Статті в журналах: "Good Manufacture Practice"

1

NISHIJIMA, KAZUHIRO. "QA of blood product container ( manufacture ).Quality needed for blood bags and the practice of good manufacture practice (GMP)." Journal of the Japan Society of Blood Transfusion 41, no. 3 (1995): 247–50. http://dx.doi.org/10.3925/jjtc1958.41.247.

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2

Stout, K. J. "Engineering surfaces—a philosophy of manufacture (a proposal for good manufacturing practice)." Proceedings of the Institution of Mechanical Engineers, Part B: Journal of Engineering Manufacture 212, no. 3 (March 1, 1998): 169–74. http://dx.doi.org/10.1243/0954405981515581.

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This paper considers a new approach to controlling the finishing process of engineering surfaces to ensure that their final topography and surface mechanical properties make them suitable for the intended functional purpose. It is proposed that this ‘engineering’ of the final surface is achieved by controlling the final machining or surface working process to impart the required mechanical properties. It is shown in the paper that some surface engineering processes are already employed by industry but that many of these processes are implemented through an empirical understanding of them. The intention of the paper is to lay down a basis for a more rigorous approach to engineering surfaces for their final function.

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3

Burchett, D. H. "Food and drink manufacture: Good manufacturing practice — a guide to its responsible management." Food Control 1, no. 2 (April 1990): 125. http://dx.doi.org/10.1016/0956-7135(90)90098-w.

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Natalia, Hernández Jiménez, Ortuño Montero Natalia, Rojas Salas María Fernanda, Chavarría Rojas Marianela, Vargas Zúñiga Rolando, and Madrigal Redondo German Leonardo. "Analysis and Characterization of Quality Systems in the Natural Medicinal Products Industry in Costa Rica and the World." International Journal of Drug Regulatory Affairs 9, no. 4 (December 26, 2021): 6–19. http://dx.doi.org/10.22270/ijdra.v9i4.494.

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The use of natural products has been a practice carried out by people throughout history to take care of their health and to alleviate a wide variety of ailments. The reasons for the use of natural medicine at this time, with so many advances in pharmacology, are varied, among which are the dissatisfaction of the immediate needs of people to feel better about themselves and the economic factor. It must be considered that not everything natural is good. Therefore, the products manufactured and distributed under the line of Natural Medicinal Products must go through a verification and certification process, ensuring that they contain sufficient information on their composition and effects to avoid the risks that they may bring to those who consume them. This research describes good practices in the manufacture of natural products and shows the establishment of a Quality Management System in the pharmaceutical industry in different countries of the world. Finally, the use of natural products in Costa Rica is detailed, certain aspects to establish a Quality Management System in the country, as well as its importance.

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Lapteva, Natalia, and Juan F. Vera. "Optimization Manufacture of Virus- and Tumor-Specific T Cells." Stem Cells International 2011 (2011): 1–8. http://dx.doi.org/10.4061/2011/434392.

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Althoughex vivoexpanded T cells are currently widely used in pre-clinical and clinical trials, the complexity of manufacture remains a major impediment for broader application. In this review we discuss current protocols for theex vivoexpansion of virus- and tumor-specific T cells and describe our experience in manufacture optimization using a gas-permeable static culture flask (G-Rex). This innovative device has revolutionized the manufacture process by allowing us to increase cell yields while decreasing the frequency of cell manipulation andin vitroculture time. It is now being used in good manufacturing practice (GMP) facilities for clinical cell production in our institution as well as many others in the US and worldwide.

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Stoimenova, Assena H., Bogdan J. Kirilov, Stanislav R. Gueorguiev, Elina S. Petkova-Gueorguieva, and Sava G. Ognianov. "Good Manufacturing Practice for Medicinal Products in Bulgaria: an Analysis of Regulatory Inspection Findings." Folia Medica 62, no. 1 (March 31, 2020): 165–71. http://dx.doi.org/10.3897/folmed.62.e49802.

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Background: The manufacture of medicinal products for human use in the European Economic Area is governed by European Directives and Regulations stipulating the relevant principles and guidelines of Good Manufacturing Practice, describing the minimum standard to be fulfilled in the production processes.   Aim: To present analysis of the deficiencies reported following Good Manufacturing Practice inspections in Bulgaria in two consecutive years (2016, 2017) and to compare them with results from similar inspections reported by other EU member states.   Materials and methods: A retrospective study was carried out by reviewing the complete Good Manufacturing Practice inspection reports of all manufacturers conducted by the Bulgarian Drug Agency in 2016 and 2017, according to relevant requirements and applicable local legislation. The items reviewed were scope of inspection, type of companies, classification of deficiencies – ‘critical’, ‘major’ and ‘other significant deficiencies’, their nature and reference to EU Good Manufacturing Practice.   Results: The analyzed data included 55 inspections, revealing 460 various deficiencies, of which 2 were critical and 102 – major. Twenty inspections were performed in 2016 vs. 35 inspections in 2017. The pattern of deficiencies was similar to the findings of other EU regulatory agencies, showing that equivalent requirements were applied. Our analysis showed that Bulgarian Drug Agency inspectors rarely raised deficiencies related to Computer Systems, Qualification/Validation, Personnel and Qualification of Suppliers unlike other EU regulators agents.   Conclusions: Our analysis of Good Manufacturing Practice inspection findings in 2016 and 2017 showed that the Bulgarian Drug Agency demonstrated its ability to detect non-compliances and take necessary regulatory actions. Quality related issues constitute the main reasons for non-compliances with the requirements. Publishing the results from the inspections performed by the national competent authorities enhances the regulatory transparency that can be useful for industry to improve its Good Manufacturing Practice compliance.

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Zhu, Yao Wu, and Yue Xu. "Application of Computer Technology in the Simulation Process of Machine Design." Applied Mechanics and Materials 481 (December 2013): 217–19. http://dx.doi.org/10.4028/www.scientific.net/amm.481.217.

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Mechanical products are becoming increasingly precise after industrial revolutions. Design is important for the manufacture of those products. Good mechanical design can improve the quality of product, and the efficiency of manufacture. To find the problems in the design and then improve the design, it needed the simulation process after the mechanical design was completed. Computer technologies in simulation process, such as software technology and virtual technology, were deeply studied in this work which combined practice with the concept and characteristics of machine design.

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Huang, Jie, and Hong Jun Liu. "Research and Practice on the End Face Cylindrical Cam NC Machining Technology." Applied Mechanics and Materials 220-223 (November 2012): 406–9. http://dx.doi.org/10.4028/www.scientific.net/amm.220-223.406.

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This paper discussed the CAD / CAM technology of the end face cylindrical cam. The processing of end face cylindrical cam which used in textile machinery was analyzed, and the Processing plan was determined. Three-dimensional modeling and NC programming were done by respectively using PRO/E software and CAXA manufacture engineer software, machining accuracy, fixture and other key technical problems in the end face cylinder cam CAD/CAM process were solved. Acceptable product was processed in common three coordinates milling machine, and ultimately used in enterprises, and achieved good results.

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Rafael, Bence, Nóra Kuruczleki, and József Gál. "The way of the pharmaceutical ingredients to the finished pharmaceutical form." Analecta Technica Szegedinensia 12, no. 2 (December 5, 2018): 24–31. http://dx.doi.org/10.14232/analecta.2018.2.24-31.

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The modern pharmaceutical industry is a strictly controlled area. Both national and international rules apply, but none of these deals with logistical issues arising from the manufacture of the product. Following the path of a drug, it is possible to get acquainted with the problems that arise and their solution. The drug is much more than a common product. The drug is a product of confidence, which is provided with information. It defines its quality as well, to comply with the relevant directives and standards in the manufacture of, and that the enclosed information is sent to the user. This requires the manufacturer, the distributor and the user to comply with it. There is no production without material handling, but GMP (Good Manufacturing Practice) does not yet have a chapter on logistics. References to handling raw materials and finished products can be found in the corresponding GMP chapters, the responsibility of the correct execution are borne by the manufacturer. In this case, the effect of the common sense prevails exponentially, keep the medicine in mind and it has to be done, that no loss, no quality deterioration is not caused by the transport, handling of such loads, storage. It is typical that the raw material and the finished product are going through the entire site during the pharmaceutical manufacture. Starting from the warehouse, it runs through the manufacturing facilities, on the packaging, and some units go to the lab, so that eventually, in medicine form returns to the warehouse, from where it goes further in the supply chain through the pharmacies to the patients. In our study we examine the logistics activity and problems of a small pharmaceutical company and tasks to be solved presented in the light of the theory.

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Gándara, Carolina, Valerie Affleck, and Elizabeth Ann Stoll. "Manufacture of Third-Generation Lentivirus for Preclinical Use, with Process Development Considerations for Translation to Good Manufacturing Practice." Human Gene Therapy Methods 29, no. 1 (February 2018): 1–15. http://dx.doi.org/10.1089/hgtb.2017.098.

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Lai, Huafang, and Qiang Chen. "Bioprocessing of plant-derived virus-like particles of Norwalk virus capsid protein under current Good Manufacture Practice regulations." Plant Cell Reports 31, no. 3 (December 2, 2011): 573–84. http://dx.doi.org/10.1007/s00299-011-1196-6.

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Adam Ismail Ahmed, Ibrahim Adam Osman Algazouly, and Awad Mohammed Babeker. "Assessment of the application of Good Manufacturing Practices (GMP) in some wheat mills in Sudan." International Journal of Life Science Research Archive 3, no. 1 (July 30, 2022): 017–21. http://dx.doi.org/10.53771/ijlsra.2022.3.1.0058.

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The present study was conducted during the period from April to December 2018. The objectives of this work were to assess the application of Good Manufacturing Practice (GMP) in nine wheat mills in Khartoum State and one wheat mills in Elobeid - North Kordofan State. Ready questionnaire prepared by Primus Lab Checklist (2013) was used and data were categorized according to GMP system. Concerning the first part of general GMP, the result revealed that two wheat mills in Khartoum state adopted the general GMP system whereas eight wheat mills were not adopted it. Regarding pest control requirements the mills scores ranged (48-87) out of 95 degree, for storage area and packaging material the score was (33-55) out of 55 degree, only one wheat mills in Khartoum state scored full degree. Concerning the operational practice requirement, all mills scores ranged (80-133) out of 144 degree and for the employee practice requirement they gained (9-45) out of 64 degree. In case of the equipment, the score was (32-50) for all mills and (40%) of wheat mills in Khartoum scored full degree whereas for the equipment cleaning requirement they acquired (26-60) and (20%) of them that belong to Khartoum had full degree, for general cleaning they recorded (32-73) out of 83 degree and for building and ground requirement they obtained (77-102) out of 106 degree. The total degree of Good Manufacture Practice (GMP) varied from 346 to 641 compared to 642 degree. The result showed that the mean total score of Good Manufacturing Practices in all expellers in this study was 693.3 points (69.33%) the highest score recorded 855 points (85.5%) in M8 and the lowest score obtained 555 points (55.5%) in M2, M6 and M10, respectively out of 1000 points. These findings indicated that the M8 plant was categorized as very good, while M9 was standard, but the rests of wheat mills studied in present investigation were categorized as unsatisfactory.

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Liu, Joe, Brendan Cook, and Shaun Roux. "The challenges in commercialisation of Probiotic API manufacturing." Microbiology Australia 41, no. 2 (2020): 82. http://dx.doi.org/10.1071/ma20021.

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The concept of probiotics is well known and has developed into a high value commodity in recent times. Despite the ever-expanding number of probiotic products on our pharmacy, health food and supermarket shelves, the probiotic culture active ingredient has always been imported until now. In 2019, Probiotics Australia Pty Ltd opened Australia’s first and only Therapeutic Goods Administration/current Good Manufacturing Practice (TGA/cGMP) certified facility dedicated to the manufacture of probiotic active ingredients. This article outlines the significant export demand for Australian-made health products and the lengths to which Probiotics Australia have gone to create a facility to meet needs of the probiotics research, commercialisation and consumer market today and into the future.

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Lai, Huafang, and Qiang Chen. "Erratum to: Bioprocessing of plant-derived virus-like particles of Norwalk virus capsid protein under current Good Manufacture Practice regulations." Plant Cell Reports 32, no. 10 (July 27, 2013): 1659. http://dx.doi.org/10.1007/s00299-013-1484-4.

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Ali, Muhammad, Ifan Eka Saputra, Adillida Adillida, Sri Sofyani, and Iskandar Z. Lubis. "Knowledge, attitude, and practice of working and non-working mothers concerning immunization of underfive children." Paediatrica Indonesiana 44, no. 3 (October 10, 2016): 101. http://dx.doi.org/10.14238/pi44.3.2004.101-5.

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Objective To compare the knowledge and attitude of working moth-ers (WM) and non-working mothers (NWM) concerning immuniza-tion in children.Methods A cross sectional study was conducted on February, 18-23, 2002 at PT. Olagafood Industri, a noodle manufacture in TanjungMorawa, Medan. Subjects were female workers and non-workingwives of male workers who had under-five-year children. Motherswere interviewed using a questionnaire. Sample size for each groupwas 38. Degree of knowledge, attitude, and practice concerningimmunization were classified into good, insufficient, and bad.Results Mothers’ age, educational level, and children’s age werecomparable between the two groups. Ten WM and 8 NWM hadgood knowledge concerning immunization, which did not differ sig-nificantly (p>0.05). Good attitude toward immunization was foundin 25 WM and 12 NWM; it was a statistically significant difference(p<0.05). The practice of immunization showed similar result asthe attitude. The age of mothers had a significant relationship withthe degree of knowledge and practice, but not with attitude.Conclusion Degree of knowledge about immunization betweenWM and NWM are comparable, but differences exist in their atti-tude and performance

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Popa, Dorinel, and Cristin-Olimpiu Morariu. "Modern Technologies for Micro-drilling of the Fuel Injector Nozzle used in Motor Vehicles - A Review of the Literature." MATEC Web of Conferences 343 (2021): 03007. http://dx.doi.org/10.1051/matecconf/202134303007.

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To cope with the pollution norms and an improvement of the combustion of the internal combustion engines, high-quality holes with diameters smaller than 145 µm are needed for the manufacture of fuel injection nozzles. The current practice of using drilling by electro-discharge machining of fuel injection nozzles is limited in terms of the size of the hole it can efficiently produce and the time required for drilling. In addition, the cost of the tool is high. This paper presents an investigation into a sequential laser and electro-discharge micro-drilling technique for the manufacture of fuel injection nozzles. A pilot hole drilled with a laser is removed by electrodischarge. It was found that this hybrid process eliminated the problems of reformed and heat-affected areas usually associated with the laser drilling process. The new process has allowed a reduction in total drilling time compared to standard electro-discharge machining drilling, as less material is removed from the electro-discharge machining. The quality of the holes is as good as direct electro-discharge machining drilling. This technique has allowed valuable cost savings and increased production capacity for the manufacture of the fuel injector nozzle.

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Burcham, Christopher L., Alastair J. Florence, and Martin D. Johnson. "Continuous Manufacturing in Pharmaceutical Process Development and Manufacturing." Annual Review of Chemical and Biomolecular Engineering 9, no. 1 (June 7, 2018): 253–81. http://dx.doi.org/10.1146/annurev-chembioeng-060817-084355.

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The pharmaceutical industry has found new applications for the use of continuous processing for the manufacture of new therapies currently in development. The transformation has been encouraged by regulatory bodies as well as driven by cost reduction, decreased development cycles, access to new chemistries not practical in batch, improved safety, flexible manufacturing platforms, and improved product quality assurance. The transformation from batch to continuous manufacturing processing is the focus of this review. The review is limited to small, chemically synthesized organic molecules and encompasses the manufacture of both active pharmaceutical ingredients (APIs) and the subsequent drug product. Continuous drug product is currently used in approved processes. A few examples of production of APIs under current good manufacturing practice conditions using continuous processing steps have been published in the past five years, but they are lagging behind continuous drug product with respect to regulatory filings.

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Cui, Feng Lu, Wen Xin Shi, Xiao Bing Li, and Chun Quan Hao. "Multi-Purpose Hydrocyclone Research and Application." Advanced Materials Research 813 (September 2013): 210–13. http://dx.doi.org/10.4028/www.scientific.net/amr.813.210.

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Hydrocyclone is widely used in grading size in 3 ~ 250 μ m classification or separation assignments and grading size less than 15 μ m enrichment or clarification assignments. Now almost having no concentrator don't use hydraulic cyclone. Small diameter hydrocyclone of diameterΦ10 mm can classify ultrafine pulverized coal . So the application of two phase fluid theory and cyclone technology base on the principles of design,Design and manufacture a variety of small diameter hydrocyclone. After practice has proved. Sorting coal superfine particle effect is good. and can be used for sorting other mineral.

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Balasingam, Shobana, Sarah Meillon, Cecilia Chui, Alex Mann, Carine La, Charlotte L. Weller, Deborah F. King, and Emma Smith. "Human infection studies: Key considerations for challenge agent development and production." Wellcome Open Research 7 (April 22, 2022): 140. http://dx.doi.org/10.12688/wellcomeopenres.17869.1.

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Human infection (or challenge) studies involve the intentional administration of a pathogen (challenge agent) to volunteers. The selection, isolation, development and production of the challenge agent is one of the first steps in developing a challenge study and critical for minimising the risk to volunteers. Regulatory oversight for this production differs globally. Manufacturing agents within a Good Manufacturing Practice (GMP) facility reduces the risk of the manufacturing process by including processes such as confirming the identity of the challenge agent and ascertaining that it’s pure and free from impurities. However, in some cases it’s not possible or feasible to manufacture to GMP standards, for example where the challenge agent requires an intermediate vector for growth. There is lack of clear guidance on what the minimum requirements for high-quality safe manufacture outside of GMP facilities should be and here we describe the development of a considerations document for the selection and production of challenge agents to meet this need.

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Kropp, Martina, Nina Harmening, Thais Bascuas, Sandra Johnen, Eline De Clerck, Verónica Fernández, Mattia Ronchetti, et al. "GMP-Grade Manufacturing and Quality Control of a Non-Virally Engineered Advanced Therapy Medicinal Product for Personalized Treatment of Age-Related Macular Degeneration." Biomedicines 10, no. 11 (November 1, 2022): 2777. http://dx.doi.org/10.3390/biomedicines10112777.

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The introduction of new therapeutics requires validation of Good Manufacturing Practice (GMP)-grade manufacturing including suitable quality controls. This is challenging for Advanced Therapy Medicinal Products (ATMP) with personalized batches. We have developed a person-alized, cell-based gene therapy to treat age-related macular degeneration and established a vali-dation strategy of the GMP-grade manufacture for the ATMP; manufacturing and quality control were challenging due to a low cell number, batch-to-batch variability and short production duration. Instead of patient iris pigment epithelial cells, human donor tissue was used to produce the transfected cell product (“tIPE”). We implemented an extended validation of 104 tIPE productions. Procedure, operators and devices have been validated and qualified by determining cell number, viability, extracellular DNA, sterility, duration, temperature and volume. Transfected autologous cells were transplanted to rabbits verifying feasibility of the treatment. A container has been engineered to ensure a safe transport from the production to the surgery site. Criteria for successful validation and qualification were based on tIPE’s Critical Quality Attributes and Process Parameters, its manufacture and release criteria. The validated process and qualified operators are essential to bring the ATMP into clinic and offer a general strategy for the transfer to other manufacture centers and personalized ATMPs.

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Novák, Vítězslav, Jiri Zach, and Martina Reif. "Using Waste PUR Granules as an Alternative to Integrated Thermal Insulation in Ceramic Blocks." Key Engineering Materials 714 (September 2016): 128–33. http://dx.doi.org/10.4028/www.scientific.net/kem.714.128.

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The paper deals with the use of waste granular PUR, which currently does not have a wide application in the building practice. Waste granular PUR is formed during the manufacture and moulding of thermal insulation elements made of PUR foam. Good thermal insulation properties can be expected in this waste granular PUR, approaching those of the commonly used thermal insulation today (mineral wool, polystyrene). The paper deals with a thermal insulating mixture of granular PUR with a silicate binder. This newly designed thermal insulation mixture was tested as an alternative integrated thermal insulation in ceramic masonry blocks.

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Talip, Zeynep, Chiara Favaretto, Susanne Geistlich, and Nicholas P. van der Meulen. "A Step-by-Step Guide for the Novel Radiometal Production for Medical Applications: Case Studies with 68Ga, 44Sc, 177Lu and 161Tb." Molecules 25, no. 4 (February 20, 2020): 966. http://dx.doi.org/10.3390/molecules25040966.

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The production of novel radionuclides is the first step towards the development of new effective radiopharmaceuticals, and the quality thereof directly affects the preclinical and clinical phases. In this review, novel radiometal production for medical applications is briefly elucidated. The production status of the imaging nuclide 44Sc and the therapeutic β--emitter nuclide 161Tb are compared to their more established counterparts, 68Ga and 177Lu according to their targetry, irradiation process, radiochemistry, and quality control aspects. The detailed discussion of these significant issues will help towards the future introduction of these promising radionuclides into drug manufacture for clinical application under Good Manufacturing Practice (GMP).

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Hu, Shu E., Wei Hua Sun, Xiao Dong Liu, Dong Hua Hou, Rui Zhou, Feng Qiang Xia, Yu Zhen Liu, and Guo Dong Wang. "Development and Application Practice of a 550MPa Grade Steel Plate in Purpose to Reduce Weight for Heavy Machinery Manufacture." Materials Science Forum 773-774 (November 2013): 518–24. http://dx.doi.org/10.4028/www.scientific.net/msf.773-774.518.

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To save energy, the heavy machinery industries are encountering the challenge of reducing the equipment weight. The paper introduced a 550 MPa grade steel plate to replace the traditional 345 MPa grade steel for heavy machinery manufacturing. The niobium and vanadium micro-alloyed steel plate is characterized as bainite microstructure with high toughness, improved welding performance, and good fatigue resistance. A comparison between the present 550 MPa grade steel plate and a Ni, Mo, Cu bainite steel was studied. The developed steel plate shows competitiveness for a high performance and low cost. The 15% of weight reduction is achieved in a 50 ton digger at a typical engineering machinery plant.

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Semeniuk, Serhii, and Vadym Povodzinskiy. "Risk assessment in development of technical requirements for designing fermentation equipment in accordance with requirements of good manufacturing practice." Technology audit and production reserves 3, no. 2(59) (June 30, 2021): 46–50. http://dx.doi.org/10.15587/2706-5448.2021.233536.

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The object of research is the risks arising at the stage of cultivation of biological agents in fermentation equipment. The starting point of the life cycle of equipment, including fermenters, is the terms of reference, which defines all the necessary requirements that must be taken into account in the design, manufacture, installation and qualification. One of the most important and important stages of the equipment life cycle is the formation of a holistic and complete technical specification, which would allow taking into account all critical process parameters already at the stage of developing the design of the fermenter in accordance with the requirements of good manufacturing practice. It is important to note that the regulatory documents of the pharmaceutical industry (good manufacturing practices, good engineering practices, etc.) do not form specific requirements for equipment and processes, but only define general approaches to ensuring the quality system. The study used the principles of risk management, which are advisable to use throughout the entire life cycle of the equipment. The analysis of the stages of sanitary preparation (washing, disinfection and rinsing), sterilization of the fermenter and the cultivation process made it possible to determine the risks arising at the corresponding stages of production and ways to solve them. The approach to the analysis of critical parameters proposed in this work can be used to improve the development of technical specifications for a fermenter. Thanks to this, at the initial stages, a comprehensive approach to risk management is provided, which in turn will prevent the negative impact of external factors on the final product. Another aspect of using the research results is the possibility of forming fermenter validation protocols. The results obtained in this work can also be used in the development and scaling of the cultivation process for the production of active pharmaceutical ingredients in biopharmaceutical production.

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Oke, Sunday Ayoola, Ayokunle Bamigbaiye, and Oluwafemi Isaac Oyedokun. "A MATHEMATICAL MODEL FOR EVALUATING ACCELERATED WEAR DUE TO INEFFICIENT MAINTENANCE." TRANSPORT 21, no. 2 (June 30, 2006): 105–11. http://dx.doi.org/10.3846/16484142.2006.9638050.

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This paper examines accelerated wear due to inefficient maintenance practice in the engineering organization, with a special focus on plant machinery. It considers some important parameters, mathematical relations and how to reduce the effect of poor maintenance practices on plant machinery. Mathematical tools of calculus, series, statistics, and variation were utilized in the development of the model. The result shows that poor maintenance practices increase accelerated wear in plant machinery while good maintenance is aided by planned maintenance, well‐stocked inventory of spare parts, good production procedures, extended plant life, etc. This work is limited in scope since it considers a limited number of parameters as measures of wear. The paper is valuable to the maintenance manager and practitioners who intend to produce/manufacture and at the same time minimize the accelerated wear in production machinery by close monitoring, and using the model as a tool. The work is of immense benefits to managers in process industries, particularly in oil and gas exploration activities. The work is new, presenting a simple approach for easy adaptation in the industry. The approach utilized is not yet documented in the maintenance engineering literature. Thus, a new area of research is opened up for research explorations for the members of the maintenance engineering community

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Berisa-Prado, Silvia, Natalia Vázquez, Manuel Chacón, Mairobi Persinal-Medina, Sergio Alonso-Alonso, Begoña Baamonde, José F. Alfonso, Luis Fernández-Vega-Cueto, Jesús Merayo-Lloves, and Álvaro Meana. "Mini Cleanroom for the Manufacture of Advanced Therapy Medicinal Products (ATMP): Bioengineered Corneal Epithelium." Pharmaceutics 13, no. 8 (August 17, 2021): 1282. http://dx.doi.org/10.3390/pharmaceutics13081282.

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Among several requirements for the manufacture of Advanced Therapy Medicinal Products (ATMP) are: following the guidelines of a pharmaceutical quality system, complying with Good Manufacturing Practice (GMP) and access to a cleanroom fulfilling strict environmental conditions (Class A work area and Class B environment). This makes ATMP expensive. Moreover, the production of many of these therapeutic products may also be unprofitable, as in most cases their use is limited to a few patients and to a single batch per manufacturing unit. To reduce costs, ATMP may be produced in a scaled-down system isolated from the external environment (isolator), allowing for placement of this facility in a Class D environment, which is much more permissive and less costly. In this work, we confirm that it is possible to manufacture bioengineered corneal epithelium inside an isolator while fulfilling all the safety assurance standards at an affordable cost for patients. This small-scale ultra-clean working environment complies with GMP guidelines and could be a solution for the high costs associated with conventional cleanroom ATMP production.

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Williams, David J., Robert J. Thomas, Paul C. Hourd, Amit Chandra, Elizabeth Ratcliffe, Yang Liu, Erin A. Rayment, and J. Richard Archer. "Precision manufacturing for clinical-quality regenerative medicines." Philosophical Transactions of the Royal Society A: Mathematical, Physical and Engineering Sciences 370, no. 1973 (August 28, 2012): 3924–49. http://dx.doi.org/10.1098/rsta.2011.0049.

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Innovations in engineering applied to healthcare make a significant difference to people's lives. Market growth is guaranteed by demographics. Regulation and requirements for good manufacturing practice—extreme levels of repeatability and reliability—demand high-precision process and measurement solutions. Emerging technologies using living biological materials add complexity. This paper presents some results of work demonstrating the precision automated manufacture of living materials, particularly the expansion of populations of human stem cells for therapeutic use as regenerative medicines. The paper also describes quality engineering techniques for precision process design and improvement, and identifies the requirements for manufacturing technology and measurement systems evolution for such therapies.

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MOBERG, LLOYD. "Good Manufacturing Practices for Refrigerated Foods." Journal of Food Protection 52, no. 5 (May 1, 1989): 363–67. http://dx.doi.org/10.4315/0362-028x-52.5.363.

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Good Manufacturing Practices are essential for the manufacture and distribution of refrigerated foods that are safe from microbiological hazards. A refrigerated foods manufacturer should use a comprehensive program that evaluates, identifies, and then controls potential hazards at every step in the development and manufacturing environment. A set of GMPs for refrigerated foods is presented that reviews food safety practices in ingredient receipt and handling, product development, processing, packaging, storage and distribution, and record keeping.

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Maziya, Fina Binazir, and Azham Umar Abidin. "Peningkatan Pengetahuan Keselamatan Kesehatan Kerja (K3) dan Pengelolaan Limbah Padat di Home Industry Manufacture." Jurnal Teknik Lingkungan 28, no. 1 (April 30, 2022): 1–10. http://dx.doi.org/10.5614/j.tl.2022.28.1.1.

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Abstract. Home industry workers in manufacturing have low to high occupational risks in their work environment. This community service activity aims to increase workers' knowledge of the hazards in the work environment and increase awareness of the use of personal protective equipment in the workplace. The activity was carried out using the grafting method, namely observation, education, and evaluation of the activity's stages. Based on the assessment results, this method is quite good in making workers master and understand basic knowledge in the field of occupational safety and health, as well as handling solid waste from daily industrial activities. Workers can apply the practice of using Personal Protective Equipment correctly and managing the waste generated. Increased knowledge of Occupational Safety & Health (OSH) and waste management in workers can reduce near misses, incidents or even minimize work accidents in the workplace. Keywords: occupational health and safety, home industry, solid waste, knowledge of occupational health and safety, PPE, work accident

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30

Wiraguna, Andrian, Fitra Syawal Harahap, Novilda Elizabeth Mustamu, and Ika Ayu Putri Septyani. "Pemanfaatan Limbah Kotoran Sapi Sebagai Bahan Utama Pembuatan Pupuk Organik untuk Mengurangi Penggunaan Pupuk Kimia di Desa Tebing Tinggi Pangkatan." Jurnal Pengabdian Magister Pendidikan IPA 5, no. 2 (April 6, 2022): 1–5. http://dx.doi.org/10.29303/jpmpi.v5i2.1463.

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Анотація:

The population of cattle in the village of cliffs of high rank has enormous potential. This capacity is very good if used in the manufacture of organic fertilizer because in general cow dung waste has not been processed and utilized properly by the people of the village of cliffs of high rank. Agricultural activities of the high-ranking cliff village community which continuously result in the use of chemical fertilizers continue to increase, thus the use of organic fertilizers is an alternative in reducing community dependence in using chemical fertilizers in agriculture. The objectives of this community service are, 1) to carry out socialization and training to the community, 2) to understand more about the manufacturing procedure, the tools used, the materials used, how to use them on plants, and the benefits of manure. cows as an environmentally friendly organic fertilizer. The results of this dedication show that the manufacture of organic fertilizer requires the addition of materials, namely sawdust, rice water, coconut water, and brown sugar solution with the aim of increasing the nutrients of organic fertilizer. The application of organic fertilizers on agricultural land can reduce the manufacture of chemical fertilizers, but can improve the nutrients in the soil. Abundant cow dung is a great result for fixing nutrients in soils that are already highly dependent on chemical fertilizers. Therefore, the manufacture of organic fertilizers needs to be continuously disseminated to the community, especially farmers in rural areas who lack information and technology. This is possible through activities, knowledge and training. This service program is carried out using two methods, namely: face-to-face socialization, the practice of making organic fertilizers.

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Volkov, V. P., and D. R. Salikhyanov. "ON RING DEFORMATION BY INTERNAL PRESSURE." Izvestiya. Ferrous Metallurgy 62, no. 3 (June 20, 2019): 195–200. http://dx.doi.org/10.17073/0368-0797-2019-3-195-200.

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Анотація:

Large-sized rings, manufactured by various methods of metal forming, are used in many industries. For the power industry, it is relevant to manufacture of retaining rings made of non-magnetic austenitic steel in order to strengthen the winding frontal parts of the rotors of turbine-type generators of a large unit capacity. In the process of generator operating, the retaining ring is one of the most loaded elements. As a result, material of retaining rings should have high strength properties, sufficient plasticity and good magnetic inductivity. Deformation of rings by internal pressure is the most promising and effective way of their cold hardening, providing a favorable and uniform stress-strain state of the metal in the manufacture of non-magnetic retaining rings for powerful turbine-type generators. Since the finished ring must acquire specific dimensions and a specified deformation degree in the process of cold hardening, the urgent task is calculation of the billet dimensions. The existing calculation procedure relies heavily on experimental manufacture data and is applicable only to a narrow range of rings, which reduces the accuracy of calculation and, ultimately, leads to an increase in ring allowances and a decrease in the metal utilization factor. In this research work a new technique for calculating the initial dimensions of rings, which is based on the incompressibility condition was developed and proposed. Taking into account the assumed boundary conditions, a system of two equations with three terms is compiled. To solve an incomplete equation system, it was suggested to introduce additional equations – in first version of the technique, the well-known solution of Nadai was used. In the second version – the condition of constancy of relative thickness of the ring wall permissible from the experimental data of deformation of rings of different sizes was used. The results of calculating the rings initial dimensions for both proposed techniques were compared with the experimental data. The maximum deviation from experimental data does not exceed 4 % and the deviation average value does not exceed 1 %, which indicates a sufficiently high accuracy of the proposed calculation techniques and the possibility of using them in manufacturing practice.

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Ouyang, Ba Sheng, Guo Xiang Lin, and Chun Liang Zhang. "The Key Technology of Hob Design for Hobbing Screw Compressor Rotors with Cycloid-Arc Profile." Advanced Materials Research 139-141 (October 2010): 823–26. http://dx.doi.org/10.4028/www.scientific.net/amr.139-141.823.

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The profile of cycloid-arc screw compressor rotors is not a smooth profile, and it has a tip on it. When designing the hob cutter is used for machining this kind of rotors, the profile of hob edge will appear separation. In this paper, the design theory of hob cutter for hobbing the no-symmetric cycloid-arc rotor with tip profile is researched, and the best way for design this kind of hob cutter with a separate edge is attained according to practical design, manufacture and test. Its results are shown that it is good practice to design the hob cutter and hob the cycloid-arc rotor. Thus, the machining method for hobbing screw compressor can enhance high productivity and machining accuracy.

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Putri, Anindya Aldhira. "ANALISIS LEVERAGE, UKURAN PERUSAHAAN, GOOD CORPORATE GOVERNANCE PADA MANAJEMEN LABA DENGAN STRUKTUR MODAL SEBAGAI VARIABLE MODERASI." Jurnal Akuntansi Trisakti 7, no. 2 (September 30, 2020): 303. http://dx.doi.org/10.25105/jat.v7i2.7216.

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The purpose of this analysis is to find the influence of leverage, company size, good corporate governance on earnings management with capital structure as the moderating variable. The sample of this research using the subsector of manufacture sector which is the foods and beverage subsector, from 2016 until 2018, with a requirement where the companies are listed in IDX. The companies samples of this research are 18 companies, with total of 54. The data of the research was processed by the SPSS.The final summary of the research is that, leverage doesn’t have any effect on earning management. As well as company size doesn’t any effect on earnings management because the bigger size of the company the lowest it is for the management to do the practice of earnings management, because their shareholders and creditors are critical on their report. Good corporate governance with an indicator of independent commissioner, board of directors, and internal committee also have a negative effect on earning management. In this research, capital structure weakens the effect of good corporate governance on earning management.

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Sur, Tania, Parama Sengupta, Ananya Mandal, and Nina Das. "Drug schedules: knowledge among undergraduate medical students in a government medical college in Eastern India." International Journal of Basic & Clinical Pharmacology 6, no. 7 (June 23, 2017): 1625. http://dx.doi.org/10.18203/2319-2003.ijbcp20172720.

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Background: In India many of the prescription only drugs (Schedule H) are available without prescription, leading to injudicious use, incidences of dangerous drug interactions, and unnecessary economic burden. Thus awareness among healthcare professionals and among common public are equally important. Objective was to assess the knowledge among undergraduate medical students in a government medical college in Eastern India regarding drug schedules in India.Methods: Willing 3rd semester and 5th semester students participated in the study. We used a pre-tested validated two-part questionnaire to assess the knowledge of undergraduate medical students regarding different drug schedules.Results: 5th semester students gave significantly higher correct answers (P<0.0001) regarding awareness about Drugs and Cosmetics Act 1940, different drug schedules in India, expiry period, guidelines for maintaining the details of standards for patent and proprietary medicines, guidelines regarding import and manufacture of new drugs, guidelines regarding import and manufacture of new drugs, any special license is required for the manufacture and sale of psychotropic drugs, drugs marketed only under “generic name”, guideline regarding pack size of drugs, and guidelines regarding good manufacturing practice (GMP)?. Analysis of second set of questionnaires revealed that the 5th semester students identified the different drug categories more correctly compared to the 3rd semester students.Conclusions: Doctors are one of the principle and reliable sources of drug information for the general population. Thus, it becomes relevant that the undergraduate medical students should regularly brush up their knowledge regarding drug regulations even after passing Pharmacology examination in the later years of training.

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Wang, Juan, Shuang Gao, Yufei Zhao, Taibing Fan, Mingkui Zhang, and Dehua Chang. "Manufacture and Quality Control of Human Umbilical Cord-Derived Mesenchymal Stem Cell Sheets for Clinical Use." Cells 11, no. 17 (September 1, 2022): 2732. http://dx.doi.org/10.3390/cells11172732.

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Анотація:

Human umbilical cord-derived mesenchymal stem cell (UC−MSC) sheets have attracted much attention in cell therapy. However, the culture media and coating matrix used for the preparation of UC−MSC sheets have not been safe enough to comply with current clinical drug standards. Moreover, the UC−MSC sheet preservation systems developed before did not comply with Good Manufacturing Practice (GMP) regulations. In this study, the culture medium and coating matrix were developed for UC−MSC sheet production to comply with clinical drug standards. Additionally, the GMP-compliant preservation solution and method for the UC−MSC sheet were developed. Then, quality standards of the UC−MSC sheet were formulated according to national and international regulations for drugs. Finally, the production process of UC−MSC sheets on a large scale was standardized, and three batches of trial production were conducted and tested to meet the established quality standards. This research provides the possibility for clinical trials of UC−MSC sheet products in the development stage of new drugs and lays the foundation for industrial large-scale production after the new drug is launched.

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Palousek, David, Jiri Rosicky, and Daniel Koutny. "Use of digital technologies for nasal prosthesis manufacturing." Prosthetics and Orthotics International 38, no. 2 (June 24, 2013): 171–75. http://dx.doi.org/10.1177/0309364613489333.

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Background and aim: Digital technology is becoming more accessible for common use in medical applications; however, their expansion in prosthetic and orthotic laboratories is not large because of the persistent image of difficult applicability to real patients. This article aims to offer real example in the area of human facial prostheses. Technique: This article describes the utilization of optical digitization, computational modelling, rapid prototyping, mould fabrication and manufacturing of a nasal silicone prosthesis. This technical note defines the key points of the methodology and aspires to contribute to the introduction of a certified manufacturing procedure. Discussion: The results show that the used technologies reduce the manufacturing time, reflect patient’s requirements and allow the manufacture of high-quality prostheses for missing facial asymmetric parts. The methodology provides a good position for further development issues and is usable for clinical practice. Clinical relevance Utilization of digital technologies in facial prosthesis manufacturing process can be a good contribution for higher patient comfort and higher production efficiency but with higher initial investment and demands for experience with software tools.

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Souralova, Tereza, Daniela Rehakova, Michal Jeseta, Lenka Tesarova, Jindrich Beranek, Pavel Ventruba, Ales Hampl, and Irena Koutna. "The Manufacture of Xeno- and Feeder-Free Clinical-Grade Human Embryonic Stem Cell Lines: First Step for Cell Therapy." International Journal of Molecular Sciences 23, no. 20 (October 18, 2022): 12500. http://dx.doi.org/10.3390/ijms232012500.

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Human embryonic stem cells (hESCs) are increasingly used in clinical trials as they can change the outcome of treatment for many human diseases. They are used as a starting material for further differentiation into specific cell types and to achieve the desirable result of the cell therapy; thus, the quality of hESCs has to be taken into account. Therefore, current good manufacturing practice (cGMP) has to be implemented in the transport of embryos, derivation of inner cell mass to xeno-free, feeder-free and defined hESC culture, and cell freezing. The in-depth characterization of hESC lines focused on safety, pluripotency, differentiation potential and genetic background has to complement this process. In this paper, we show the derivation of three clinical-grade hESC lines, MUCG01, MUCG02, and MUCG03, following these criteria. We developed and validated the system for the manufacture of xeno-free and feeder-free clinical-grade hESC lines that present high-quality starting material suitable for cell therapy according to cGMP.

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Yeanny, Mayang Sari, Yurnaliza, and Saleha Hannum. "The utilization of organic waste into fermented goat fodder in Tanjung Rejo village, Deli Serdang regency." ABDIMAS TALENTA: Jurnal Pengabdian Kepada Masyarakat 4, no. 2 (December 12, 2019): 514–18. http://dx.doi.org/10.32734/abdimastalenta.v4i2.4144.

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Community service activities with the title of The Utilization of Organic Waste into Fermented Goat Fodder in Tanjung Rejo Village, Deli Serdang Regency will be held in May - November 2019.The purpose of this community service is to utilize organic waste into fermented goat fodder in Tanjung Rejo village.Organic waste such as straw, banana tree and others can be converted into fermented goat fodder which is economical, nutritious and environmentally friendly.The specific target of this community service is that the fermented goat fodder produced can be stored for a long time with good quality.The method used is a combination of counselling, training, hands-on practice and work evaluation.The procedures of making fermented goat fodder are as follows; (1) Chop straw or banana tree using a chopper machine, this stage serves to make the fermentation process easier. (2) Prepare the place of manufacture, can use tarpaulins, large plastic or large barrels (3). Dissolve sugar or sugar cane with water plus SOC-HCS probiotic solution. (4) Enter the straw, husk and bran at the place of preparation that has been prepared previously. (5) Flush all materials that have been arranged evenly in the place of manufacture with a solution of sugar and SOC-HCS that had been dissolved with water. (6) Mix all ingredients evenly. (7) After everything has been stirred evenly, then cover the place of manufacture with a tarp or with anything, make sure to be airtight. (8) Wait for 1 - 14 days. The fermented fodder that you have made from straw will be ready or if the fermentation feed is made using a banana tree, it can be faster.All products produced can be used for their own needs or sold according to the needs of the people of Tanjung Rejo village, especially the Tanjung Rejo goat breeders group.

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Hock, Sia Chong, Sia Ming Kian, and Chan Lai Wah. "Global challenges in the manufacture, regulation and international harmonization of GMP and quality standards for biopharmaceuticals." Generics and Biosimilars Initiative Journal 9, no. 2 (June 15, 2020): 52–60. http://dx.doi.org/10.5639/gabij.2020.0902.010.

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Biopharmaceuticals belong to a class of medicinal products whose active pharmaceutical ingredient (API) is manufactured using living systems such as microbial and mammalian cells. With the patent expiry of the originator biopharmaceuticals, a surge in the production of biopharmaceuticals in the form of biosimilars is to be expected. However, biopharmaceuticals are inherently more complex than conventional chemical-based pharmaceuticals, hence requiring a more complicated manufacturing process. This paper provides a brief overview of the biopharmaceutical manufacturing processes and reveals that most biopharmaceuticals share similar processes and considerations. The complex nature of biopharmaceuticals presents various manufacturing challenges such as the inherent variation in quality and demand for extensive process and product understanding. Furthermore, downstream processing bottleneck also presents another manufacturing challenge. A brief comparison of the good manufacturing practice (GMP) standards of various regulatory authorities (RAs) and international organizations (IOs) reveals that the standards are largely similar and appropriate in addressing the manufacturing challenges. This review is one of the few covering the biopharmaceutical industry and the regulatory framework of the Association of South East Asian Nations (ASEAN). However, GMP alone does not address regulatory challenges such as evaluation of biosimilarity, differing outlook on interchangeability and a growing occurrence of data integrity lapses. Solutions such as the implementation of Industry 4.0, improved harmonization of regulatory efforts and creating a culture of quality within the organization may help to address the forgoing challenges.

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Lestari, Diah Puji, and Insih Wilujeng. "Edible Coating Starch Making for Preserving Fruit as an Alternative for Junior High School Science Practicum on Additives Substance Material." JURNAL PENDIDIKAN SAINS (JPS) 10, no. 1 (April 3, 2022): 1. http://dx.doi.org/10.26714/jps.10.1.2022.1-8.

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Анотація:

This research aimed to study the edible coating starch making for preserving fruit as an alternative for junior high school science practicum on additives substance material. The edible coating is a thin layer that can be consumed, inhibits microbial growth, and provides physical protection to the coated fruit. The steps to make edible coating starch carried out by the researchers are as follows: producing an eatable coating solution from cassava starch, making citronella extract fragrant, and application on fruit. Based on the results of research, edible coating starch with the addition of 30% citronella grass extract was the best treatment. Grapes could last up to 14 days of storage and showed a decrease in water content and fruit sugar by 72.22% and 4.80%, respectively. Based on the questionnaire of the teacher's responses to the manufacture of edible coating starch as an alternative to the science practicum, the results on the material aspects were in the marvelous category (90.62%), practical aspects were in a good category (79.01%), the cost and safety aspects were in the good category (85.11%). Therefore, it was possible to apply edible coating practice in schools.

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Dionisius Purwo Sudarsono. "Legal Protection of Registered Brand Holders (A case study of the infringement of the Kaso brand light steel)." Sociological Jurisprudence Journal 5, no. 2 (July 30, 2022): 86–90. http://dx.doi.org/10.22225/scj.5.2.2022.86-90.

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For companies that manufacture good products with registered trademarks that are known by the public, they definitely have good market shares. It is undeniable that many companies practice unfair business competition by imitating or using other parties’ registered trademarks to market their products. The objective of this research is to obtain a legal basis for trademark rights in Indonesian positive law and the implementation of legal protection for the holder of registered trademark of lightweight steel products under brand of "Kaso" from trademark infringement by other parties through a case study of lightweight steel brand counterfeiting. This type of this research is normative, which is legal research conducted through library research. The finding of the research indicates that the legal basis for the holder of registered trademark shall be Law No.20 of 2016 which provides 10 (ten) years of legal protection. The legal protection of registered trademarks includes the type of violation, the threat of punishment for the violation, granting the right to file a lawsuit with the Commercial Court, criminal charges for alleged trademark infringement through the Police and/or by choosing an alternative solution.

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Schmidt, Signe Tandrup, Dennis Christensen, and Yvonne Perrie. "Applying Microfluidics for the Production of the Cationic Liposome-Based Vaccine Adjuvant CAF09b." Pharmaceutics 12, no. 12 (December 19, 2020): 1237. http://dx.doi.org/10.3390/pharmaceutics12121237.

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Анотація:

Subunit vaccines require particulate adjuvants to induce the desired immune responses. Pre-clinical manufacturing methods of adjuvants are often batch dependent, which complicates scale-up for large-scale good manufacturing practice (GMP) production. The cationic liposomal adjuvant CAF09b, composed of dioctadecyldimethylammonium bromide (DDA), monomycoloyl glycerol analogue 1 (MMG) and polyinosinic:polycytidylic acid [poly(I:C)], is currently being clinically evaluated in therapeutic cancer vaccines. Microfluidics is a promising new method for large-scale manufacturing of particle-based medicals, which is scalable from laboratory to GMP production, and a protocol for production of CAF09b by this method was therefore validated. The influence of the manufacture parameters [Ethanol] (20–40% v/v), [Lipid] (DDA and MMG, 6–12 mg/mL) and dimethyl sulfoxide [DMSO] (0–10% v/v) on the resulting particle size, colloidal stability and adsorption of poly(I:C) was evaluated in a design-of-experiments study. [Ethanol] and [DMSO] affected the resulting particle sizes, while [Lipid] and [DMSO] affected the colloidal stability. In all samples, poly(I:C) was encapsulated within the liposomes. At [Ethanol] 30% v/v, most formulations were stable at 21 days of manufacture with particle sizes <100 nm. An in vivo comparison in mice of the immunogenicity to the cervical cancer peptide antigen HPV-16 E7 adjuvanted with CAF09b prepared by lipid film rehydration or microfluidics showed no difference between the formulations, indicating adjuvant activity is intact. Thus, it is possible to prepare suitable formulations of CAF09b by microfluidics.

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Rahmayanti, Fitria, Mahendra Mahendra, Munandar Munandar, Citra Dina Febrina, and Endah Anisa Rahma. "Pemanfaatan Probiotik untuk Budidaya Perikanan." Jurnal Pengabdian Masyarakat: Darma Bakti Teuku Umar 2, no. 1 (June 30, 2020): 179. http://dx.doi.org/10.35308/baktiku.v2i1.2045.

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Анотація:

Probiotics application in aquaculture sector has been promoted since the government has banned antibiotics application in aquaculture sector. Probiotics are very useful in aquaculture because it can accelerate fish growth, improve fish health, and maintain water quality in good condition. However, there are many fish farmers who do not know the advantages, manufacturing techniques and the application of probiotics to support aquaculture activities. Therefore, we have conducted this community service for fish farmers in Meunasah Sukon Village, Lembah Sabil District, Southwest Aceh Regency. This community service is carried out through counseling by describing the benefits of probiotics, followed by discussions with participants and probiotics practice using natural ingredients that are easily available. The result showed that the level of understanding and knowledge of fish farmers in this village about the benefits of probiotics, how to manufacture and its application were increases after this community service was conducted. The activities of enhancement fish farmer capacities are needed to improve their abilities about information on aquaculture renewable technology.

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Carvalho Gonçalves-Nunes, Etelvina María, Maria M. Gomes-Pereira, Amilton P. Raposo-Costa, Carlos A. Da Rocha-Rosa, Carina M. Pereyra, Rodrigo M. Calvet, Ana L. Alves-Marques, Francisco Cardoso-Filho, and Maria C. Sanches-Murator. "Screening of aflatoxin B1 and mycobiota related to raw materials and finished feed destined for fish." Latin American Journal of Aquatic Research 43, no. 3 (May 25, 2016): 595–600. http://dx.doi.org/10.3856/vol43-issue3-fulltext-22.

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The aim of the present study was to determine fungal genera, Aspergillus, Penicillium and Fusarium species and aflatoxin B1 contamination from raw materials and finished feed intended for fish farm localized in Piaui, Brazil. Aspergillus flavus and P. citrinum were isolated with a high relative density from all samples. In general, a high percent of samples exceeded the levels proposed as feed hygienic quality limits (CFU g-1) according to Good Manufacture Practice. Aflatoxin B1 was analyzed by enzyme-linked immunosorbent assay. All raw materials and finished feed showed aflatoxin B1 levels. Although in this study AFB1 levels below recommended limits (20 µg kg-1) were found, it is important to emphasize the feed intake with toxin in low concentrations along time, since it produce chronic deleterious effects in animal production. This fact requires periodic monitoring to prevent the occurrence of chronic aflatoxicosis in aquaculture, to reduce the economic losses and to minimize hazards to animal health.

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Wang, Rongqiao, Bin Zhang, Dianyin Hu, Kanghe Jiang, Jianxing Mao, and Fulei Jing. "Cyclic viscoplastic deformation modeling of a nickel-based single crystal superalloy with [001] orientation." MATEC Web of Conferences 165 (2018): 19005. http://dx.doi.org/10.1051/matecconf/201816519005.

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Accurate simulations of cyclic viscoplastic deformation behaviors of single crystal superalloys which are widely used for the manufacture of gas turbine blades are important for the effective design and safety assessment in practice. In this context, based on the in-phase thermomechanical fatigue (IP TMF) and out-of-phase thermomechanical fatigue (OP TMF) experiments of the nickel-based single crystal superalloy with [001] orientation, a modified constitutive model has been developed to describe the deformation behavior under thermomechanical loadings. The TMF experiment results indicate that stable hysteresis loops with remarkable ratcheting appear in both IP TMF and OP TMF. And it’s worth noticing that the ratcheting growth direction of IP TMF and OP TMF are opposite. By introducing a Schmid stress rate related term to the back stress evolution equation, the slip-based Walker’s constitutive model is modified in this study. And the simulation results of the deformation behavior reveal good agreement with the experiments under different IP TMF and OP TMF conditions.

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Profico, Daniela Celeste, Maurizio Gelati, Daniela Ferrari, Giada Sgaravizzi, Claudia Ricciolini, Massimo Projetti Pensi, Gianmarco Muzi, et al. "Human Neural Stem Cell-Based Drug Product: Clinical and Nonclinical Characterization." International Journal of Molecular Sciences 23, no. 21 (November 3, 2022): 13425. http://dx.doi.org/10.3390/ijms232113425.

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Translation of cell therapies into clinical practice requires the adoption of robust production protocols in order to optimize and standardize the manufacture and cryopreservation of cells, in compliance with good manufacturing practice regulations. Between 2012 and 2020, we conducted two phase I clinical trials (EudraCT 2009-014484-39, EudraCT 2015-004855-37) on amyotrophic lateral sclerosis secondary progressive multiple sclerosis patients, respectively, treating them with human neural stem cells. Our production process of a hNSC-based medicinal product is the first to use brain tissue samples extracted from fetuses that died in spontaneous abortion or miscarriage. It consists of selection, isolation and expansion of hNSCs and ends with the final pharmaceutical formulation tailored to a specific patient, in compliance with the approved clinical protocol. The cells used in these clinical trials were analyzed in order to confirm their microbiological safety; each batch was also tested to assess identity, potency and safety through morphological and functional assays. Preclinical, clinical and in vitro nonclinical data have proved that our cells are safe and stable, and that the production process can provide a high level of reproducibility of the cultures. Here, we describe the quality control strategy for the characterization of the hNSCs used in the above-mentioned clinical trials.

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Djebli, Ikram, Abdelkader Ameur Ameur, and Semir Bechir Suheil Gaouar. "General characteristics of goat milk cheese (Feta) in the region of Tlemcen, Algeria." GABJ 4, no. 3 (December 5, 2021): 60–73. http://dx.doi.org/10.46325/gabj.v4i3.131.

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Анотація:

Goat milk, whose production is starting to develop in Algeria in recent years, has a number of advantages that even allow it to substitute cow's milk. It is a source of health benefits for humans; it contains more vitamins with a significant cheese yield than cow's milk. Our present study aims to study physicochemical, microbiological and for the first time trials of a fresh cheese (Feta) made from locally selected goat's milk in the region of Tlemcen and its 10 regions namely: Ouled Mimoun, Terny, Sebdou, Ain El houte, Remchi, Bensakrane, Maghnia, Sabra, Nedroma and Zenata. 27 goats from the local population were used for this study. The physicochemical quality (fat, density, conductivity, defatted dry extract, temperature, protein, mineral salts and lactose) of the milk sampled was measured using a LACTOSCAN Milk-Analyzer. Four flora (total germ, fecal coliform, Staphylococcus aureus and salmonella) were chosen to test the microbiological quality of the milk. The results obtained show that the good physicochemical quality of milk studied in all regions except the two regions of Nedroma and Maghnia showing a high fat content. A total absence of contaminations for the three types of fecal coliform flora, Staphylococcus aureus and Salmonella nevertheless for the total germs are found in all sampled regions. These results show that healthy goats hence the good practice of milking is applied during sampling. The manufacture of cheese type feta based on goat's milk was made in good conditions (raw material, hygiene, mechanical work ...) which led to a cheese of microbiological quality and nutritional and an interesting yield. The good breeding condition with a balanced diet gives a good quality of the milk and consequences of these results give an excellent forming thanks to the professional techniques of manufacturing a good feta cheese.

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48

Payasan, Lalu Guntur, Arthur Josias S. Runturambi, and Iqrak Sulhin. "Medical Malpractice Transformation in the Internet of Medical Things Era." Technium Social Sciences Journal 38 (December 9, 2022): 204–19. http://dx.doi.org/10.47577/tssj.v38i1.7880.

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The Internet of medical things brought changes to the practice of medicine. The change is due to the inclusion of elements of devices and networks in medical services. The device and network elements in medical devices have many vulnerabilities that can lead to losses experienced by patients when they receive medical services. Therefore, this study will examine how these changes then have an impact on losses that in criminology are considered medical malpractice. A qualitative explanatory approach to both primary and secondary data is then used by researchers to support the argumentation. The results showed that the argument for the possibility of other perpetrators besides doctors who could then be interpreted as committing crimes that cause harm to patients was proven to be good from the responsibility of other human beings (electromedicine) as guarantors of device safety and reliability; manufacture and distributor of devices both from the prototype process, to use in health care facilities; and providers and hackers in the network used by healthcare devices. The impact can be seen in the discussion

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49

Kurniawan, Mohammad Dian, Deny Andesta, and Nina Aini Mahbubah. "Construction Of The Production Of Granule Bat Fertilizer In Smk Muhammadiyah 5 Panceng Gresik." INNOVATION RESEARCH JOURNAL 1, no. 2 (September 22, 2020): 89. http://dx.doi.org/10.30587/innovation.v1i2.1922.

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Fertilization is an action in plant care. Fertilization provides additional nutrients for the soil. Fertilization has a large influence on plant growth and production. Fertilization consists of organic and inorganic fertilizers. Both of these fertilizers must be balanced so that the nutrient content can be maintained properly. The use of fertilizers an organic fertilizer that is widely used, but the use of chemical fertilizers on an ongoing basis will reduce the level of soil fertility. This must be balanced with organic fertilizer. One of the organic fertilizer is guano fertilizer. This fertilizer is fertilizer made from animal waste, namely bats. This fertilizer has a very good content including nitrogen, phosphorus, and potassium. Knowledgethis fertilizer will still be low, so that an introduction and practice about guano fertilizer is needed. Therefore a community service activity was carried out on the development of the manufacture of guano fertilizer. Guano fertilizer development is carried out in the form of granules (granules). The targets of this service are vocational students who are related to agriculture. Vocational students are selected as the young generation to know about organic fertilizers and are able to contribute to the implementation of the agricultural industry. Community service activities were carried out with a presentation of the theory and practice of making guano fertilizer. As a result of this activity, students learned about organic fertilizer, namely guano fertilizer and its contents, nutrient content in the soil, balance in maintaining nutrient content in the soil, the practice of making guano fertilizer, and the creation of granule form from guano fertilizer.

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Kline, Rande. "Expiration Dating Of Chemicals And Reagents." Microscopy Today 8, no. 6 (August 2000): 42–43. http://dx.doi.org/10.1017/s155192950005286x.

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With today's requirements for chemicals and reagents in research and clinical laboratory environments, questions often arise concerning expiration dating. Why are not all chemicals and reagents expiration dated by the manufacturer when they are made? How should expiration of chemicals and reagents not dated by the manufacturer be determined? How would a laboratory establish expiration of solutions and reagents prepared in-house?To assure good manufacturing practices, many manufacturers comply with guidelines set for them by agencies such as the International Organization for Standardization (ISO) and are inspected by ISO auditors. Some manufacturers are required to comply with the Food and Drug Administration (FDA.) These manufacturers are known as GMP facilities (good manufacturing practices) and are assessed by FDA inspectors. Like regulatory agencies who govern clinical sites, ISO and FDA require manufacturers to establish uniform quality systems for product testing and certification.

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