880 research outputs found
The other GMP: good manufacturing practice and its importance in the validation of constructed pharmaceutical facilities
The work reported is part of an ongoing PhD study prompted by the particular difficulties encountered when two very different quality cultures interact (in this case Pharmaceutical industry clients and Construction industry providers). Pharmaceutical facilities have particular needs for their production requirements. Stringent regulations are set by regulatory bodies such as the Medicines and Healthcare products Regulatory Agency (MHRA) (in the UK) and the Food and Drugs Administration (FDA) in the US. This creates special problems of quality when it comes to the commissioning, validation and hand-over of the building, as it appears to be at odds with the rather less demanding quality systems that are normally accepted in the construction sector. The aim of the research is to model an acceptable process for incorporating these stringent validation requirements into the design, procurement and construction processes. There is little or no specific academic literature on the subject, though the trades and professional press (particularly in the USA) provide some normative comment on the problem area. The main academic grounding of the research is in Systems Theory and empirical data is being collecting using a multiple case study approach. Research data was collected from a number of pharmaceutical facility construction case studies and was used to test and inform a best practice model of facility validation. The qualitative methods of participant and direct observation were used as the main information gathering tools. The paper reports on the regulatory expectations that influence the construction of projects of this type and the impact on the best practice model of validation
RRS Discovery Cruise 243, 11th October to 22nd November 1999. Sensory Biology in the Deep-Sea: Anatomy, Physiology, and Molecular Biology
RRS Discovery cruise 243 had two principal objectives: to collect deep-sea animals for a variety of biological studies ranging from physiology to molecular biology, and to deploy benthic landers. The landers are described in Section 9.1, and the midwater and benthic trawling in Section 9.2. A complete list of the stations worked, with times, latitudes and longitudes, is given in Section 10, and a track chart for the whole cruise is shown in Section 11.
Trawling was conducted first and foremost in order to provide specimens required for work associated with NERC grant GR3/B1212 âAnalysis of light-induced interactions in the deep-sea: bioluminescence and its relation to vision, reflectance and fluorescenceâ to Professor Peter Herring, Dr Julian Partridge, and Dr Peter Shelton. Of equal importance to the success of the cruise, however, was the provision of biological samples for a range of inter-related studies. Descriptions of these studies are given in Section 9.3.
Throughout the cruise a narrative (Section 6) was compiled to document, in diary format, the main scientific activities on board ship. It also records information about factors which affected work, such as the weather, and problems with equipment. The narrative is more or less a list of notes rather than proper prose, and was written during the cruise, documenting events as they were planned, as they unfolded, or after they had happened. In consequence, the tenses of verbs tend to vary in a haphazard way, for which I apologise.
During the cruise, the Discovery âRough Logâ of biological specimens was maintained by Professor Peter Herring. A prĂ©cis of some of the information from the Rough Log is incorporated into the narrative as a record of some of the most common, and some of the most unusual, animals that were collected. This is necessarily a biased record. Nevertheless, it may be useful to others planning or conducting similar cruises to the areas worked during D243, particularly those targeting the pelagic macrofauna.
As the narrative shows, D243 was plagued by problems with the main winch. At one stage, early in the cruise, the severity of these problems made it likely that the cruise would have to be terminated prematurely, without any trawling having been undertaken. That this situation was reversed is due to the determination and hard work of the RVS technicians who were on board the ship. To them, Phil Taylor (RVS Technical Liaison Officer/TLO), Kevin Smith (RVS Mobilisation Officer/MO), Paul Duncan, and Rhys Roberts, we are much indebted: without their labours the cruise would not have succeeded in the way it ultimately did.
Inevitably, the âscience timeâ of the cruise was affected by the winch problems (see Section 8) and was contributory to a decision not to work the slope of the African continent, which had been part of the original cruise directive. This was, however, to some extent compensated by the generally stable weather conditions in the work area. Although we encountered conditions more extreme than are indicated in the âAfrica Pilotâ for the region during October/November (anticipated average wind force 3), at no time was work stopped by poor weather. This in itself partly justifies the relatively long passage time to the work area. The main reason for working in the region, however, was the high diversity and abundance of midwater and benthic macrofauna in this region of upwelling and high surface water productivity. This, in combination with the trawling methods used, which included the use of the relatively large RMT25 net and a closing cod end on the RMT8 net, ensured that the requirements of the scientific personnel for specimens were well met.
The scientific complement of the cruise consisted of 23 people, ranging from graduate students to professors, from five countries and eleven institutions. In addition, the cruise also hosted a team from the BBC Natural History Unit, who were on board to film for the âThe Blue Planetâ, a television series about the seas which is due for release in 2001. That this diverse group (who are listed, with their contact details, in Section 2) worked so well together, and were steadfastly cheerful firstly in the face of the winch problems, and later in the face of the relentlessness of trawling and catch processing, is very much to their credit. As Principal Scientist on D243 I am extremely grateful for their hard work and support in the run-up to the cruise, during the time at sea, and in its aftermath. In particular I would like to single out for thanks Ben Boorman and Nigel Merrett who, as scientific day and night watch
leaders, ensured that the fishing and the supply of specimens continued without a break.
D243 was also notable for one other event: it was Peter Herringâ last cruise before his retirement from the Southampton Oceanography Centre. Without a doubt, none of the participants on D243 would have been there but for Peter, such has been his impact on ocean going biology. Indeed, the format of D243 very much follows the successful formula developed by him on numerous previous cruises, including some to the Cape Verde region of the West African upwelling. If a cruise report can be dedicated, this is dedicated to him
In-situ defect detection systems for R2R flexible PV barrier films
Film processing procedures by means of Roll-to-Roll (R2R) for barrier coatings can often result in PV barrier films being manufactured with significant quantities of defects, which resulting in lower efficiency and a short life span. In order to improve the process yield and product efficiency it is desirable to develop an inspection system that can detect transparent barrier film defects in the production line during the film processing. Off-line detection of defect in transparent PV barrier films is difficult and time consuming. Consequently implementing an accurate in-situ defects inspection system in the production environment is even more challenging, since the requirements on positioning, fast measurement, long term stability and robustness against environmental disturbance are demanding. This paper reports on the development and deployment of two in-situ PV barrier films defect detection systems, one of them is based on wavelength scanning interferometry (WSI) and the other one is based on White Light Channeled Spectral Interferometry (WLCSI), and the integration into an R2R film processing line in the Centre for Process Innovation (CPI). The paper outlines the environmental vibration strategy for both systems and the developed auto-focussing methodology for WSI. The systems have been tested and characterised and initial results compared to laboratory-based instrumentation are presented
In-situ defect detection systems for R2R flexible PV films
The atomic layer deposition technique (ALD) is
used to apply a thin (40-100 nm thick) barrier
coating of Al2O3 on polymer substrates for flexible
PV cells, to minimise and control the degradation
caused by water vapour ingress. However,
defects appearing on the film surfaces during the
Al2O3 ALD growth have been seen to be highly
significant in deterioration of the PV module
efficiency and lifespan [1]. In order to improve the
process yield and product efficiency, it is
desirable to develop an inspection system that
can detect transparent barrier film defects in the
production line during film processing. Off-line
detection of defects in transparent PV barrier
films is difficult and time consuming.
Consequently, implementing an accurate in-situ
defects inspection system in the production
environment is even more challenging, since the
requirements on positioning, fast measurement,
long term stability and robustness against
environmental disturbance are demanding. For
in-situ R2R defects inspection systems the
following conditions need to be satisfied by the
inspection tools. Firstly the measurement must
be fast and have no physical contact with the
inspected film surface. Secondly the
measurement system must be robust against the
environmental disturbance inspection. Finally the
system should have sub-micrometre lateral
resolution and nanometre vertical resolution in
order to be able to distinguish defects on the film
surface. Optical interferometry techniques have
the potentially to be used as a solution for such
application. However they are extremely sensitive
to environmental noise such as mechanical
vibration, air turbulence and temperature drift.
George [2] reported that a single shot
interferometry system âFlexCamâ developed by
4D Technology being used currently to detect
defects for PV barrier films manufactured by R2R
technology. It is robust against environmental
disturbances; but it has a limited vertical range,
which is restricted by the phase ambiguity of the
phase shift interferometry. This vertical
measurement range (a few hundreds
nanometres) is far less than the normal vertical
range of defects (a few micrometres up to a few
tens micrometres). It is not possible to detect the
majority of defects in the R2R flexible PV barrier
films
Researching education outcomes in Burundi, Malawi, Senegal and Uganda: using participatory tools and collaborative approaches : The Improving Learning Outcomes in Primary Schools (ILOPS) Project | Project methodology
In January 2008, ActionAid, Dr Karen Edge (IOE) and partners in Burundi, Malawi, Uganda and Senegal studied the role of parents and teachers in enhancing learning outcomes. The Improving Learning Outcomes in Primary Schools (ILOPS) Project was supported by the Quality Education in Developing Countries Initiative of the William and Flora Hewlett Foundation in partnership with the Bill & Melinda Gates Foundation. Findings from the ILOPS Project are presented in three separate briefs exploring teacher quality, parental participation and, this paper, exploring our tools and approaches. This paper, primarily designed for practitioner audiences, outlines the participatory research methodology designed by Dr Karen Edge and the strategies employ the methods with a team of 53 senior educational leaders from participating countries. The strategies were designed to bring teams of non-researchers together, to build national-level team capacity and collaboration and support their work in the field by collaborating with all participants to design the overall conceptual framework and methods of the study. In this paper, we provide details on the development and implementation of our approach as well as the lessons learned throughout the process for others interested in following similar approaches. This approach has been employed within several other IOE project, led by Dr Edge. In addition, the approach has influenced the work of ActionAid and other participating stakeholders
Quasi-hydrostatic intracluster gas under radiative cooling
Quasi-hydrostatic cooling of the intracluster gas is studied. In the
quasi-hydrostatic model, work done by gravity on the inflow gas with dP \neq 0,
where P is the gas pressure, is taken into account in the thermal balance. The
gas flows in from the outer part so as to compensate the pressure loss of the
gas undergoing radiative cooling, but the mass flow is so moderate and smooth
that the gas is considered to be quasi-hydrostatic. The temperature of the
cooling gas decreases toward the cluster center, but, unlike cooling flows with
dP = 0, approaches a constant temperature of \sim 1/3 the temperature of the
non-cooling ambient gas. This does not mean that gravitational work cancels out
radiative cooling, but means that the temperature of the cooling gas appears to
approach a constant value toward the cluster center if the gas maintains the
quasi-hydrostatic balance. We discuss the mass flow in quasi-hydrostatic
cooling, and compare it with the standard isobaric cooling flow model. We also
discuss the implication of \dot{M} for the standard cooling flow model.Comment: 5 pages, 1 figure, accepted for publication in A&
XMM-Newton Observation of a Distant X-ray Selected Cluster of Galaxies at z=1.26 with Possible Cluster Interaction
We report on the XMM-Newton (XMM) observation of RXJ1053.7+5735, one of the
most distant (z = 1.26) X-ray selected clusters of galaxies, which also shows
an unusual double-lobed X-ray morphology, indicative of possible
cluster-cluster interaction. The cluster was discovered during our ROSAT deep
pointings in the direction of the Lockman Hole. The XMM observations were
performed with the European Photon Imaging Camera (EPIC) during the performance
verification phase. Total effective exposure time was ~ 100 ksec. The best fit
temperature based on a simultaneous fit of spectra from the all EPIC cameras is
4.9(+1.5/-0.9) keV. Metallicity is poorly constrained even using the joint fit
of all spectra, with an upper limit on the iron abundance of 0.62 solar. Using
the best fit model parameters, we derived a bolometric luminosity of L(bol) =
3.4x10^44 h_{50}^-2 erg /s. Despite the fact that it was observed at fairly
large off-axis angle, the temperature errors are much smaller compared with
those of typical measurements based on ASCA or Beppo-Sax observations of z >
0.6 clusters, demonstrating the power of the XMM for determining the X-ray
temperature for high-z clusters. The measured temperature and luminosity show
that one can easily reach the intrinsically X-ray faint and cool cluster regime
comparable with those of z ~ 0.4 clusters observed by past satellites. The new
cluster temperature and L(bol) we have measured for RXJ1053.7+5735 is
consistent with a weak/no evolution of the L(bol) - Tx relation out to z ~ 1.3,
which lends support to a low Omega universe, although more data-points of z > 1
clusters are required for a more definitive statement. The caution has to be
also exercised in interpreting the result, because of the uncertainty
associated with the dynamical status of this cluster.Comment: Accepted for pubblication in A&A. 7 figures (One color figure is
changed to black and white.
Three-dimensional brain reconstruction of in vivo electrode tracks for neuroscience and neural prosthetic applications
The brain is a densely interconnected network that relies on populations of neurons within and across multiple nuclei to code for features leading to perception and action. However, the neurophysiology field is still dominated by the characterization of individual neurons, rather than simultaneous recordings across multiple regions, without consistent spatial reconstruction of their locations for comparisons across studies. There are sophisticated histological and imaging techniques for performing brain reconstructions. However, what is needed is a method that is relatively easy and inexpensive to implement in a typical neurophysiology lab and provides consistent identification of electrode locations to make it widely used for pooling data across studies and research groups. This paper presents our initial development of such an approach for reconstructing electrode tracks and site locations within the guinea pig inferior colliculus (IC) to identify its functional organization for frequency coding relevant for a new auditory midbrain implant (AMI). Encouragingly, the spatial error associated with different individuals reconstructing electrode tracks for the same midbrain was less than 65 ÎŒm, corresponding to an error of ~1.5% relative to the entire IC structure (~4â5 mm diameter sphere). Furthermore, the reconstructed frequency laminae of the IC were consistently aligned across three sampled midbrains, demonstrating the ability to use our method to combine location data across animals. Hopefully, through further improvements in our reconstruction method, it can be used as a standard protocol across neurophysiology labs to characterize neural data not only within the IC but also within other brain regions to help bridge the gap between cellular activity and network function. Clinically, correlating function with location within and across multiple brain regions can guide optimal placement of electrodes for the growing field of neural prosthetics
Particle acceleration in cooling flow clusters of galaxies: the case of Abell 2626
It has recently been proposed a theoretical model which accounts for the
origin of radio mini-halos observed in some cooling flow clusters as related to
electron re-acceleration by MHD turbulence (Gitti, Brunetti & Setti 2002). The
MHD turbulence is assumed to be frozen into the flow of the thermal ICM and
thus amplified in the cooling flow region. Here we present the application of
this model to a new mini-halo candidate, the cluster A2626, and compare the
results with those obtained for the mini-halo in the Perseus cluster. We
present VLA data at 330 MHz and 1.5 GHz of the diffuse radio emission observed
in A2626, and we show that its main properties can be explained by the model.
We find that the power necessary for the re-acceleration of the relic electron
population is only a factor ~ 0.7% of the maximum power that can be extracted
by the cooling flow (as estimated on the basis of the standard model). We also
discuss the observational properties of known mini-halos in connection with
those of host clusters, showing that the radio power of mini--halos increases
with the maximum power of cooling flows. This trend is expected in the
framework of the model. Possible effects of new Chandra and XMM-Newton
estimates of on this trend are considered: we conclude that even if
earlier derived cooling rates were overestimated, cooling flow powers are still
well above the radio powers emitted by mini-halos.Comment: 12 pages, 11 figures, accepted for publication in Astronomy &
Astrophysic
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