Search results for: pharmaceutical quality control lab

Authors: Stephan Koehler, Thomas Friedli

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Performance measurement has evolved over time from a unidimensional short-term efficiency focused approach into a balanced multidimensional approach. Today, integrated performance measurement frameworks are often used to avoid local optimization and to encourage continuous improvement of an organization. In literature, the multidimensional characteristic of performance measurement is often described by competitive priorities. At the same time, on the highest abstraction level an effectiveness and efficiency dimension of performance measurement can be distinguished. This paper aims at a better understanding of the composition of effectiveness and efficiency and their relation in pharmaceutical quality control labs. The research comprises a lab-specific operationalization of effectiveness and efficiency and examines how the two dimensions are interlinked. The basis for the analysis represents a database of the University of St. Gallen including a divers set of 40 different pharmaceutical quality control labs. The research provides empirical evidence that labs with a high effectiveness also accompany a high efficiency. Lab effectiveness explains 29.5 % of the variance in lab efficiency. In addition, labs with an above median operational excellence performance have a statistically significantly higher lab effectiveness and lab efficiency compared to the below median performing labs.

Keywords: empirical study, operational excellence, performance measurement, pharmaceutical quality control lab

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Authors: Mercy Okezue, Kari Clase, Stephen Byrn, Paddy Shivanand

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Medicines regulatory authorities expect pharmaceutical companies and contract research organizations to seek ways to certify that their laboratory control measurements are reliable. Establishing and maintaining laboratory quality standards are essential in ensuring the accuracy of test results. ‘ISO/IEC 17025:2017’ and ‘WHO Good Practices for Pharmaceutical Quality Control Laboratories (GPPQCL)’ are two quality standards commonly employed in developing laboratory quality systems. A review was conducted on the two standards to elaborate on areas on convergence and divergence. The goal was to understand how differences in each standard's requirements may influence laboratories' choices as to which document is easier to adopt for quality systems. A qualitative review method compared similar items in the two standards while mapping out areas where there were specific differences in the requirements of the two documents. The review also provided a detailed description of the clauses and parts covering management and technical requirements in these laboratory standards. The review showed that both documents share requirements for over ten critical areas covering objectives, infrastructure, management systems, and laboratory processes. There were, however, differences in standard expectations where GPPQCL emphasizes system procedures for planning and future budgets that will ensure continuity. Conversely, ISO 17025 was more focused on the risk management approach to establish laboratory quality systems. Elements in the two documents form common standard requirements to assure the validity of laboratory test results that promote mutual recognition. The ISO standard currently has more global patronage than GPPQCL.

Keywords: ISO/IEC 17025:2017, laboratory standards, quality control, WHO GPPQCL

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Authors: Mary Moner Botros Fanawel

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Many companies use the statistical tool named as statistical quality control, and which can have a high cost for the companies interested on these statistical tools. The evaluation of the quality of products and services is an important topic, but the reduction of the cost of the implantation of the statistical quality control also has important benefits for the companies. For this reason, it is important to implement a economic design for the various steps included into the statistical quality control. In this paper, we describe some relevant aspects related to the economic design of a quality control chart for the proportion of defective items. They are very important because the suggested issues can reduce the cost of implementing a quality control chart for the proportion of defective items. Note that the main purpose of this chart is to evaluate and control the proportion of defective items of a production process.

Keywords: model predictive control, hierarchical control structure, genetic algorithm, water quality with DBPs objectives proportion, type I error, economic plan, distribution function bootstrap control limit, p-value method, out-of-control signals, p-value, quality characteristics

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Authors: Gamalath M. B. P. Abeysekara

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Primary objective of any organization is to enhance the bottom line profit. Strategic procurement is one of the prominent aspects in view of receiving this ultimate objective. Strategic procurement is an activity used in each and every organization in their operations. Pharmaceutical procurement is an especially significant task for any organizations, particularly state sector concerned. The whole pharmaceutical procurement requirement of the country is procured through the State Pharmaceutical Corporation (SPC) of Sri Lanka. They follow Pharmaceutical Procurement Guideline of 2006 as the procurement principle. The main objective of this project is to identify the importance of State Pharmaceutical Corporation supplier selection criteria and critical analysis of pharmaceutical procurement procedure. State Pharmaceutical Corporations applied net price, product quality, past performance, and delivery of suppliers’ as main criteria for the selection suppliers. Data collection for this study was taken place through a questionnaire, given to fifty doctors within the Colombo district attached to five main state hospitals. Data analysis is carried out with mean and standard deviation functions. The ultimate outcomes indicated product quality, net price, and delivery of suppliers’ are the most important criteria behind the selection of suppliers. Critical analysis proved State Pharmaceutical Corporation should focus on net price reduction, improving laboratory testing facilities and effective communication between up and down stream of supply chain.

Keywords: government procurement procedure, pharmaceutical procurement supplier selection criteria, importance of SPC supplier selection criteria

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Authors: O. Ikpotokin

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In any production process, every product is aimed to attain a certain standard, but the presence of assignable cause of variability affects our process, thereby leading to low quality of product. The ability to identify and remove this type of variability reduces its overall effect, thereby improving the quality of the product. In case of a univariate control chart signal, it is easy to detect the problem and give a solution since it is related to a single quality characteristic. However, the problems involved in the use of multivariate control chart are the violation of multivariate normal assumption and the difficulty in identifying the quality characteristic(s) that resulted in the out of control signals. The purpose of this paper is to examine the use of non-parametric control chart (the bootstrap approach) for obtaining control limit to overcome the problem of multivariate distributional assumption and the p-value method for detecting out of control signals. Results from a performance study show that the proposed bootstrap method enables the setting of control limit that can enhance the detection of out of control signals when compared, while the p-value method also enhanced in identifying out of control variables.

Keywords: bootstrap control limit, p-value method, out-of-control signals, p-value, quality characteristics

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Authors: Encarnación Álvarez-Verdejo, Raúl Amor-Pulido, Pablo J. Moya-Fernández, Juan F. Muñoz-Rosas, Francisco J. Blanco-Encomienda

Abstract:

Many companies use the statistical tool named as statistical quality control, and which can have a high cost for the companies interested on these statistical tools. The evaluation of the quality of products and services is an important topic, but the reduction of the cost of the implantation of the statistical quality control also has important benefits for the companies. For this reason, it is important to implement a economic design for the various steps included into the statistical quality control. In this paper, we describe some relevant aspects related to the economic design of a quality control chart for the proportion of defective items. They are very important because the suggested issues can reduce the cost of implementing a quality control chart for the proportion of defective items. Note that the main purpose of this chart is to evaluate and control the proportion of defective items of a production process.

Keywords: proportion, type I error, economic plan, distribution function

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Authors: Mingyu Xie, Mietek Brdys

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The paper develops a non-linear model predictive control (NMPC) of water quality in drinking water distribution systems (DWDS) based on the advanced non-linear quality dynamics model including disinfections by-products (DBPs). A special attention is paid to the analysis of an impact of the flow trajectories prescribed by an upper control level of the recently developed two-time scale architecture of an integrated quality and quantity control in DWDS. The new quality controller is to operate within this architecture in the fast time scale as the lower level quality controller. The controller performance is validated by a comprehensive simulation study based on an example case study DWDS.

Keywords: model predictive control, hierarchical control structure, genetic algorithm, water quality with DBPs objectives

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Authors: S. Bangphan, P. Bangphan, T.Boonkang

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Quality control helps industries in improvements of its product quality and productivity. Statistical Process Control (SPC) is one of the tools to control the quality of products that turning practice in bringing a department of industrial engineering process under control. In this research, the process control of a turning manufactured at workshops machines. The varying measurements have been recorded for a number of samples of a rice polished cylinder obtained from a number of trials with the turning practice. SPC technique has been adopted by the process is finally brought under control and process capability is improved.

Keywords: rice polished cylinder, statistical process control, control charts, process capability

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Authors: Gule Teri

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The effective validation of analytical methods forms a crucial component of pharmaceutical manufacturing. However, traditional validation techniques can occasionally fail to fully account for inherent variations within datasets, which may result in inconsistent outcomes. This deficiency in validation accuracy is particularly noticeable when quantifying low concentrations of active pharmaceutical ingredients (APIs), excipients, or impurities, introducing a risk to the reliability of the results and, subsequently, the safety and effectiveness of the pharmaceutical products. In response to this challenge, we introduce an enhanced, tolerance-based Design of Experiments (DoE) approach for the validation of analytical methods. This approach distinctly measures variability with reference to tolerance or design margins, enhancing the precision and trustworthiness of the results. This method provides a systematic, statistically grounded validation technique that improves the truthfulness of results. It offers an essential tool for industry professionals aiming to guarantee the accuracy of their measurements, particularly for low-concentration components. By incorporating this innovative method, pharmaceutical manufacturers can substantially advance their validation processes, subsequently improving the overall quality and safety of their products. This paper delves deeper into the development, application, and advantages of this tolerance-based DoE approach and demonstrates its effectiveness using High-Performance Liquid Chromatography (HPLC) data for verification. This paper also discusses the potential implications and future applications of this method in enhancing pharmaceutical manufacturing practices and outcomes.

Keywords: tolerance-based design, design of experiments, analytical method validation, quality control, biopharmaceutical manufacturing

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

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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: legume processing, biosensors, quality control, nutritional versatility

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Authors: Yasuyuki Takahashi, Akemi Yoshida, Hirotaka Shimada

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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: quality control, tc-99m labeled radio-pharmaceutical, chromatography strip, nuclear medicine

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Authors: Michael Leontiev, Danil Zhilikov, Dmitry Lobanov, Lenar Klimov, Vyacheslav Chertan, Daniel Bobrov, Vladislav Maslov, Vasilii Vologdin, Ksenia Balabaeva

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Pharmaceutical manufacturing is a complex process, where each stage requires a high level of safety and sterility. Personal Protective Equipment (PPE) is used for this purpose. Despite all the measures of control, the human factor (improper PPE wearing) causes numerous losses to human health and material property. This research proposes a solid computer vision system for ensuring safety in pharmaceutical laboratories. For this, we have tested a wide range of state-of-the-art object detection methods. Composing previously obtained results in this sphere with our own approach to this problem, we have reached a high accuracy ([email protected]) ranging from 0.77 up to 0.98 in detecting all the elements of a common set of PPE used in pharmaceutical laboratories. Our system is a step towards safe medicine production.

Keywords: sterility and safety in pharmaceutical development, personal protective equipment, computer vision, object detection, monitoring in pharmaceutical development, PPE

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Authors: Zhenzhong Yang

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Herbal medicines are important supplements to chemical drugs and usually consist of a complex mixture of constituents. The current quality control strategy of herbal medicines is mainly based on chemical markers, which largely failed to owe to the markers, not reflecting the herbal medicines’ multiple mechanisms of action. Herein, a bioactive chemical markers based strategy was proposed and applied to the quality assessment and control of herbal medicines. This strategy mainly includes the comprehensive chemical characterization of herbal medicines, bioactive chemical markers identification, and related quantitative analysis methods development. As a proof-of-concept, this strategy was applied to a Panax notoginseng derived herbal medicine. The bioactive chemical markers based strategy offers a rational approach for quality assessment and control of herbal medicines.

Keywords: bioactive chemical markers, herbal medicines, quality assessment, quality control

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Authors: Niyom Suwandej

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This research paper investigated the opinions of small and micro community enterprises from Jom Pluak Subdistrict, Bangkhontee District, Samut Songkram Province towards product quality control, and the findings are aimed to disseminate knowledge on quality control for upgrading product standards for small and micro community enterprises. The study employed both qualitative and quantitative methods, in which there were 23 samples in the study. The study was divided into 2 steps which were (1) studying the opinions of the respondents towards the community’s product quality control and upgrading product standards; (2) creating development guidance for product quality control and upgrading product standards for small and micro community enterprise. The demographic findings revealed female respondents as the majority, with most above 50 years of age and married. Most had more than 15 years of working experience. The education level reported by most respondents was primary school or lower followed by secondary school or lower with most respondents was vocational certificate level. Most respondents had the highest level of satisfaction with the existing condition of product quality control knowledge management. Pertaining to opinions on the guidance of knowledge creation for product quality control for small and micro community enterprise, the respondents were willing to apply the knowledge in upgrading their product standards. For the opinions of knowledge creation for product quality control and product standards, the respondents had the highest level of satisfaction. Guidance of knowledge creation for product quality control and product standards for small and micro community enterprises received the highest level of satisfaction from the respondents. Furthermore they had knowledge and comprehension in product quality control and product standards and could apply the knowledge in improving the quality of their production and product standards for small and micro community enterprises.

Keywords: product quality control, product standards, community enterprise, marketing management

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Authors: Clara T. Fatoye, April Betts, Abayomi Odeyemi, Francis A. Fatoye, Isaac O. Odeyemi

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Background: The post-launch stage is the last stage in the development of a pharmaceutical product. It is important to involve patients in the development of pharmaceutical products at the post-launch stage, as patients are the end-users of pharmaceutical products. It is expected that involving them might ensure an effective working relationship among the various stakeholders. However, involving patients in the development of pharmaceutical products comes with its problems. Hence, this study examined how to resolve problems experienced by involving patients in the developments of pharmaceutical products’ at post-launch consisting of Positioning of pharmaceutical products (POPP), detailing of pharmaceutical products (DOPP) and reimbursement and Formulary Submission (R&FS). Methods: A questionnaire was used for the present study. It was administered at the ISPOR Glasgow 2017 to 104 participants, all of which were professionals from Market access (MA) and health economics and outcomes research (HEOR) backgrounds. They were asked how the issues experienced by patients can be resolved. Participants responded under six domains as follows: communication, cost, effectiveness, external factors, Quality of life (QoL) and safety. Thematic analysis was carried out to identify strategies to resolve issues experienced by patients at the post-launch stage. Results: Three (3) factors cut across at POPP, DOPP, and R&FS that is (external factors, communication and QoL). The first resolution method was an external factor that is, the relationship with stakeholders and policymakers. Communication was also identified as a resolution method that can help to resolve problems experienced by patients at the post-launch stage. The third method was QoL as perceived by the patients based on professionals’ opinions. Other strategies that could be used to resolve problems experienced were the effectiveness of pharmaceutical products at the DOPP level and cost at R&FS. Conclusion: The study showed that focusing on external factors, communication, and patients’ QoL are methods for resolving issues experienced by involving patients at the post-launch stage of pharmaceutical product development. Hence, effective working relationships between patients, policymakers and stakeholders may help to resolve problems experienced at the post-launch stage. Healthcare policymakers are to be aware of these findings as they may help them to put appropriate strategies in place to enhance the involvement of patients in pharmaceutical product development at the post-launch stage, thereby improving the health outcomes of the patients.

Keywords: patients, pharmaceutical products, post-launch stage, quality of life, QoL

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Authors: Arvind Dhingra, Ashwani Kumar Sharma

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Power quality is an important parameter for today’s consumers. Various custom power devices are in use to give a proper supply of power quality. Dynamic Voltage Restorer is one such custom power device. DVR is a static VAR device which is used for series compensation. It is a power electronic device that is used to inject a voltage in series and in synchronism to compensate for the sag in voltage. Inductive Loads are a major source of power quality distortion. The induction furnace is one such typical load. A typical induction furnace is used for melting the scrap or iron. At the time of starting the melting process, the power quality is distorted to a large extent especially with the induction of harmonics. DVR is one such approach to mitigate these harmonics. This paper is an attempt to overview the various control strategies being followed for control of power quality by using DVR. An overview of control of harmonics using DVR is also presented.

Keywords: DVR, power quality, harmonics, harmonic mitigation

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

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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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Authors: Mao Ju

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As a capital organizing form, the mixed-ownership reform of state-owned enterprises (SOEs) is an important way to stimulate enterprises’ vitality through reshaping the shareholding structure, enhancing mutual complementation of shareholders’ resources, and improving corporate governance and the quality of internal control. Based on the process of mixed-ownership reform and according to IPO and the change in the key shareholding structure of the listed companies, this paper divides the reform into two stages: primary mixed-ownership reform and secondary mixed-ownership reform (deeper mixed-ownership reform), and uses this as the basis to construct the proxy variable of the mixed-ownership reform of SOEs, research on the relationship between the mixed-ownership reform of SOEs and the quality of internal control. The research reveals that: (1) SOEs completing a secondary mixed-ownership reform can enhance the quality of internal control; (2) In the secondary mixed-ownership reform, the introduction of heterogeneous major shareholders will generate more obvious enhancement in the quality of internal control than the introduction of homogeneous major shareholders. Further research shows that the internal environment and marketization process play a moderating role in the process of the secondary mixed-ownership reform affecting the quality of internal control, that is, a better internal environment or a higher degree of marketization can promote the improvement of the quality of internal control in secondary mixed-ownership reform. The conclusion of the research provides experimental evidence for the expected results of the mixed-ownership reform policy.

Keywords: mixed-ownership reform of state-owned enterprises, secondary mixed-ownership reform, quality of internal control, primary mixed-ownership reform

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Authors: Mogale Sabone, Thabiso Ntlole

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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: decision support tool, manufacturing, quality control, quality management

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Authors: Pankaj Negi

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Nowadays the demand for receiving the high quality electrical energy is being increasing as consumer wants not only reliable but also quality power. Custom power instruments are of the most well-known compensators of power quality in distributed network. This paper present a comprehensive review of compensating custom power devices mainly DSTATCOM (distribution static compensator),DVR (dynamic voltage restorer), and UPQC (unified power quality compensator) and also deals with sliding mode control and its applications to custom power devices. The sliding mode control strategy provides robustness to custom power device and enhances the dynamic response for compensating voltage sag, swell, voltage flicker, and voltage harmonics. The aim of this paper is to provide a broad perspective on the status of compensating devices in electric power distribution system and sliding mode control strategies to researchers and application engineers who are dealing with power quality and stability issues.

Keywords: active power filters(APF), custom power device(CPD), DSTATCOM, DVR, UPQC, sliding mode control (SMC), power quality

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

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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: garment manufacturing, quality approaches, quality control, inspection, Acceptance Quality Limit (AQL), sampling

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Authors: C. Patrascioiu, Cao Minh Ahn

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The paper presents the research evolution in the propylene – propane distillation process, especially for the distillation columns equipped with heat pump. The paper is structured in three parts: separation of the propylene-propane mixture, steady state process modeling, and quality control systems. The first part is dedicated to state of art of the two distillation processes. The second part continues the author’s researches of the steady state process modeling. There has been elaborated a software simulation instrument that may be used to dynamic simulation of the process and to design the quality control systems. The last part presents the research of the control systems, especially for quality control systems.

Keywords: absorption, distillation, heat pump, Unisim design

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Authors: Bernasconi Matteo, Grothkopp Mark, Friedli Thomas

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The objective of this paper is to examine the relationships between technical and social lean bundles as well as operational performance in the context of the pharmaceutical industry. We investigate the direct and mediating effects of the lean bundles total productive maintenance (TPM), total quality management (TQM), Just-In-Time (JIT), and human resource management (HRM) on operational performance. Our analysis relies on 113 manufacturing facilities from the St.Gallen OPEX benchmarking database. The results show that HRM has a positive indirect effect on operational performance mediated by the technical lean bundles.

Keywords: human resource management, operational performance, pharmaceutical industry, technical lean practices

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Authors: A. Sawangsuriya, T. B. Edil

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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: dynamic cone penetrometer, moisture content, quality control, relative compaction, soil stiffness gauge, structural properties

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Authors: Saadan Man, Razidah Othmanjaludin, Madiha Baharuddin

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Nowadays, the pharmaceutical products are produced through the mixing of active and complex ingredient, naturally or synthetically; and involve extensive use of prohibited animal products. This article studies the challenges faced from fiqh perspective in the production of halal pharmaceutical products which frequently contain impure elements or prohibited animal derivatives according to Islamic law. This study is qualitative which adopts library research as well as field research by conducting series of interviews with the several related parties. The gathered data is analyzed from Sharia perspective by using some instruments especially the principle of Maqasid of Sharia. This study shows that the halal status of pharmaceutical products depends on the three basic elements: the sources of the basic ingredient; the processes involved in three phases of production, i.e., before, during and after; and the possible effects of the products. Various fiqh challenges need to be traversed in producing halal pharmaceutical products including the sources of the ingredients, the logistic process, the tools used, and the procedures of productions. Thus, the whole supply chain of production of pharmaceutical products must be well managed in accordance to the halal standard.

Keywords: fiqh, halal pharmaceutical, pharmaceutical products, Malaysia

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Authors: Ambachew Simreteab Gebremedhn

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Context: The paper explores the use of synchronous reference frame theory (SRFT) and instantaneous reactive power theory (IRPT) based control of Unified Power Quality Conditioner (UPQC) for improving power quality in distribution systems. Research Aim: To investigate the performance of different control configurations of UPQC using SRFT and IRPT for mitigating power quality issues in distribution systems. Methodology: The study compares three control techniques (SRFT-IRPT, SRFT-SRFT, IRPT-IRPT) implemented in series and shunt active filters of UPQC. Data is collected under various control algorithms to analyze UPQC performance. Findings: Results indicate the effectiveness of SRFT and IRPT based control techniques in addressing power quality problems such as voltage sags, swells, unbalance, harmonics, and current harmonics in distribution systems. Theoretical Importance: The study provides insights into the application of SRFT and IRPT in improving power quality, specifically in mitigating unbalanced voltage sags, where conventional methods fall short. Data Collection: Data is collected under various control algorithms using simulation in MATLAB Simulink and real-time operation executed with experimental results obtained using RT-LAB. Analysis Procedures: Performance analysis of UPQC under different control algorithms is conducted to evaluate the effectiveness of SRFT and IRPT based control techniques in mitigating power quality issues. Questions Addressed: How do SRFT and IRPT based control techniques compare in improving power quality in distribution systems? What is the impact of using different control configurations on the performance of UPQC? Conclusion: The study demonstrates the efficacy of SRFT and IRPT based control of UPQC in mitigating power quality issues in distribution systems, highlighting their potential for enhancing voltage and current quality.

Keywords: power quality, UPQC, shunt active filter, series active filter, non-linear load, RT-LAB, MATLAB

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Authors: Nerella Srinivas

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This study investigates the role of intellectual property (IP) management in pharmaceutical development, focusing on tools, strategies, and business models for leveraging IP effectively. Using a mixed-methods approach, we conducted case studies and qualitative analyses of IP management frameworks within the pharmaceutical sector. Our methodology included a review of IP tools tailored for pharmaceutical applications, strategic IP models for maximizing competitive advantages, and best practices for organizational efficiency. Findings emphasize the importance of understanding IP law and adopting adaptive strategies, illustrating how IP management can drive industry growth.

Keywords: intellectual property management, pharmaceutical products, IP tools, IP strategies, best practices, business models, innovation

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Authors: Qasim Kriri, Harsh B. Desai

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Water supply and sanitation in Saudi Arabia is portrayed by difficulties and accomplishments. One of the fundamental difficulties is water shortage. With a specific end goal to beat water shortage, significant ventures have been attempted in sea water desalination, water circulation, sewerage, and wastewater treatment. The motivation behind Statistical Process Control (SPC) is to decide whether the execution of a procedure is keeping up an acceptable quality level [AQL]. SPC is an analytical decision-making method. A fundamental apparatus in the SPC is the Control Charts, which follow the inconstancy in the estimations of the item quality attributes. By utilizing the suitable outline, administration can decide whether changes should be made with a specific end goal to keep the procedure in charge. The two most important quality factors in the distilled water which were taken into consideration were pH (Potential of Hydrogen) and TDS (Total Dissolved Solids). There were three stages at which the quality checks were done. The stages were as follows: (1) Water at the source, (2) water after chemical treatment & (3) water which is sent for packing. The upper specification limit, central limit and lower specification limit are taken as per Saudi water standards. The procedure capacity to accomplish the particulars set for the quality attributes of Berain water Factory chose to be focused by the proposed SPC system.

Keywords: acceptable quality level, statistical quality control, control charts, process charts

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Authors: Yohanes Buang, Suwari

Abstract:

Increasing interest of society in use and creation of herbal medicines has encouraged scientists/researchers to establish an ideal method to produce the best quality and quantity of pharmaceutical extracts. To have highest the antioxidative extracts, the method used must be at optimum conditions. Hence, the best method is not only able to provide highest quantity and quality of the isolated pharmaceutical extracts but also it has to be easy to do, simple, fast, and cheap. The characterization of solvents in maceration technique, in present study, involved various variables influencing quantity and quality of the pharmaceutical extracts, such as solvent’s optimum acidity-alkalinity (pH), temperature, concentration, and contact time. The shifting polarity of the solvent by combinations of water with ethanol (70:30) and (50:50) were also performed to completely record the best solvent system in application of maceration technology. Among those three solvents threated within Myrmecodia pendens, as a model of natural product, the results showed that water solvent system with conditions of alkalinity pH, optimum temperature, concentration, and contact time, is the best system to perform the maceration in order to have the highest isolated antioxidative activated extracts. The optimum conditions of the water solvent are at the alkalinity pH 9 up, 30 mg/mL of concentration, 40 min of contact time, 100 °C of temperature, and no ethanol used to replace parts of the water solvent. The present study strongly recommended the best conditions of solvent system to isolate the pharmaceutical extracts of natural products in application of the maceration technology.

Keywords: extracts, herbal medicine, natural product, maceration technique

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Authors: Sameena Malik, Ghosh Prakash, Sandeep Mudliar, Vishal Waindeskar, Atul Vaidya

Abstract:

In this study, the biodegradability enhancement along with COD color and toxicity removal of pharmaceutical effluent by O₃, O₃/Fe²⁺, O₃/nZVI processes has been evaluated. The nZVI particles were synthesized and characterized by XRD and SEM analysis. Kinetic model was reasonably developed to select the ozone doses to be applied based on the ozonation kinetic and mass transfer coefficient values. Nano catalytic ozonation process (O₃/nZVI) effectively enhanced the biodegradability (BI=BOD₅/COD) of pharmaceutical effluent up to 0.63 from 0.18 of control with a COD, color and toxicity removal of 62.3%, 93%, and 75% respectively compared to O₃, O₃/Fe²⁺ pretreatment processes. From the GC-MS analysis, 8 foremost organic compounds were predominantly detected in the pharmaceutical effluent. The disappearance of the corresponding GC-MS spectral peaks during catalyzed ozonation process indicated the degradation of the effluent. The changes in the FTIR spectra confirms the transformation/destruction of the organic compounds present in the effluent to new compounds. Subsequent aerobic biodegradation of pretreated effluent resulted in biodegradation rate enhancement by 5.31, 2.97, and 1.22 times for O₃, O₃/Fe²⁺ and O₃/nZVI processes respectively.

Keywords: iron nanoparticles, pharmaceutical effluent, ozonation, kinetics, mass transfer

Procedia PDF Downloads 271