator company. Use of generic medicines has been increasing in recent years, primarily as a cost saving measure in healthcare provision. Generic medicines are typically 20 – 90 % cheaper than originator equivalents. Physicians often continue to prescribe brand-name drugs to their patients even when less expensive pharmacologically equivalent generic drugs are available. Because generics are less expensive than their brand-name counterparts, the cost-savings to the patient is not the only factor that physicians consider when choosing between generic and brand-name drugs. Unfortunately Physicians in general and Libyan Physicians in particular tend to prescribe brand-name drugs, even without evidence of their therapeutic superiority, because neither they nor their insured patients bear these drugs’ increased cost with respect to generic substitutes. This study is to compare the quality of five different prednisolone tablets of the same strength from different companies under different trade names: Julphar, October pharma, Akums, Actavis, Pfizer compared them with pure prednisolone reference (BPCRS).

Keywords: Quality Control, Pharmaceutical Analysis, generic medicines, prednisolone

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33 Generation of Quasi-Measurement Data for On-Line Process Data Analysis

Authors: Hyun-Woo Cho


For ensuring the safety of a manufacturing process one should quickly identify an assignable cause of a fault in an on-line basis. To this end, many statistical techniques including linear and nonlinear methods have been frequently utilized. However, such methods possessed a major problem of small sample size, which is mostly attributed to the characteristics of empirical models used for reference models. This work presents a new method to overcome the insufficiency of measurement data in the monitoring and diagnosis tasks. Some quasi-measurement data are generated from existing data based on the two indices of similarity and importance. The performance of the method is demonstrated using a real data set. The results turn out that the presented methods are able to handle the insufficiency problem successfully. In addition, it is shown to be quite efficient in terms of computational speed and memory usage, and thus on-line implementation of the method is straightforward for monitoring and diagnosis purposes.

Keywords: Data Analysis, Diagnosis, Quality Control, monitoring, process data

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32 Statistical Process Control in Manufacturing, a Case Study on an Iranian Automobile Company

Authors: M. E. Khiav, D. J. Borah, H. T. S. Santos, V. T. Faria


For automobile companies, it has become very important to ensure sound quality in manufacturing and assembling in order to prevent occurrence of defects and to reduce the amount of parts replacements to be done in the service centers during the warranty period. Statistical Process Control (SPC) is widely used as the tool to analyze the quality of such processes and plays a significant role in the improvement of the processes by identifying the patterns and the location of the defects. In this paper, a case study has been conducted on an Iranian automobile company. This paper performs a quality analysis of a particular component called “Internal Bearing for the Back Wheel” of a particular car model, manufactured by the company, based on the 10 million data received from its service centers located all over the country. By creating control charts including X bar–S charts and EWMA charts, it has been observed after the year 2009, the specific component underwent frequent failures and there has been a sharp dip in the average distance covered by the cars till the specific component requires replacement/maintenance. Correlation analysis was performed to find out the reasons that might have affected the quality of the specific component in all the cars produced by the company after the year 2009. Apart from manufacturing issues, some political and environmental factors have been identified to have a potential impact on the quality of the component. A maiden attempt has been made to analyze the quality issues within an Iranian automobile manufacturer; such issues often get neglected in developing countries. The paper also discusses the possibility of political scenario of Iran and the country’s environmental conditions affecting the quality of the end products, which not only strengthens the extant literature but also provides a new direction for future research.

Keywords: Quality Control, Statistical Process Control, capability analysis, car manufacturing, quality tools

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31 [Keynote] Implementation of Quality Control Procedures in Radiotherapy CT Simulator

Authors: B. Petrović, L. Rutonjski, M. Baucal, M. Teodorović, O. Čudić, B. Basarić


Purpose/Objective: Radiotherapy treatment planning requires use of CT simulator, in order to acquire CT images. The overall performance of CT simulator determines the quality of radiotherapy treatment plan, and at the end, the outcome of treatment for every single patient. Therefore, it is strongly advised by international recommendations, to set up a quality control procedures for every machine involved in radiotherapy treatment planning process, including the CT scanner/ simulator. The overall process requires number of tests, which are used on daily, weekly, monthly or yearly basis, depending on the feature tested. Materials/Methods: Two phantoms were used: a dedicated phantom CIRS 062QA, and a QA phantom obtained with the CT simulator. The examined CT simulator was Siemens Somatom Definition as Open, dedicated for radiation therapy treatment planning. The CT simulator has a built in software, which enables fast and simple evaluation of CT QA parameters, using the phantom provided with the CT simulator. On the other hand, recommendations contain additional test, which were done with the CIRS phantom. Also, legislation on ionizing radiation protection requires CT testing in defined periods of time. Taking into account the requirements of law, built in tests of a CT simulator, and international recommendations, the intitutional QC programme for CT imulator is defined, and implemented. Results: The CT simulator parameters evaluated through the study were following: CT number accuracy, field uniformity, complete CT to ED conversion curve, spatial and contrast resolution, image noise, slice thickness, and patient table stability.The following limits are established and implemented: CT number accuracy limits are +/- 5 HU of the value at the comissioning. Field uniformity: +/- 10 HU in selected ROIs. Complete CT to ED curve for each tube voltage must comply with the curve obtained at comissioning, with deviations of not more than 5%. Spatial and contrast resultion tests must comply with the tests obtained at comissioning, otherwise machine requires service. Result of image noise test must fall within the limit of 20% difference of the base value. Slice thickness must meet manufacturer specifications, and patient stability with longitudinal transfer of loaded table must not differ of more than 2mm vertical deviation. Conclusion: The implemented QA tests gave overall basic understanding of CT simulator functionality and its clinical effectiveness in radiation treatment planning. The legal requirement to the clinic is to set up it’s own QA programme, with minimum testing, but it remains user’s decision whether additional testing, as recommended by international organizations, will be implemented, so to improve the overall quality of radiation treatment planning procedure, as the CT image quality used for radiation treatment planning, influences the delineation of a tumor and calculation accuracy of treatment planning system, and finally delivery of radiation treatment to a patient.

Keywords: radiotherapy, Quality Control, CT simulator, QA programme

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30 Virtual Metrology for Copper Clad Laminate Manufacturing

Authors: Misuk Kim, Seokho Kang, Jehyuk Lee, Hyunchang Cho, Sungzoon Cho


In semiconductor manufacturing, virtual metrology (VM) refers to methods to predict properties of a wafer based on machine parameters and sensor data of the production equipment, without performing the (costly) physical measurement of the wafer properties (Wikipedia). Additional benefits include avoidance of human bias and identification of important factors affecting the quality of the process which allow improving the process quality in the future. It is however rare to find VM applied to other areas of manufacturing. In this work, we propose to use VM to copper clad laminate (CCL) manufacturing. CCL is a core element of a printed circuit board (PCB) which is used in smartphones, tablets, digital cameras, and laptop computers. The manufacturing of CCL consists of three processes: Treating, lay-up, and pressing. Treating, the most important process among the three, puts resin on glass cloth, heat up in a drying oven, then produces prepreg for lay-up process. In this process, three important quality factors are inspected: Treated weight (T/W), Minimum Viscosity (M/V), and Gel Time (G/T). They are manually inspected, incurring heavy cost in terms of time and money, which makes it a good candidate for VM application. We developed prediction models of the three quality factors T/W, M/V, and G/T, respectively, with process variables, raw material, and environment variables. The actual process data was obtained from a CCL manufacturer. A variety of variable selection methods and learning algorithms were employed to find the best prediction model. We obtained prediction models of M/V and G/T with a high enough accuracy. They also provided us with information on “important” predictor variables, some of which the process engineers had been already aware and the rest of which they had not. They were quite excited to find new insights that the model revealed and set out to do further analysis on them to gain process control implications. T/W did not turn out to be possible to predict with a reasonable accuracy with given factors. The very fact indicates that the factors currently monitored may not affect T/W, thus an effort has to be made to find other factors which are not currently monitored in order to understand the process better and improve the quality of it. In conclusion, VM application to CCL’s treating process was quite successful. The newly built quality prediction model allowed one to reduce the cost associated with actual metrology as well as reveal some insights on the factors affecting the important quality factors and on the level of our less than perfect understanding of the treating process.

Keywords: Quality Control, predictive modeling, copper clad laminate, virtual metrology

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29 Preparation and Quality Control of a Novel Radiolabeled Complex of 166ho for the Treatment of Somatostatin Receptor Expressing Tumours

Authors: H. Yousefnia, A. Golabi Dezfuli, S. Zolghadri, M. Hosntalab


Peptide receptor radionuclide therapy is nowadays used for the treatment of various abnormalities with somatostatin receptors. In this study, 166Ho-DOTATOC was prepared and the best conditions for its radiolabeling was obtained. For this purpose, a certain of DOTATOC was added to a vial containing 166Ho. various experiments by varying ligand concentration, pH, temperature and time were performed to determine the best conditions. Radiochemical purity of the complex was assessed by instant thin layer chromatography method utilizing 0.9% NaCl as the mobile phase. 166Ho-DOTATOC was prepared with radiochemical purity of higher than 95% at the optimized condition (pH=4, temperature: 95° C, time:30 min). In 0.9% NaCl, free Ho cation was developed at Rf of 0.8 while the complex was remained at the front of the paper.

Keywords: Quality Control, Neuroendocrine, octreotide, Ho-166

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28 Application of Interferometric Techniques for Quality Control Oils Used in the Food Industry

Authors: Andres Piña, Amy Meléndez, Pablo Cano, Tomas Cahuich


The purpose of this project is to propose a quick and environmentally friendly alternative to measure the quality of oils used in food industry. There is evidence that repeated and indiscriminate use of oils in food processing cause physicochemical changes with formation of potentially toxic compounds that can affect the health of consumers and cause organoleptic changes. In order to assess the quality of oils, non-destructive optical techniques such as Interferometry offer a rapid alternative to the use of reagents, using only the interaction of light on the oil. Through this project, we used interferograms of samples of oil placed under different heating conditions to establish the changes in their quality. These interferograms were obtained by means of a Mach-Zehnder Interferometer using a beam of light from a HeNe laser of 10mW at 632.8nm. Each interferogram was captured, analyzed and measured full width at half-maximum (FWHM) using the software from Amcap and ImageJ. The total of FWHMs was organized in three groups. It was observed that the average obtained from each of the FWHMs of group A shows a behavior that is almost linear, therefore it is probable that the exposure time is not relevant when the oil is kept under constant temperature. Group B exhibits a slight exponential model when temperature raises between 373 K and 393 K. Results of the t-Student show a probability of 95% (0.05) of the existence of variation in the molecular composition of both samples. Furthermore, we found a correlation between the Iodine Indexes (Physicochemical Analysis) and the Interferograms (Optical Analysis) of group C. Based on these results, this project highlights the importance of the quality of the oils used in food industry and shows how Interferometry can be a useful tool for this purpose.

Keywords: Quality Control, Food industry, Interferometric, Oils

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27 Framework for Decision Support Tool for Quality Control and Management in Botswana Manufacturing Companies

Authors: Mogale Sabone, Thabiso Ntlole


The pressure from globalization has made manufacturing organizations to move towards three major competitive arenas: quality, cost, and responsiveness. Quality is a universal value and has become a global issue. In order to survive and be able to provide customers with good products, manufacturing organizations’ supporting systems, tools, and structures it uses must grow or evolve. The majority of quality management concepts and strategies that are practiced recently are aimed at detecting and correcting problems which already exist and serve to limit losses. In agile manufacturing environment there is no room for defect and error so it needs a quality management which is proactively directed at problem prevention. This proactive quality management avoids losses by focusing on failure prevention, virtual elimination of the possibility of premature failure, mistake-proofing, and assuring consistently high quality in the definition and design of creation processes. To achieve this, a decision support tool for quality control and management is suggested. Current decision support tools/methods used by most manufacturing companies in Botswana for quality management and control are not integrated, for example they are not consistent since some tests results data is recorded manually only whilst others are recorded electronically. It is only a set of procedures not a tool. These procedures cannot offer interactive decision support. This point brings to light the aim of this research which is to develop a framework which will help manufacturing companies in Botswana build a decision support tool for quality control and management.

Keywords: Manufacturing, Quality management, Quality Control, decision support tool

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26 Knowledge of Quality Assurance and Quality Control in Mammography; A Study among Radiographers of Mammography Settings in Sri Lanka

Authors: H. S. Niroshani, W. M. Ediri Arachchi, R. Tudugala, U. J. M. A. L. Jayasinghe, U. M. U. J. Jayasekara, P. B. Hewavithana


Mammography is used as a screening tool for early diagnosis of breast cancer. It is also useful in refining the diagnosis of breast cancer either by assessment or work up after a suspicious area in the breast has been detected. In order to detect breast cancer accurately and at the earliest possible stage, the image must have an optimum contrast to reveal mass densities and spiculated fibrous structures radiating from them. In addition, the spatial resolution must be adequate to reveal the suffusion of micro calcifications and their shape. The above factors can be optimized by implementing an effective QA programme to enhance the accurate diagnosis of mammographic imaging. Therefore, the radiographer’s knowledge on QA is greatly instrumental in routine mammographic practice. The aim of this study was to assess the radiographer’s knowledge on Quality Assurance and Quality Control programmes in relation to mammographic procedures. A cross-sectional study was carried out among all radiographers working in each mammography setting in Sri Lanka. Pre-tested, anonymous self-administered questionnaires were circulated among the study population and duly filled questionnaires returned within a period of three months were taken into the account. The data on demographical information, knowledge on QA programme and associated QC tests, overall knowledge on QA and QC programmes were obtained. Data analysis was performed using IBM SPSS statistical software (version 20.0). The total response rate was 59.6% and the average knowledge score was 54.15±11.29 SD out of 100. Knowledge was compared on the basis of education level, special training of mammography, and the years of working experience in a mammographic setting of the individuals. Out of 31 subjects, 64.5% (n=20) were graduate radiographers and 35.5% (n=11) were diploma holders while 83.9% (n=26) of radiographers have been specially trained for mammography and 16.1% (n=5) have not been attended for any special training for mammography. It is also noted that 58.1% (n=18) of individuals possessed their experience of less than one year and rest 41.9% (n=13) of them were greater than that. Further, the results found that there is a significant difference (P < 0.05) in the knowledge of QA and overall knowledge on QA and QC programme in the categories of education level and working experience. Also, results imply that there was a significant difference (P < 0.05) in the knowledge of QC test among the groups of trained and non-trained radiographers. This study reveals that education level, working experience and the training obtained particularly in the field of mammography have a significant impact on their knowledge on QA and QC in mammography.

Keywords: Knowledge, Quality Control, Quality assurance, Mammography

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25 Preparation and Quality Control of a New Radiolabelled Complex of Spion

Authors: H. Yousefnia, SJ. Ahmadi, S. Sajadi, S. Zolghadri, A. Bahrami-Samani, M. Bagherzadeh


Nowadays, superparamagnetic iron oxide nanoparticles (SPIONs) as the multitask agents have showed advantageous characteristics. The aim of this study was the preparation and quality control of 153Sm-DTPA-DA-SPION complex. Samarium-153 was produced by neutron irradiation of the enriched 152Sm2O3 in a research reactor for 5 d. For radiolabeling purposes, 8 mg of the ligand was added to the vial containing 153SmCl3 and the mixture was sonicated 30 min, while pH was adjusted to 7-8. The radiochemical purity of the complex was checked by the ITLC method using NH4OH:MeOH:H2O (0.2:2:4) as the mobile phase. This new radiolabeled complex was prepared with a radiochemical purity of higher than 98% in 30 min at the optimized condition. The complex was kept at room temperature and in human serum at 37 °C for 48 h, showed no loss of 153Sm from the complex. Considering all of these features, this new radiolabeled complex can be considered as a good therapeutic agent; however, further studies on its biological behavior are still needed.

Keywords: Quality Control, Preparation, iron nanoparticles

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24 Qualitative Risk Assessment of Rift Valley Fever Vaccine Production

Authors: Mohammed E. Mansour, Tamador M. A. Elhassan, Nahid A. Ibrahim, Awatif A. Ahmed, Manal A. Abdalla


Rift valley fever (RVF) is mosquito-borne disease. RVF is transboundary zoonotic disease. It has socioeconomic and public health importance. This paper describes qualitative risk of the RVF vaccine production. RVF is endemic in the Sudan. It has been reported in Sudan due to abundance of Ades Eqytie. Thus, there is huge effort to control it. Vaccination practices had significant role to control and manage RVF. The risk assessment explains the likelihood of a risk as likely. Thus, insecticides and repellents synergize the effort of the vaccination.

Keywords: Quality Control, Risk Assessment, Qualitative Analysis, rift valley fever vaccine

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23 Development and Validation of a Green Analytical Method for the Analysis of Daptomycin Injectable by Fourier-Transform Infrared Spectroscopy (FTIR)

Authors: Eliane G. Tótoli, Hérida Regina N. Salgado


Daptomycin is an important antimicrobial agent used in clinical practice nowadays, since it is very active against some Gram-positive bacteria that are particularly challenges for the medicine, such as methicillin-resistant Staphylococcus aureus (MRSA) and vancomycin-resistant Enterococci (VRE). The importance of environmental preservation has receiving special attention since last years. Considering the evident need to protect the natural environment and the introduction of strict quality requirements regarding analytical procedures used in pharmaceutical analysis, the industries must seek environmentally friendly alternatives in relation to the analytical methods and other processes that they follow in their routine. In view of these factors, green analytical chemistry is prevalent and encouraged nowadays. In this context, infrared spectroscopy stands out. This is a method that does not use organic solvents and, although it is formally accepted for the identification of individual compounds, also allows the quantitation of substances. Considering that there are few green analytical methods described in literature for the analysis of daptomycin, the aim of this work was the development and validation of a green analytical method for the quantification of this drug in lyophilized powder for injectable solution, by Fourier-transform infrared spectroscopy (FT-IR). Method: Translucent potassium bromide pellets containing predetermined amounts of the drug were prepared and subjected to spectrophotometric analysis in the mid-infrared region. After obtaining the infrared spectrum and with the assistance of the IR Solution software, quantitative analysis was carried out in the spectral region between 1575 and 1700 cm-1, related to a carbonyl band of the daptomycin molecule, and this band had its height analyzed in terms of absorbance. The method was validated according to ICH guidelines regarding linearity, precision (repeatability and intermediate precision), accuracy and robustness. Results and discussion: The method showed to be linear (r = 0.9999), precise (RSD% < 2.0), accurate and robust, over a concentration range from 0.2 to 0.6 mg/pellet. In addition, this technique does not use organic solvents, which is one great advantage over the most common analytical methods. This fact contributes to minimize the generation of organic solvent waste by the industry and thereby reduces the impact of its activities on the environment. Conclusion: The validated method proved to be adequate to quantify daptomycin in lyophilized powder for injectable solution and can be used for its routine analysis in quality control. In addition, the proposed method is environmentally friendly, which is in line with the global trend.

Keywords: Quality Control, Green analytical chemistry, daptomycin, Fourier-transform infrared spectroscopy, spectrometry in IR region

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22 Development and Validation of a Turbidimetric Bioassay to Determine the Potency of Ertapenem Sodium

Authors: Tahisa M. Pedroso, Hérida R. N. Salgado


The microbiological turbidimetric assay allows the determination of potency of the drug, by measuring the turbidity (absorbance), caused by inhibition of microorganisms by ertapenem sodium. Ertapenem sodium (ERTM), a synthetic antimicrobial agent of the class of carbapenems, shows action against Gram-negative, Gram-positive, aerobic and anaerobic microorganisms. Turbidimetric assays are described in the literature for some antibiotics, but this method is not described for ertapenem. The objective of the present study was to develop and validate a simple, sensitive, precise and accurate microbiological assay by turbidimetry to quantify ertapenem sodium injectable as an alternative to the physicochemical methods described in the literature. Several preliminary tests were performed to choose the following parameters: Staphylococcus aureus ATCC 25923, IAL 1851, 8 % of inoculum, BHI culture medium, and aqueous solution of ertapenem sodium. 10.0 mL of sterile BHI culture medium were distributed in 20 tubes. 0.2 mL of solutions (standard and test), were added in tube, respectively S1, S2 and S3, and T1, T2 and T3, 0.8 mL of culture medium inoculated were transferred to each tube, according parallel lines 3 x 3 test. The tubes were incubated in shaker Marconi MA 420 at a temperature of 35.0 °C ± 2.0 °C for 4 hours. After this period, the growth of microorganisms was inhibited by addition of 0.5 mL of 12% formaldehyde solution in each tube. The absorbance was determined in Quimis Q-798DRM spectrophotometer at a wavelength of 530 nm. An analytical curve was constructed to obtain the equation of the line by the least-squares method and the linearity and parallelism was detected by ANOVA. The specificity of the method was proven by comparing the response obtained for the standard and the finished product. The precision was checked by testing the determination of ertapenem sodium in three days. The accuracy was determined by recovery test. The robustness was determined by comparing the results obtained by varying wavelength, brand of culture medium and volume of culture medium in the tubes. Statistical analysis showed that there is no deviation from linearity in the analytical curves of standard and test samples. The correlation coefficients were 0.9996 and 0.9998 for the standard and test samples, respectively. The specificity was confirmed by comparing the absorbance of the reference substance and test samples. The values obtained for intraday, interday and between analyst precision were 1.25%; 0.26%, 0.15% respectively. The amount of ertapenem sodium present in the samples analyzed, 99.87%, is consistent. The accuracy was proven by the recovery test, with value of 98.20%. The parameters varied did not affect the analysis of ertapenem sodium, confirming the robustness of this method. The turbidimetric assay is more versatile, faster and easier to apply than agar diffusion assay. The method is simple, rapid and accurate and can be used in routine analysis of quality control of formulations containing ertapenem sodium.

Keywords: Quality Control, Validation, ertapenem sodium, turbidimetric assay

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21 Quality Approaches for Mass-Produced Fashion: A Study in Malaysian Garment Manufacturing

Authors: N. J. M. Yusof, T. Sabir, J. McLoughlin


Garment manufacturing industry involves sequential processes that are subjected to uncontrollable variations. The industry depends on the skill of labour in handling the varieties of fabrics and accessories, machines, and also a complicated sewing operation. Due to these reasons, garment manufacturers created systems to monitor and control the product’s quality regularly by conducting quality approaches to minimize variation. The aims of this research were to ascertain the quality approaches deployed by Malaysian garment manufacturers in three key areas-quality systems and tools; quality control and types of inspection; sampling procedures chosen for garment inspection. The focus of this research also aimed to distinguish quality approaches used by companies that supplied the finished garments to both domestic and international markets. The feedback from each of company’s representatives was obtained using the online survey, which comprised of five sections and 44 questions on the organizational profile and quality approaches used in the garment industry. The results revealed that almost all companies had established their own mechanism of process control by conducting a series of quality inspection for daily production either it was formally been set up or vice versa. Quality inspection was the predominant quality control activity in the garment manufacturing and the level of complexity of these activities was substantially dictated by the customers. AQL-based sampling was utilized by companies dealing with the export market, whilst almost all the companies that only concentrated on the domestic market were comfortable using their own sampling procedures for garment inspection. This research provides an insight into the implementation of quality approaches that were perceived as important and useful in the garment manufacturing sector, which is truly labour-intensive.

Keywords: Quality Control, Inspection, Sampling, Garment Manufacturing, quality approaches, Acceptance Quality Limit (AQL)

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20 Development and Validation of a Rapid Turbidimetric Assay to Determine the Potency of Cefepime Hydrochloride in Powder Injectable Solution

Authors: Danilo F. Rodrigues, Hérida Regina N. Salgado


Introduction: The emergence of resistant microorganisms to a large number of clinically approved antimicrobials has been increasing, which restrict the options for the treatment of bacterial infections. As a strategy, drugs with high antimicrobial activities are in evidence. Stands out a class of antimicrobial, the cephalosporins, having as fourth generation cefepime (CEF) a semi-synthetic product which has activity against various Gram-positive bacteria (e.g. oxacillin resistant Staphylococcus aureus) and Gram-negative (e.g. Pseudomonas aeruginosa) aerobic. There are few studies in the literature regarding the development of microbiological methodologies for the analysis of this antimicrobial, so researches in this area are highly relevant to optimize the analysis of this drug in the industry and ensure the quality of the marketed product. The development of microbiological methods for the analysis of antimicrobials has gained strength in recent years and has been highlighted in relation to physicochemical methods, especially because they make possible to determine the bioactivity of the drug against a microorganism. In this context, the aim of this work was the development and validation of a microbiological method for quantitative analysis of CEF in powder lyophilized for injectable solution by turbidimetric assay. Method: For performing the method, Staphylococcus aureus ATCC 6538 IAL 2082 was used as the test microorganism and the culture medium chosen was the Casoy broth. The test was performed using temperature control (35.0 °C ± 2.0 °C) and incubated for 4 hours in shaker. The readings of the results were made at a wavelength of 530 nm through a spectrophotometer. The turbidimetric microbiological method was validated by determining the following parameters: linearity, precision (repeatability and intermediate precision), accuracy and robustness, according to ICH guidelines. Results and discussion: Among the parameters evaluated for method validation, the linearity showed results suitable for both statistical analyses as the correlation coefficients (r) that went 0.9990 for CEF reference standard and 0.9997 for CEF sample. The precision presented the following values 1.86% (intraday), 0.84% (interday) and 0.71% (between analyst). The accuracy of the method has been proven through the recovery test where the mean value obtained was 99.92%. The robustness was verified by the parameters changing volume of culture medium, brand of culture medium, incubation time in shaker and wavelength. The potency of CEF present in the samples of lyophilized powder for injectable solution was 102.46%. Conclusion: The turbidimetric microbiological method proposed for quantification of CEF in lyophilized powder for solution for injectable showed being fast, linear, precise, accurate and robust, being in accordance with all the requirements, which can be used in routine analysis of quality control in the pharmaceutical industry as an option for microbiological analysis.

Keywords: Quality Control, Validation, turbidimetric assay, cefepime hydrochloride

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19 Assessing Water Quality Using GIS: The Case of Northern Lebanon Miocene Aquifer

Authors: M. Saba, A. Iaaly, E. Carlier, N. Georges


This research focuses on assessing the ground water quality of Northern Lebanon affected by saline water intrusion. The chemical, physical and microbiological parameters were collected in various seasons spanning over the period of two years. Results were assessed using Geographic Information System (GIS) due to its visual capabilities in presenting the pollution extent in the studied region. Future projections of the excessive pumping were also simulated using GIS in order to assess the extent of the problem of saline intrusion in the near future.

Keywords: Quality Control, GIS, saline water, pumping, drinkable water quality standards

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18 Evaluation of Soil Stiffness and Strength for Quality Control of Compacted Earthwork

Authors: A. Sawangsuriya, T. B. Edil


Microstructure and fabric of soils play an important role on structural properties e.g. stiffness and strength of compacted earthwork. Traditional quality control monitoring based on moisture-density tests neither reflects the variability of soil microstructure nor provides a direct assessment of structural property, which is the ultimate objective of the earthwork quality control. Since stiffness and strength are sensitive to soil microstructure and fabric, any independent test methods that provide simple, rapid, and direct measurement of stiffness and strength are anticipated to provide an effective assessment of compacted earthen materials’ uniformity. In this study, the soil stiffness gauge (SSG) and the dynamic cone penetrometer (DCP) were respectively utilized to measure and monitor the stiffness and strength in companion with traditional moisture-density measurements of various earthen materials used in Thailand road construction projects. The practical earthwork quality control criteria are presented herein in order to assure proper earthwork quality control and uniform structural property of compacted earthworks.

Keywords: Quality Control, moisture content, structural properties, dynamic cone penetrometer, relative compaction, soil stiffness gauge

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17 Quality Management in Spice Paprika Production as a Synergy of Internal and External Quality Measures

Authors: É. Kónya, E. Szabó, I. Bata-Vidács, T. Deák, M. Ottucsák, N. Adányi, A. Székács


Spice paprika is a major spice commodity in the European Union (EU), produced locally and imported from non-EU countries, reported not only for chemical and microbiological contamination, but also for fraud. The effective interaction between producers’ quality management practices and government and EU activities is described on the example of spice paprika production and control in Hungary, a country of leading spice paprika producer and per capita consumer in Europe. To demonstrate the importance of various contamination factors in the Hungarian production and EU trade of spice paprika, several aspects concerning food safety of this commodity are presented. Alerts in the Rapid Alert System for Food and Feed (RASFF) of the EU between 2005 and 2013, as well as Hungarian state inspection results on spice paprika in 2004 are discussed, and quality non-compliance claims regarding spice paprika among EU member states are summarized in by means of network analysis. Quality assurance measures established along the spice paprika production technology chain at the leading Hungarian spice paprika manufacturer, Kalocsai Fűszerpaprika Zrt. are surveyed with main critical control points identified. The structure and operation of the Hungarian state food safety inspection system is described. Concerted performance of the latter two quality management systems illustrates the effective interaction between internal (manufacturer) and external (state) quality control measures.

Keywords: Quality Control, HACCP, spice paprika, RASFF, reporting mechanisms, vulnerable points

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16 Optimal Bayesian Control of the Proportion of Defectives in a Manufacturing Process

Authors: Viliam Makis, Farnoosh Naderkhani, Leila Jafari


In this paper, we present a model and an algorithm for the calculation of the optimal control limit, average cost, sample size, and the sampling interval for an optimal Bayesian chart to control the proportion of defective items produced using a semi-Markov decision process approach. Traditional p-chart has been widely used for controlling the proportion of defectives in various kinds of production processes for many years. It is well known that traditional non-Bayesian charts are not optimal, but very few optimal Bayesian control charts have been developed in the literature, mostly considering finite horizon. The objective of this paper is to develop a fast computational algorithm to obtain the optimal parameters of a Bayesian p-chart. The decision problem is formulated in the partially observable framework and the developed algorithm is illustrated by a numerical example.

Keywords: Quality Control, semi-Markov decision process, Bayesian control chart, partially observable process

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15 Quality Control of 99mTc-Labeled Radiopharmaceuticals Using the Chromatography Strips

Authors: Yasuyuki Takahashi, Akemi Yoshida, Hirotaka Shimada


99mTc-2-methoxy-isobutyl-isonitrile (MIBI) and 99mTcmercaptoacetylgylcylglycyl-glycine (MAG3 ) are heat to 368-372K and are labeled with 99mTc-pertechnetate. Quality control (QC) of 99mTc-labeled radiopharmaceuticals is performed at hospitals, using liquid chromatography, which is difficult to perform in general hospitals. We used chromatography strips to simplify QC and investigated the effects of the test procedures on quality control. In this study is 99mTc- MAG3. Solvent using chloroform + acetone + tetrahydrofuran, and the gamma counter was ARC-380CL. The changed conditions are as follows; heating temperature, resting time after labeled, and expiration year for use: which were 293, 313, 333, 353 and 372K; 15 min (293K and 372K) and 1 hour (293K); and 2011, 2012, 2013, 2014 and 2015 respectively were tested. Measurement time using the gamma counter was one minute. A nuclear medical clinician decided the quality of the preparation in judging the usability of the retest agent. Two people conducted the test procedure twice, in order to compare reproducibility. The percentage of radiochemical purity (% RCP) was approximately 50% under insufficient heat treatment, which improved as the temperature and heating time increased. Moreover, the % RCP improved with time even under low temperatures. Furthermore, there was no deterioration with time after the expiration date. The objective of these tests was to determine soluble 99mTc impurities, including 99mTc-pertechnetate and the hydrolyzed-reduced 99mTc. Therefore, we assumed that insufficient heating and heating to operational errors in the labeling. It is concluded that quality control is a necessary procedure in nuclear medicine to ensure safe scanning. It is suggested that labeling is necessary to identify specifications.

Keywords: Nuclear Medicine, Quality Control, tc-99m labeled radio-pharmaceutical, chromatography strip

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14 Safeguarding Product Quality through Pre-Qualification of Material Manufacturers: A Ship and Offshore Classification Society's Perspective

Authors: Sastry Y. Kandukuri, Isak Andersen


Despite recent advances in the manufacturing sector, quality issues remain a frequent occurrence, and can result in fatal accidents, equipment downtime, and loss of life. Adequate quality is of high importance in high-risk industries such as sea-going vessels and offshore installations in which third party quality assurance and product control play an important essential role in ensuring manufacturing quality of critical components. Classification societies play a vital role in mitigating risk in these industries by making sure that all the stakeholders i.e. manufacturers, builders, and end users are provided with adequate rules and standards that effectively ensures components produced at a high level of quality based on the area of application and risk of its failure. Quality issues have also been linked to the lack of competence or negligence of stakeholders in supply value chain. However, continued actions and regulatory reforms through modernization of rules and requirements has provided additional tools for purchasers and manufacturers to confront these issues. Included among these tools are updated ‘approval of manufacturer class programs’ aimed at developing and implementing a set of standardized manufacturing quality metrics for use by the manufacturer and verified by the classification society. The establishment and collection of manufacturing and testing requirements described in these programs could provide various stakeholders – from industry to vessel owners – with greater insight into the state of quality at a given manufacturing facility, and allow stakeholders to anticipate better and address quality issues while simultaneously reducing unnecessary failures that are costly to the industry. The publication introduces, explains and discusses critical manufacturing and testing requirements set in a leading class society’s approval of manufacturer regime and its rationale and some case studies.

Keywords: Manufacturing, Materials Processing, Quality Control, Materials Testing, classification society

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13 Study of Debonding of Composite Material from a Deforming Concrete Beam Using Infrared Thermography

Authors: Igor Shardakov, Anton Bykov, Alexey Shestakov, Irina Glot


This article focuses on the cycle of experimental studies of the formation of cracks and debondings in the concrete reinforced with carbon fiber. This research was carried out in Perm National Research Polytechnic University. A series of CFRP-strengthened RC beams was tested to investigate the influence of preload and crack repairing factors on CFRP debonding. IRT was applied to detect the early stage of IC debonding during the laboratory bending tests. It was found that for the beams strengthened under load after crack injecting, СFRP debonding strain is 4-65% lower than for the preliminary strengthened beams. The beams strengthened under the load had a relative area of debonding of 2 times higher than preliminary strengthened beams. The СFRP debonding strain is weakly dependent on the strength of the concrete substrate. For beams with a transverse wrapping anchorage in support sections FRP debonding is not a failure mode.

Keywords: Quality Control, Strengthening, Non-Destructive Testing Methods, infrared thermography, IC debonding

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12 Radiochemical Purity of 68Ga-BCA-Peptides: Separation of All 68Ga Species with a Single iTLC Strip

Authors: Anton A. Larenkov, Alesya Ya Maruk


In the present study, highly effective iTLC single strip method for the determination of radiochemical purity (RCP) of 68Ga-BCA-peptides was developed (with no double-developing, changing of eluents or other additional manipulation). In this method iTLC-SG strips and commonly used eluent TFAaq. (3-5 % (v/v)) are used. The method allows determining each of the key radiochemical forms of 68Ga (colloidal, bound, ionic) separately with the peaks separation being no less than 4 σ. Rf = 0.0-0.1 for 68Ga-colloid; Rf = 0.5-0.6 for 68Ga-BCA-peptides; Rf = 0.9-1.0 for ionic 68Ga. The method is simple and fast: For developing length of 75 mm only 4-6 min is required (versus 18-20 min for pharmacopoeial method). The method has been tested on various compounds (including 68Ga-DOTA-TOC, 68Ga-DOTA-TATE, 68Ga-NODAGA-RGD2 etc.). The cross-validation work for every specific form of 68Ga showed good correlation between method developed and control (pharmacopoeial) methods. The method can become convenient and much more informative replacement for pharmacopoeial methods, including HPLC.

Keywords: Radiopharmaceuticals, Quality Control, TLC, DOTA-TATE, radiochemical purity

Procedia PDF Downloads 140