Estratégia para validação de processos de esterilização por vapor saturado em autoclaves nas indústrias farmacêuticas

O objetivo deste trabalho foi criar uma metodologia de validação e revalidação dos processos de esterilização por calor úmido em autoclaves horizontais, destacando os pontos críticos do processo e concentrando esforços onde são realmente necessários. Foram realizados estudos de distribuição térmica, de penetração de calor e de desafio microbiológico na validação da autoclave STERIS FINNAQUA 6912. Com o objetivo de avaliar o impacto de uma mudança e compreender a relação entre os fatores e suas interações para o processo de esterilização, foi utilizado o planejamento fatorial 23 dos fatores densidade da carga (quantidade de itens), embalagem do produto e localização na câmara interna. Os estudos de distribuição térmica confirmaram a distribuição homogênea de calor na câmara interna durante o tempo de exposição a 121C. As temperaturas variaram entre 120,35C e 120,92C com desvio padrão máximo de 0,12C. Os estudos de penetração de calor confirmaram exposições equivalentes a 121C por 24 minutos em todos os itens da carga (F0 > 24 minutos). Em todos os estudos para cargas secas, os índices de capacidade do processo (Cpk) foram maiores que 1,33. Os ensaios de desafio microbiológico garantiram níveis de esterilidade (S.A.L.) maiores que 12 reduções logarítmicas em relação aos indicadores biológicos Geobacillus stearothermophilus. Não foi detectada a presença de endosporos sobreviventes nos 132 indicadores biológicos utilizados nos quatro ciclos desafiados. Com base no planejamento experimental verificou-se que, para o nível de significância de 95% , as mudanças nos fatores posição, embalagem e quantidade da carga não são significativas para o processo de esterilização, em autoclave com remoção forçada de ar. Já para o nível de significância de 90%, a interação Posição x Embalagem apresentou significância estatística no processo de esterilização com valor P de 0,080

Preparation and attempted resolution of benzoyl-malic acid

The final object of this research was to prepare m-nitrobenzoyl malic acid and to separate it, if possible, into the four stereoisomers predicted by the Huggins' theory of the benzene ring. Inasmuch as the quantity of m-nitro- benzoyl chloride available was limited it was thought better to first prepare i-benzoyl malic acid and then attempt to resolve it. The resolution of m-nitrobenzoyl malic acid could probably be accomplished by a similar method.

Ab initio study of anharmonicity in high pressure Cmca-4 metallic hydrogen

Hydrogen is the only atom for which the Schr odinger equation is solvable. Consisting only of a proton and an electron, hydrogen is the lightest element and, nevertheless, is far from being simple. Under ambient conditions, it forms diatomic molecules H2 in gas phase, but di erent temperature and pressures lead to a complex phase diagram, which is not completely known yet. Solid hydrogen was rst documented in 1899 [1] and was found to be isolating. At higher pressures, however, hydrogen can be metallized. In 1935 Wigner and Huntington predicted that the metallization pressure would be 25 GPa [2], where molecules would disociate to form a monoatomic metal, as alkali metals that lie below hydrogen in the periodic table. The prediction of the metallization pressure turned out to be wrong: metallic hydrogen has not been found yet, even under a pressure as high as 320 GPa. Nevertheless, extrapolations based on optical measurements suggest that a metallic phase may be attained at 450 GPa [3]. The interest of material scientist in metallic hydrogen can be attributed, at least to a great extent, to Ashcroft, who in 1968 suggested that such a system could be a hightemperature superconductor [4]. The temperature at which this material would exhibit a transition from a superconducting to a non-superconducting state (Tc) was estimated to be around room temperature. The implications of such a statement are very interesting in the eld of astrophysics: in planets that contain a big quantity of hydrogen and whose temperature is below Tc, superconducting hydrogen may be found, specially at the center, where the gravitational pressure is high. This might be the case of Jupiter, whose proportion of hydrogen is about 90%. There are also speculations suggesting that the high magnetic eld of Jupiter is due to persistent currents related to the superconducting phase [5]. Metallization and superconductivity of hydrogen has puzzled scientists for decades, and the community is trying to answer several questions. For instance, what is the structure of hydrogen at very high pressures? Or a more general one: what is the maximum Tc a phonon-mediated superconductor can have [6]? A great experimental e ort has been carried out pursuing metallic hydrogen and trying to answer the questions above; however, the characterization of solid phases of hydrogen is a hard task. Achieving the high pressures needed to get the sought phases requires advanced technologies. Diamond anvil cells (DAC) are commonly used devices. These devices consist of two diamonds with a tip of small area; for this reason, when a force is applied, the pressure exerted is very big. This pressure is uniaxial, but it can be turned into hydrostatic pressure using transmitting media. Nowadays, this method makes it possible to reach pressures higher than 300 GPa, but even at this pressure hydrogen does not show metallic properties. A recently developed technique that is an improvement of DAC can reach pressures as high as 600 GPa [7], so it is a promising step forward in high pressure physics. Another drawback is that the electronic density of the structures is so low that X-ray di raction patterns have low resolution. For these reasons, ab initio studies are an important source of knowledge in this eld, within their limitations. When treating hydrogen, there are many subtleties in the calculations: as the atoms are so light, the ions forming the crystalline lattice have signi cant displacements even when temperatures are very low, and even at T=0 K, due to Heisenberg's uncertainty principle. Thus, the energy corresponding to this zero-point (ZP) motion is signi cant and has to be included in an accurate determination of the most stable phase. This has been done including ZP vibrational energies within the harmonic approximation for a range of pressures and at T=0 K, giving rise to a series of structures that are stable in their respective pressure ranges [8]. Very recently, a treatment of the phases of hydrogen that includes anharmonicity in ZP energies has suggested that relative stability of the phases may change with respect to the calculations within the harmonic approximation [9]. Many of the proposed structures for solid hydrogen have been investigated. Particularly, the Cmca-4 structure, which was found to be the stable one from 385-490 GPa [8], is metallic. Calculations for this structure, within the harmonic approximation for the ionic motion, predict a Tc up to 242 K at 450 GPa [10]. Nonetheless, due to the big ionic displacements, the harmonic approximation may not su ce to describe correctly the system. The aim of this work is to apply a recently developed method to treat anharmonicity, the stochastic self-consistent harmonic approximation (SSCHA) [11], to Cmca-4 metallic hydrogen. This way, we will be able to study the e ects of anharmonicity in the phonon spectrum and to try to understand the changes it may provoque in the value of Tc. The work is structured as follows. First we present the theoretical basis of the calculations: Density Functional Theory (DFT) for the electronic calculations, phonons in the harmonic approximation and the SSCHA. Then we apply these methods to Cmca-4 hydrogen and we discuss the results obtained. In the last chapter we draw some conclusions and propose possible future work.

The relationship between boat size and fish catches in the gillnet fishery of Lake Victoria, Uganda

The number and size composition of gillnets, fishing grounds, and the quantity and composition of fish catches were related to the size of fishing boat. The overall number of gillnets per boat increased from 20.9 + or - 2.3 nets in 5-6 m long boats to 88.6 + or - 11.8 nets in 11-12 m long boats. The proportion of large mesh sizes, + or more than 127 mm, also increased from 40% in 5-6 m long boats to 100% in boats longer than 10 m. Fish catches are related to the size of boat and this should be considered when formulating management guidelines of the lake's fishery. Promotion of large fishing boats 8 m or longer and restriction on the number and/or mesh size of gillnets of smaller boats could increase ecological and socio-economic benefits.

Influence of temperature and salinity fluctuations on propagation behaviour of partially coherent beams in oceanic turbulence

A theoretical study of the behaviour of partially coherent beams propagating through oceanic turbulence has been performed. Based on the previously developed knowledge of beam spreading of a partially coherent beam in the atmosphere and the spatial power spectrum of the refractive index of ocean water, we study the normalized root-mean-square width of a partially coherent beam on propagation through oceanic turbulence and its turbulence distance which may be a measure of turbulence resistance. Our analysis indicates that the behaviour of partially coherent beams on propagation may be described by the rate of dissipation of the mean-squared temperature chi(T) and that of salinity chi(S). In terms of a quantity w that defines the contributions of the temperature and salinity distributions to the distribution of the refractive index, chi(S) could be written as a function of chi(T) and w. Therefore, the behaviour of partially coherent beams on propagation can be characterized only by chi(T) for a given w. The results are shown for curved surfaces, from which one can see that partially coherent beams exhibit robust turbulence resistance when the water volume has a smaller chi(T).