Statistical process control of manufacturing tablets for antiretroviral therapy

Abstract In this study, the manufacturing process of lamivudine (3TC) and zidovudine (AZT) tablets (150+300 mg respectively) was evaluated using statistical process control (SPC) tools. These medicines are manufactured by the Fundação para o Remédio Popular "Chopin Tavares de Lima" (FURP) laboratory, and are distributed free of charge to patients infected with HIV by the Ministry of Health DST/AIDS national program. Data of 529 batches manufactured from 2012 to 2015 were collected. The critical quality attributes of weight variation, uniformity of dosage units, and dissolution were evaluated. Process stability was assessed using control charts, and the capability indices Cp, Cpk, Pp, and Ppk (process capability; process capability adjusted for non-centered distribution; potential or global capability of the process; and potential process capability adjusted for non-centered distribution, respectively) were evaluated. 3TC dissolution data from 2013 revealed a non-centered process and lack of consistency compared to the other years, showing Cpk and Ppk lower than 1.0 and the chance of failure of 2,483 in 1,000,000 tablets. Dissolution data from 2015 showed process improvement, revealed by Cpk and Ppk equal to 2.19 and 1.99, respectively. Overall, the control charts and capability indices showed the variability of the process and special causes. Additionally, it was possible to point out the opportunities for process changes, which are fundamental for understanding and supporting a continuous improvement environment.

Comparison of local and imported osteosynthetic mandibular bone plates in terms of micro hardness in modified simulated body fluid at periodic intervals

To determine the micro hardness of novel Pakistani manufactured osteosynthetic titanium bone mini plates [MPP] and imported osteosynthetic titanium bone mini plates [MPG] in body like conditions. Descriptive study. This study was carried out at School of Chemical and Material Engineering, NUST from March to May 2013. Microvicker hardness tester was used for assessment of micro hardness of two types of plates. The hardness was checked before conditioning and after conditioning at [six different places] on interval of 1, 7, 14, 21, 28 and 40 days in modified simulated body fluid with ph 7.4 and temperature 37[degree]C. Result showed that hardness of MPG was higher than MPP and after conditioning in simulated body fluid at all time periods, hardness of both types of plates was increased. It can be concluded from this study that micro hardness of imported plates is more than local plates so recommendations should be sent to manufacturers of local industry of Pakistan to improve the hardness of local plates so that they can meet international standards

Data integration, data mining and visualization analysis of traditional Chinese medicine manufacturing process / 中国中药杂志

Huge amount of data becomes available from the pharmaceutical manufacturing process with wide application of in- dustrial automatic control technology in traditional Chinese medicine (TCM) industry. The industrial big data thus provides golden op- portunities to better understand the manufacturing process and improve the process performance. Therefore it is important to implement data integration and management systems in TCM plants to easily collect, integrate, store, analyze, communicate and visulize the data with high efficiency. It could break the data island and discover useful information and knowledge to improve the manufacturing process performance. The key supporting technologies for TCM manufacturing and industrial big data management were introduced in this paper, with a specific focus on data mining and visualization technologies. Using historic data collected from a manufacturing plant of Shengmai injection of SZYY group, we illustrated the usefulness and discussed future prospects of data mining and visualization technologies.

Valoración cualitativa de la calidad en cápsulas fitomedicinales comercializadas en farmacias y establecimientos botánicos en el país, en el periodo comprendido de enero-noviembre del año 2012 / Qualitative evaluation of the quality in phytomedicinal capsules sold in pharmacies and botanical establishments in the country, in the period from January to November of the year 2012

En el año 2011, se realizaron investigaciones acerca de presentaciones farmacéuticas de fitofármacos mayormente comercializada (Indagar la presentación fitofarmacéutica mayormente comercializada en farmacias botánicas de los departamentos de Managua, León, Chinandega y Estelí, R Bustillo. C. Cruz. H Loaisiga., K. Núñez); y sobre verificación de la calidad microbiológica y fitoquímica de cápsulas Fitomedicinales(Verificación de la calidad de un producto Fitoterapico en capsulas comercializadas en los Departamentos de Managua, Estelí y León, J. L. Silva G., M. Y. Valle V., K. Núñez),; de los cuales se concluyó que el uso y la comercialización de fitofármacos y productos naturales bajo la presentación de cápsulas es el producto mayormente comercializado lo cual es propenso para adulteraciones y falsificaciones. Dichos estudios hicieron hincapié en la valoración fitosanitaria (control de calidad microbiológico) de productos de esta naturaleza, por lo cual en el presente estudio se hace relevancia no al contenido de principios activos, sino más bien al empaque primario de la presentación fitomedicinal el cual es el primer parámetro que debe valorarse para la verificación del cumplimiento de buenas prácticas de manufactura y diseño, puesto que son pautas fundamentales y de relevancia como parte de I+D (investigación y diseño) presentación farmacéutica (cápsulas), por ello se pretende que éste sea un aporte a estudios de productos Fitomedicinales desde el punto de vista de controles a productos terminados que sirvan como marco referencial a las autoridades sanitarias correspondientes para la vigilancia de la calidad de los mismos. Asi mismo a la mejora continua del vigente reglamento centro americano de verificación de la calidad de productos naturales R.T.C.A 11.03.56.09 Tras la conclusión del estudio se hizo evidente que el control riguroso de formas farmacéuticas sólidas es necesario siendo que la calidad de productos como Pasinerva se diferencia notablemente en comparación a productos elaborados de forma inescrupulosa que no cuentan con registro sanitario ni calidad de empaque primario (cápsulas) , lo cual pone en riesgo la salud de consumidores.

Application of multivariate techniques in the evaluation of melt granulation products

In this work, principal component analysis and cluster analysis were applied as helping tools to extract useful information in the development of formulations and manufacturing processes of melt granulates. Two melt granulation processes that differ in the shear stress applied to the solid bed during melting step were designed. These processes employ equipment frequently used in the local pharmaceutical industry. The selected binders include both hydrophilic and hydrophobic excipients, which were used alone or in binary mixtures. Granulates were characterized regarding their physicomechanical properties, including their compaction behavior. The resulting tablets were also evaluated. The selected multivariate statistical methods proved to be useful in facilitating the interpretation of the collected data and the study of the properties of granulates and tablets, as well as the selection of more efficient production processes.

Neste trabalho, foram aplicadas as técnicas de análise de componentes principais e de análise de agrupamentos para extrair informações úteis no desenvolvimento de formulações e de processos de produção de granulados por fusão. Desenharam-se dois processos de granulação por fusão que apresentam diferenças na tensão de cisalhamento aplicada ao leito sólido durante a etapa de fusão. Esses processos empregam equipamentos frequentemente usados na indústria farmacêutica local. Os ligantes escolhidos incluíram excipientes tanto hidrofílicos quanto hidrofóbicos, utilizados de forma individual ou em misturas binárias. Os granulados foram caracterizados quanto às suas propriedades físico-mecânicas, incluindo seu desempenho no processo de compactação. Os comprimidos resultantes também foram avaliados. Os métodos de análise multivariada escolhidos provaram ser úteis para facilitar a interpretação dos dados coletados e o estudo das propriedades dos granulados e dos comprimidos, bem como a seleção de processos de produção mais eficientes.

Verificación de la calidad de un fitoterápico en capsulas comercializado en los departamentos de Managua, Estelí y León, durante octubre 2010 / Verification of the quality of a phytotherapic in capsules marketed in the departments of Managua, Estelí and León, during October 2010

La calidad de los productos Fitoterápicos debe ser un aspecto a considerar por las autoridades sanitarias de nuestro país, en la actualidad la globalización y la armonización mediante los tratos de libre comercio han llevado a nuestros países a declarar reglamentos que puedan garantizar en alguna medida la calidad de dichos productos Como es sabido la calidad de los productos naturales o Fitoterápicos no es homogénea desde sus materias primas que suelen ser material vegetal que se encuentra expuesto a altos índices de contaminación desde su cultivo principalmente por microorganismos los que frecuentemente suelen ser patógenos (Estafilococos, Salmonella, Shiguella,E.coli entre algunos), y no de menor importancia esta la calidad química de los compuestos que contienen y suelen ser los de propiedades fitoterapéuticas. Actualmente existe en Nicaragua un Reglamento técnico centroamericano (R.T.C.A) 11.03.56.09 para la verificación de la calidad de productos naturales como producto de la armonización de la unión aduanera de nuestros países centro americanos pero este tiene como debilidad el estar orientado a determinar pruebas microbiológicas y únicamente pruebas de identificación para componentes activos en los productos, omitiendo la relevancia de cuantificación del contenido químico de los principales constituyentes de las plantas, por los cual debería conocerse al menos el mínimo permitido de los compuestos con actividad fitoterapéutica en las especies vegetales. En países en desarrollo se ha venido implementando metodologías que han permitido dar origen a los conocidos productos naturales estandarizados los que declaran el contenido químico aproximado de los componentes terapéuticos de las especies medicinales estos es en gran medida son un aporte para la inocuidad y seguridad que estos productos puedan brindar a sus consumidores ;Sin embargo los fabricantes de productos Fitoterápicos ven como un obstáculo dichos procesos por el coste de inversión que significa la estandarización sacrificando la calidad de los productos y la falta de seguridad para los consumidores.

Analysis of lung functions in flour mills and ricemills workers.

Aims: To study of the lung function tests in asymptomatic flour and rice mill workers and this study would be helpful in preventing longstanding harmful effects of such exposures and it is also useful for preventing environmental risks. Study Design: Cross – sectional study Material and Methods: The subject 207 asymptomatic healthy male is instructed to take maximal inspiration (to TLC) and he was connected to medspiror through the mouthpiece, after that nose clip is applied and the subject was asked to exhale forcefully into the medspiror as fast as possible. Statistical analysis: Statistical tests used like Student's ‘t’ test for two groups and ANOVA for multiple group comparisons. Results: Majority of lung function test parameters showed reduced levels in flour mill workers when compared to rice mill workers. However the difference was not statistically significant. Conclusion: It is concluded that flour dust and rice husk dust causes deterioration of pulmonary functions in subjects working at mills (flour and rice). The findings of this study recognized the role of grain dust (flour and rice) for a longer duration in decline of pulmonary function test among flour mills and rice mills workers.

The effect of evidence-based evaluation and economic evaluation for price control of medical disposable materials / 中国医疗器械杂志

Evidence-based evaluation and economic evaluation could be identical to the products which should be priced by bidding or which should be listed individually through evidence-based evaluation. Meanwhile, economic evaluation is helpful to price listing individual products in a reasonable range. It will be extremely grateful if all colleagues can be a part of the program and set up a standard pricing rationale in science.

Heat exposure assessment in the working environment of a glass manufacturing unit

Heat stress is a common health problem throughout industry. Any heat stress evaluation requires some exposure assessment of climatic conditions, especially air temperature, humidity, and speed, along with the average temperature of the solid surroundings. In this paper workplace environmental climatic parameters were measured and then evaluated by Wet Bulb Globe Temperature, Corrected Effective Temperature, Heat Stress Index, and Allowable Exposure Time indices among 40 workers in a glass manufacturing unit in Tehran. Also, the effect of available heat control devices on heat stress indices was investigated. The results of this study showed that the obtained heat stress index in individual section and press units is exceeded from 100 [in individual section unit: 302.6, in press unit: 283.6]. Also, it is found that the mean average of allowable exposure time in individual section and press units were 13.15 and 12.26 minutes exposure for one hour, respectively. No significant relationship was found between environmental parameters in three parts of body regions [height of head, abdomen and ankle] except for measured air velocity in both units [P<0.007]. Positive correlation was found between wet bulb globe temperature, corrected effective temperature and heat stress index indices, but negative correlation was found between allowable exposure time and other indices. Mann Whitney non-parametric test revealed significant relationships in wet bulb globe temperature, corrected effective temperature, heat stress index and allowable exposure time indices when metallic shield was used as heat absorber

Difficult ventilation in a patient after Endotracheal intubation: an unusual manufacturing defect in E.T.T. connecter

Airway resistance depends upon the diameter of endotracheal tube [E.T.T] and other respiratory organs. Actually resistance to flow through a tube increases up to sixteen times if diameter is reduced to half of the original size. Disposable E.T.T which are currently used in anaesthesia practice are made up of P.V.0 with a connecter which is fitted on proximal end of endotracheal tube and proximal end of connector is attached with breathing circuit. Usually the internal diameter of connector should be equal to internal diameter of endotracheal tube. In the market, tubes of different manufacturers and of different sizes are available for all age groups. In developing countries like Pakistan, hospital administration usually purchases the endotracheal tubes and other equipments which are relatively cheaper because of lack of funds. Here we present a case where there was a manufacturing defect in E.T.T connector with a very narrow internal diameter that was causing severe respiratory obstruction in a child undergoing laparotomy. We conclude that the anaesthetists must keep in their mind the possibility of E.T.T connector manufacturing defect if they face problem of increased airway resistance in an intubated patient after excluding other possibilities of high airway resistance

Biodegradation of reactive textile dyes by basidiomycetous fungi from brazilian ecosystems

The potential of Trametes villosa and Pycnoporus sanguineus to decolorize reactive textile dyes used for cotton manufacturing in the State of Minas Gerais, Brazil, was evaluated. Growth and decolorization halos were determined on malt extract agar containing 0.002g L-1 of the dye. T. villosa decolorized all 28 of the tested dyes while P. sanguineus decolorized only 9. The effect of culture conditions (shaking and dye and nitrogen concentration) on the degradation of Drimaren Brilliant Blue dye was evaluated during growth of the fungi in liquid synthetic medium. Shaking favored degradation and decolorization was not repressed by nitrogen. In pure culture, T. villosa and P. sanguineus decolorized synthetic effluent consisting of a mixture of 10 dyes. Higher decolorization of the synthetic effluent was observed when a mixed culture of the two fungi was used. This study demonstrated differences between tropical basidiomycete species in terms of their ability to degrade reactive dyes, and reinforces the potential of this group of fungi for the decolorization of textile effluents.

O potencial de Trametes villosa e Pycnoporus sanguineus de descolorir corantes têxteis reativos utilizados na manufatura de algodão no estado de Minas Gerais foi avaliado. Halos de crescimento e descoloração foram determinados em agar extrato malte (MEA) com 0,002g L-1 do corante. T. villosa descoloriu os 28 corantes testados e P. sanguineus apenas 9. A influência de condições de cultivo (agitação, concentração de corante e concentração de nitrogênio) na degradação do corante azul brilhante Drimaren foi avaliada durante crescimento dos fungos em meio líquido sintético. Agitação favoreceu a degradação e não foi observada repressão da descoloração pelo nitrogênio. Em cultura pura, T. villosa e P. sanguineus descoloriram efluente sintético constituído por uma mistura de dez corantes. Maior descoloração do efluente sintético foi observada no cultivo misto destes dois fungos. Este estudo evidenciou diferenças entre espécies de basidiomicetos tropicais na capacidade em degradar corantes reativos e reforçou o potencial deste grupo de fungos para a descoloração de efluentes têxteis.

Health safety of main water pipe materials supplied in China market / 生物医学与环境科学（英文）

<p><b>OBJECTIVE</b>To assess the health safety of copper, steel and plastic water pipes by field water quality investigations.</p><p><b>METHODS</b>Four consumers were randomly selected for each type of water pipes. Two consumers of every type of the water pipes had used the water pipes for more than 1 year and the other 2 consumers had used the water pipes for less than 3 months. The terminal volume of tap water in copper and steel water pipes should be not less than 0.1 liter, whereas that in plastic water pipes should be not less than 1 liter.</p><p><b>RESULTS</b>The mean values of the experimental results in the second field water quality investigation of the copper and steel water pipes met the Sanitary Standards for Drinking Water Quality. The items of water sample of the plastic water pipes met the requirements of the Sanitary Standards for Drinking Water Quality.</p><p><b>CONCLUSION</b>Copper, steel, and plastic pipes can be used as drinking water pipes.</p>

Value added eco-friendly products from tannery solid wastes.

Chrome shavings are the prominent solid wastes in tanning industry. Since chromium is known for its toxicity, the disposal of chrome shavings has been identified as a serious problem from the environmental point of view. At present, the popular utilization mode for chrome shavings is the manufacture of leather boards and related products. But this does not offer complete utilization of chrome shavings. Moreover, return per ton of chrome shavings is low if used for leather board production. In view of this, two processes have been developed to offer an alternative and better solution for the disposal of chrome shavings.The first process is preparation of parchment like membrane and the second process is related to development of leather like material. These products are analyzed for their mechanical behavior and other physicochemical properties. Parchment membrane can be used in the preparation of lampshades, chandeliers, wall hangers, table tops etc. and leather like material can be used in the preparation of chappal uppers, hand bags, purses, valets etc. The utilization of the chrome shavings in preparation of those two products not only reduces the environmental pollution but at the same time value added products can also be obtained.

Hydrogenation properties of mechanically milled Mg2Ni0.8Cr0.2-CoO/Al2O3 composites / 浙江大学学报（英文版）（B辑：生物医学和生物技术）

Mg2Ni0.8Cr0.2-x wt.% CoO/Al2O3 (x=0.5, 1, 2 and 3) composites were prepared by mechanically milling sintered Mg2Ni0.8Cr0.2 alloy and CoO/Al2O3 compound for 45 h. The addition of CoO/Al2O3 compound resulted in the good kinetics properties of hydriding/dehydriding reaction of the composites. The composite with 1.0 wt.% CoO/Al2O3 catalyst could reach the maximum hydrogen absorption capacity (2.9 wt.%) within 5 min at 393 K under H2 pressure of 4 MPa, and can desorb rapidly at 493 K. The decomposition and synthesis of hydrogen molecule on Mg2Ni0.8Cr0.2 alloy surface was promoted by addition of CoO/Al2O3 catalyst. In addition, the formation of metallic Ni particles, strain and defects during the ball milling process also resulted in the improved hydrogenation performance of Mg2Ni-based alloys.

Egyptian adopted plastic curd cheese varieties, provolone, mozzarella, medaffarah and halloumi: an overview

Egyptian adopted provolone, mozzarella, medaffarah, halloumi and kashkaval are the most popular cheese varieties belonging to plastic curd or "Pasta filata" cheese varieties which originated in Italy, Eastern European and Balkan Peninsula and Middle Eastern countries. In Egypt, the previous cheese varieties are adopted and produced. This review considers the manufacture process, milk used, different additives to milk on chemical composition, microbiological, rheological, and organoleptic properties of provolone, mozzarella, medaffarah and halloumi cheese varieties

Influence of packaging materials on the oxidative stability of stripped soybean oil

Stripped soybean oil was used to investigate the effect of different packaging materials on photooxidation stability. Four packaging materials were used, two glass [clear and amber] and two plastic [low density polyethelene PE and polyethylene terephthalate PET]. Clear glass caused the highest hydroperoxide formation followed by PE and PET while amber glass caused the least one, since it excluded most of the incident light responsible for photoxidation, hence retarding it and decreasing off-flavour development. Also polyethylene terephthalate gave more inhibition of hydroperoxide than polyethylene. Polyethylene and polyethylene terephthalate packaging materials although they cause some of their constituents to migrate into edible oils, the over all amount migrated from them still below the international permitted level

Suggested mortars for restoration and conservation of some limestone historical structures

Conserving of weathered limestone historical structures is an important target for many interested Egyptian builders. Studying the original mortar of any limestone archeological building led to thinking about a new suitable mix design of mortar. The chemical composition of the old studied mortar shows enrichment in chlorides, ammonia and sulfates. Seven mixes composed of different quotients of sand, lime and gypsum were prepared for choosing the suitable one as restoring mortar. X-ray diffractograms of the suggested mortar mixes show composition of quartz, gypsum and calcium hydroxide as the main minerals comprising all mixes. Calcium silicate hydrate [C SH] and di- calcium silicate hydrate [CSH] phases were detected with mixes, which contain considerable gypsum and sand. Mix No.1 [60% sand, 30% lime and 10% gypsum] is considered to be the best blend for mortar. Such mix achieved reasonable compressive strength, bulk density and water absorption values along all of the studied curing times. This work suggests that the using of sand, lime and gypsum mortars is adequate for repairing and conserving the historical and archeological limestone buildings

An environmental profile of brick kilns in Lucknow.

Twenty two kilns in Lucknow were studied to identify the environmental hazards posed by the brick kilns and to quantify the environmental degradation which could be attributed to this industry. Study variables comprised SPM and RSPM levels, metal concentrations and total silica content in soil, temperature, humidity and noise levels in the work environment. Information's about the nature and type of kiln, fuel and water sources was also collected. 18.18 per cent of the kilns had moving steel chimneys with less than prescribed height. Approximately 1.89 + 0.87 acre of fertile agricultural land was used for manufacturing of clay brick per kiln, resulting in land degradation decrease in herb density and nutrient disorders in plants/trees in immediate vicinity. SPM level (93.3 mg/m3) was found to be much higher than the prescribed limit. The workers engaged in these kilns were at risk from dust and heat related diseases.

Normas de buenas prácticas de manufactura para la industria del cosmético / Standards of good practices of manufacturing for the industry of the cosmetic

La Decisión 516 que constituye la norma que regula el comercio de los productos cosméticos en la región, incluyendo en dicha Decisión normas con el objeto de asegurar que los productos cosméticos sean fabricados de manera uniforme y controlada.