ANVL -ohjelmiston käyttö protokollavalidoinnissa

Tietoliikennelaitteiden toiminta perustuu yleisesti sovittuihin standardeihin ja suosituksiin. Standardinmukaisuuden varmistamiseksi tuotteet tulee testata sekä standardeja että muita tuotteita vastaan, jotta laitteiden yhteensopivuudesta voidaan varmistua. Ohjelmistojen koon ja monimutkaisuuden jatkuvasti kasvaessa myös tarve löytää automatisoituja testausmenetelmiä kasvaa. Diplomityön tavoitteena oli selvittää soveltuuko ANVL -protokollavalidointiohjelmisto Tellabsin modeemituotteiden hyväksyntätestaukseen ja sovittaa ANVL osaksi Tellabsin testauskäytäntöä. Diplomityössä käydään lisäksi läpi ohjelmistotestauksen peruskäsitteitä ja esitetään ANVL:n sisäinen rakenne ja toimintaperiaatteet. Työssä havaittiin, että ANVL sopii hyvin yksittäisten datasiirtolaitteiden validointitestaukseen. ANVL:n räätälöintimahdollisuudet ovat hyvät ja sitä on mahdollista laajentaa itse toteutetuilla protokollavalidointipaketeilla. Tuote tullaan ottamaan käyttöön Tellabsin uusissa tuotekehitysprojekteissa.

Ensaios mecânico e aplicação da lógica fuzzy para avaliação do canote do garfo

A inovação tecnológica tem sido um dos fatores fundamentais que levam grandes empresas a permanecerem no topo do ranking mundial do mercado globalizado, de acordo com o avanço tecnológico o setor de engenharia tem buscado soluções que ofereçam resultados positivos em prol do crescimento de sua empresa ou organização. Métodos de simulação para avaliação do comportamento mecânico de produtos submetidos a cargas estáticas e cargas dinâmicas são extremamente necessárias para redução dos custos de fabricação dos produtos. O uso de ensaios mecânicos e virtuais é de vital importância para avaliação do produto. O presente trabalho teve como objetivo a utilização da lógica fuzzy em um produto chamado canote do garfo da bicicleta, onde foi analisado além do grau de pertinência variado entre 0 e 1, o grau de veracidade também variado entre 0 e 1, tendo como foco principal o comportamento do produto canote do garfo e sua validação.

Surface cloud radiative forcing from broadband radiation measurements on the Antarctic plateau

Surface based measurements systems play a key role in defining the ground truth for climate modeling and satellite product validation. The Italian-French station of Concordia is operative year round since 2005 at Dome C (75°S, 123°E, 3230 m) on the East Antarctic Plateau. A Baseline Surface Radiation Network (BSRN) site was deployed and became operational since January 2006 to measure downwelling components of the radiation budget, and successively was expanded in April 2007 to measure upwelling radiation. Hence, almost a decade of measurement is now available and suitable to define a statistically significant climatology for the radiation budget of Concordia including eventual trends, by specifically assessing the effects of clouds and water vapor on SW and LW net radiation. A well known and robust clear sky-id algorithm (Long and Ackerman, 2000) has been operationally applied on downwelling SW components to identify cloud free events and to fit a parametric equation to determine clear-sky reference along the Antarctic daylight periods (September to April). A new model for surface broadband albedo has been developed in order to better describe the features the area. Then, a novel clear-sky LW parametrization, based on a-priori assumption about inversion layer structure, combined with daily and annual oscillations of the surface temperature, have been adopted and validated. The longwave based method is successively exploited to extend cloud radiative forcing studies to nighttime period (winter). Results indicated inter-annual and intra-annual warming behaviour, i.e. 13.70 W/m2 on the average, specifically approaching neutral effect in summer, when SW CRF compensates LW CRF, and warming along the rest of the year due prevalentely to CRF induced on the LW component.

Properties comparison of Injected and SLS material

Most of the plastic injection companies are focused in the production of some products with a high exigency standard levels. That is why, to compete and gain some market share in front of the concurrency of companies from other countries, they need to be able to introduce new rapid prototyping techniques and product development.

Properties of seawater and particulate matter from a WETLabs AC-S spectrophotometer and a WETLabs chlorophyll fluorometer mounted on the continuous surface water sampling system during the Tara Oceans expedition 2009-2013

The Tara Oceans Expedition (2009-2013) was a global survey of ocean ecosystems aboard the Sailing Vessel Tara. It carried out extensive measurements of evironmental conditions and collected plankton (viruses, bacteria, protists and metazoans) for later analysis using modern sequencing and state-of-the-art imaging technologies. Tara Oceans Data are particularly suited to study the genetic, morphological and functional diversity of plankton. The present data publication provides permanent links to original and updated versions of validated data files containing measurements from the Continuous Surface Sampling System [CSSS]. Water was pumped at the front of the vessel from ~2m depth, then de-bubbled and circulated to a WETLabs AC-S spectrophotometer and a WETLabs chlorophyll fluorometer. Systems maintenance (instrument cleaning, flushing) was done approximately once a week and in port between successive legs. All data were stamped with a GPS.

An experimental validation of hypothetical WTP for a recyclable product

Using a within-subject experiment, we compare hypothetical and real willingness to pay (WTP) for an improvement in the recyclability of a product. Subjects are faced with a real payment scenario after they have responded to a hypothetical question. Contrary to most of the results obtained in similar studies, at apopulation level, there are no significant median differences between actual and hypothetical stated values of WTP. However,within-subject comparisons between hypothetical and actual values indicate that subjects stating a low (high) hypothetical WTP tend to underestimate (overestimate) the value of their actual contributions.

Development and validation of a simple, rapid and stability-indicating high performance liquid chromatography method for quantification of norfloxacin in a pharmaceutical product

A stability-indication high performance liquid chromatographic method has been developed for the determination of norfloxacin in tablet dosage forms. Optimum separation was achieved in less than 7 minutes using Eclipse Plus Zorbax C18 Agilent, 150 mm×4.6 mm i.d., 5 μm particle size column. The analyte was resolved by using a mobile phase 5% acetic acid aqueous solution and methanol (80:20, v/v) at a flow rate 1.0 ml/min on an isocratic high performance liquid chromatographic system at a wavelength of 277 nm. Linearity, system suitability, precision, sensitivity, selectivity, specific, and robustness were established by International Conference Harmonization guidelines. For stress studies the drug was subjected to photolysis, oxidation, acid, alkaline and neutral conditions. The analytical conditions and the solvent developed provided good resolution within a short analysis time and economic advantages. The proposed method not required sophisticated and expensive instrumentation.

Thermal analysis and validation of UV and visible spectrophotometric methods for the determination of new antibiotic tigecycline in pharmaceutical product

Fundação de Amparo à Pesquisa do Estado de São Paulo (FAPESP)

Design verification and validation in product lifecycle

The verification and validation of engineering designs are of primary importance as they directly influence production performance and ultimately define product functionality and customer perception. Research in aspects of verification and validation is widely spread ranging from tools employed during the digital design phase, to methods deployed for prototype verification and validation. This paper reviews the standard definitions of verification and validation in the context of engineering design and progresses to provide a coherent analysis and classification of these activities from preliminary design, to design in the digital domain and the physical verification and validation of products and processes. The scope of the paper includes aspects of system design and demonstrates how complex products are validated in the context of their lifecycle. Industrial requirements are highlighted and research trends and priorities identified. © 2010 CIRP.

Development and validation of sensitive methods for determination of sibutramine hydrochloride monohydrate and direct enantiomeric separation on a protein-based chiral stationary phase

Sibutramine hydrochloride monohydrate, chemically 1-(4-chlorophenyl)-N,N-dimethyl-alpha-(2-methylpropyl) hydrochloride monohydrate (SB center dot HCl center dot H2O), was approved by the U.S. Food and Drug Administration for the treatment of obesity. The objective of this study was to develop, validate, and compare methods using UV-derivative spectrophotometry (UVDS) and reversed-phase high-performance liquid chromatography (HPLC) for the determination of SB center dot HCl center dot H2O in pharmaceutical drug products. The UVDS and HPLC methods were found to be rapid, precise, and accurate. Statistically, there was no significant difference between the proposed UVDS and HPLC methods. The enantiomeric separation of SB was obtained on an alpha-1 acid glycoprotein column. The R- and S-sibutramine were eluted in < 5 min with baseline separation of the chromatographic peaks (alpha = 1.9 and resolution = 1.9).

Process Capability Indexes Determination on Tabletting Performance during the Process Validation for Metamizol Tablets

The aim of the present study was to provide a numerical measure, through the process capability indexes (PCIs), C(p) and C(pk), on whether or not the manufacturing process can be considered capable of producing metamizol (500 mg) tablets. They were also used as statistical tool in order to prove the consistency of the tabletting process, making sure that the tablet weight and the content uniformity of metamizol are able to comply with the preset requirements. Besides that, the ANOVA, the t-test and the test for equal variances were applied to this study, allowing additional knowledge of the tabletting phase. Therefore, the proposed statistical approach intended to assure more safety, precision and accuracy on the process validation analysis.

Ultra-Fast Gradient LC Method for Omeprazole Analysis Using a Monolithic Column: Assay Development, Validation, and Application to the Quality Control of Omeprazole Enteric-Coated Pellets

A method was optimized for the analysis of omeprazole (OMZ) by ultra-high speed LC with diode array detection using a monolithic Chromolith Fast Gradient RP 18 endcapped column (50 x 2.0 mm id). The analyses were performed at 30 degrees C using a mobile phase consisting of 0.15% (v/v) trifluoroacetic acid (TFA) in water (solvent A) and 0.15% (v/v) TFA in acetonitrile (solvent B) under a linear gradient of 5 to 90% B in 1 min at a flow rate of 1.0 mL/min and detection at 220 nm. Under these conditions, OMZ retention time was approximately 0.74 min. Validation parameters, such as selectivity, linearity, precision, accuracy, and robustness, showed results within the acceptable criteria. The method developed was successfully applied to OMZ enteric-coated pellets, showing that this assay can be used in the pharmaceutical industry for routine QC analysis. Moreover, the analytical conditions established allow for the simultaneous analysis of OMZ metabolites, 5-hydroxyomeprazole and omeprazole sulfone, in the same run, showing that this method can be extended to other matrixes with adequate procedures for sample preparation.

Development and Validation of a Simple Method for Routine Analysis of Ractopamine Hydrochloride in Raw Material and Feed Additives by HPLC

A simple method was optimized and validated for determination of ractopamine hydrochloride (RAC) in raw material and feed additives by HPLC for use in quality control in veterinary industries. The best-optimized conditions were a C8 column (250 x 4.6 mm id, 5.0 mu m particle size) at room temperature with acetonitrile-100 mM sodium acetate buffer (pH 5.0; 75 + 25, v/v) mobile phase at a flow rate of 1.0 mL/min and UV detection at 275 nm. With these conditions, the retention time of RAC was around 5.2 min, and standard curves were linear in the concentration range of 160-240 mu g/mL (correlation coefficient >= 0.999). Validation parameters, such as selectivity, linearity, limit of detection (ranged from 1.60 to 2.05 mu g/mL), limit of quantification (ranged from 4.26 to 6.84 mu g/mL), precision (relative standard deviation <= 1.87%), accuracy (ranged from 96.97 to 100.54%), and robustness, gave results within acceptable ranges. Therefore, the developed method can be successfully applied for the routine quality control analysis of raw material and feed additives.

Validation of a Spectrophotometric Method for Quantification of Carboxyhemoglobin

Universidade de São Paulo - LIM[40/HC-FM-USP]