884 resultados para Validation of analytical methodology
Resumo:
8 p.
Resumo:
ENGLISH: Increments in otoliths (sagittae) were examined, using light and scanning electron microscopy, to determine ages and estimate growth rates of larval and early-juvenile black skipjack, Euthynnus lineatus. Larvae and juveniles were collected between 1987 and 1989 from coastal waters of Panama in the eastern Pacific Ocean. Results from a laboratory experiment indicated that immersion for 6 and 12 hours in a 200 mg/L solution of tetracycline hydrochloride adequately marks otoliths and that increments are formed daily in the sagittae of postflexion larvae and early juveniles. Further, survival rates of tetracycline-treated fish were not significantly different from those of control fish. Growth rates were derived from length-age relationships of 218 field-collected specimens ranging in size from 5.7 to 20.3 mm SL. A growth rate of 0.70 mm/d was estimated from the weighted regression of standard length on age for all specimens. This rate lies within the range reported for larvae and early juveniles of other species of subtropical and tropical scombrids. Growth rates of postflexion larvae and early juveniles were not significantly different between the rainy season in July-August 1988 and the dry, upwelling season in January-February 1989. Growth was, however, significantly more variable for older individuals in July-August than in January-February, and may correspond, in part, to seasonal patchiness of prey. The growth rates of the otoliths relative to fish length were also not significantly different between seasons; however, the otoliths were larger relative to the lengths of fish collected in the rainy season, which may reflect slower growth during earlier larval stages. SPANISH: Se examinaron incrementos en otolitos (ságitas), usando microscopia de luz y de barrido electrónico, a fin de determinar la edad y estimar las tasas de crecimiento de barriletes negros, Euthynnus lineatus, larvales y juveniles tempranos. Entre 1987 y 1989 se capturaron larvas y juveniles en las aguas costeras de Panamá en el Océano Pacífico oriental. Los resultados de un experimento de laboratorio indicaron que una inmersión de 6 a 12 horas de duración en una solución de 200 mg/L de hidrocloro de tetraciclina marca los otolitos adecuadamente y que los incrementos se forman a diario en las ságitas de larvas en postflexión y juveniles tempranos. Además, las tasas de supervivencia de los peces tratados con tetraciclina no fueron significativamente diferentes a aquellas de los peces de control. Se calcularon las tasas de crecimiento a partir de las relaciones de talla-edad de 218 especímenes de TE entre 5.7 y 20.3 mm capturados en el mar. Se estimó.una tasa de crecimiento de 0.70 mm/día a partir de la regresión ponderada de talla estándar sobre edad para todos los especímenes. Esta tasa cae dentro del rango reportado para larvas y juveniles tempranos de otras especies de escómbridos subtropicales y tropicales. Las tasas de crecimiento de larvas en postflexión y juveniles tempranos no fueron significativamente diferentes entre la temporada de lluvias en julio-agosto de 1988 y la temporada de sequía y afloramiento en enero-febrero de 1989. Sin emoargo, el crecimiento fue significativamente más variable para los individuos de mayor edad en julio-agosto que en enero-febrero, y quizás corresponda parcialmente a la irregularidad temporal de la abundancia de presas. Las tasas de crecimiento de los otolitos en relación a la talla de los peces tampoco fueron significativamente diferentes entre temporadas; sin embargo, los otolitos eran más grandes en relación a la talla en peces capturados en la temporada de lluvias, lo cual podría reflejar crecimiento más lento durante las etapas larvales más tempranas. (PDF contains 42 pages.)
Resumo:
Validation is important in the design, development and production of medical devices since effective and appropriate validation plays a vital role in defining the success of a product in both technical and economic terms. Regulations and quality standards lay out the requirements for product validation, but it is left to each individual manufacturer to establish and maintain their own validation procedures. More recently, there has also been a change of emphasis in the regulations and standards that encourage the integration of validation into the development process. However, this poses particular challenges to the manufacturer since there is a distinct lack of guidance to assist this integration. This workbook provides the first real guidance on good design practices for medical device development. It has been developed through extensive consultation with device manufacturers and analysis of regulatory requirements. The approach is intended to assist manufacturers in meeting the new regulations.
Resumo:
IDOKI SCF Technologies S.L. is a technology-based company, set up on September 2006 in Derio (Biscay) with the main scope of developing extraction and purification processes based on the use of supercritical fluid extraction technology (SFE) in food processing, extraction of natural products and the production of personal care products. IDOKI¿s researchers have been working on many different R&D projects so far, most of them using this technology. However, the optimization of a SFE method for the different matrices cannot be performed unless we have an analytical method for the characterisation of the extracts obtained in each experiment. The analytical methods are also essential for the quality control of the raw materials that are going to be used and also for the final product. This PhD thesis was born to tackle this problem and therefore, it is based on the development of different analytical methods for the characterisation of the extracts and products. The projects that we could include in this thesis were the following: the extraction propolis, the recovery of agroindustrial residues (soy and wine) and the dealcoholisation of wine.On the one hand, for the extraction of propolis, several UV-Vis spectroscopic methods were used in order to measure the antioxidant capacity and the total polyphenol and flavonoid content of the extracts. A SFC method was also developed in order to measure more specific phenolic compounds. On the other hand, for the recovery of agroindustrial residues UV-Vis spectroscopy was used to determine the total polyphenol content and two SFC methods were developed to analyse different phenolic compounds. Extraction methods such as MAE, FUSE and rotary agitation were also evaluated for the characterisation of the raw materials.Finally, for the dealcoholisation of wine, the development of a SBSE-TD-GC-MS and DHS-TD-GC-MS methods for the analysis of aromas and a NIR spectroscopic method for the determination of ethanol content with the help of chemometrics was necessary. Most of these methods are typically used in IDOKI¿s lab as routine analyses apart from others not included in this PhD thesis.