Quality control of pharmaceutical ingredients:developing a caking test for industry

Objectives - Powdered and granulated particulate materials make up most of the ingredients of pharmaceuticals and are often at risk of undergoing unwanted agglomeration, or caking, during transport or storage. This is particularly acute when bulk powders are exposed to extreme swings in temperature and relative humidity, which is now common as drugs are produced and administered in increasingly hostile climates and are stored for longer periods of time prior to use. This study explores the possibility of using a uniaxial unconfined compression test to compare the strength of caked agglomerates exposed to different temperatures and relative humidities. This is part of a longer-term study to construct a protocol to predict the caking tendency of a new bulk material from individual particle properties. The main challenge is to develop techniques that provide repeatable results yet are presented simply enough to be useful to a wide range of industries. Methods - Powdered sucrose, a major pharmaceutical ingredient, was poured into a split die and exposed to high and low relative humidity cycles at room temperature. The typical ranges were 20–30% for the lower value and 70–80% for the higher value. The outer die casing was then removed and the resultant agglomerate was subjected to an unconfined compression test using a plunger fitted to a Zwick compression tester. The force against displacement was logged so that the dynamics of failure as well as the failure load of the sample could be recorded. The experimental matrix included varying the number of cycles, the amount between the maximum and minimum relative humidity, the height and diameters of the samples, the number of cycles and the particle size. Results - Trends showed that the tensile strength of the agglomerates increased with the number of cycles and also with the more extreme swings in relative humidity. This agrees with previous work on alternative methods of measuring the tensile strength of sugar agglomerates formed from humidity cycling (Leaper et al 2003). Conclusions - The results show that at the very least the uniaxial tester is a good comparative tester to examine the caking tendency of powdered materials, with a simple arrangement and operation that are compatible with the requirements of industry. However, further work is required to continue to optimize the height/ diameter ratio during tests.

Quality control in Midland industry

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Development of a quality control material for the measurement of 8-oxo-7,8-dihydro-2'-deoxyguanosine, an in vivo marker of oxidative stress, and comparison of results from different laboratories

The measurement of 8-oxo-7,8-dihydro-2'-deoxyguanosine is an increasingly popular marker of in vivo oxidative damage to DNA. A random-sequence 21-mer oligonucleotide 5'-TCA GXC GTA CGT GAT CTC AGT-3' in which X was 8-oxo-guanine (8-oxo-G) was purified and accurate determination of the oxidised base was confirmed by a 32P-end labelling strategy. The lyophilised material was analysed for its absolute content of 8-oxo-dG by several major laboratories in Europe and one in Japan. Most laboratories using HPLC-ECD underestimated, while GC-MS-SIM overestimated the level of the lesion. HPLC-ECD measured the target value with greatest accuracy. The results also suggest that none of the procedures can accurately quantitate levels of 1 in 10(6) 8-oxo-(d)G in DNA.

Egg quality and fecundity in rainbow trout: the determining factors and mechanisms of control

This thesis considers the factors involved in the determination of egg quality and fecundity in farmed stocks of rainbow trout ( Salmo gairdneri R) • Measurements of egg quality, ie. percentage survivals of eggs and fry, from the production batches of eggs of seven fish farms, showed mean survivals of 70% to eying but levels of only 35% to 4.5g fry (approx. 130 days post-fertilisation). Under optimum conditions survivals may reach 85% suggesting that husbandry methods exert significant influences on egg quality. Chemical analyses of the protein, fat, vitellogenin, ash, amino acids, free fatty acid and mineral levels of eggs of varying quality and from parents of different strains showed compositional differences even between individuals of the same stock. However, none of these differences were correlated with egg quality. Egg size showed similar variations but, again under hatchery conditions there was no correlation with differences in egg quality. The only factor which has been shown to exert a significant influence on egg quality is the time of stripping after ovulation. At 1 0°C eggs should be removed from gravid females within ten days of ovulation to achieve optimum egg and fry survival. Studies of egg production from approximately 10,000 broodstock revealed that total fecundity and egg size increased and relative fecundity decreased with increasing fish size. In general, most fish appeared to produce a constant volume of eggs. This is consistent with a hypothesis that egg size can only be increased by parallel reductions in fecundity. Feeding broodstock at half-ration (0.35% body weight day- 1 ) did not affect egg quality but reduced total fecundity and egg size and increased relative fecundity when compared with eggs produced by fish on full-ration. Comparisons of regressions of total fecundity against fish weight for three strains using ANOCO revealed that one strain was significantly more fecund than two other strains considered. Trout of the same strain maintained on different farms behaved similarly suggesting there was some reproducibility of strain characteristics.

QoS guarantee with adaptive transmit power and message rate control for DSRC vehicle network based road safety applications

Quality of services (QoS) support is critical for dedicated short range communications (DSRC) vehicle networks based collaborative road safety applications. In this paper we propose an adaptive power and message rate control method for DSRC vehicle networks at road intersections. The design objective is to provide high availability and low latency channels for high priority emergency safety applications while maximizing channel utilization for low priority routine safety applications. In this method an offline simulation based approach is used to find out the best possible configurations of transmit power and message rate for given numbers of vehicles in the network. The identified best configurations are then used online by roadside access points (AP) according to estimated number of vehicles. Simulation results show that this adaptive method significantly outperforms a fixed control method. © 2011 Springer-Verlag.

Rethinking policy options for industry:Appropriateness of policies for industry and UK farming and food

Purpose - Studies the implementation of lean supply and partnership relationships in the UK food and farming industry to assess if these types of interventions are effective. Design/methodology/approach - Reviews the challenges affecting the UK supply chain for red meat. Describes the initiatives that were set up to develop a lean supply chain management approach and examines their application in the UK pig and beef industries. Assesses if these changes benefited all participants in the supply chains. Uses semi-structured interviews with key actors in each stage of the supply chain to do this, identifying the power relations within the supply chains and how these affected the outcomes for those participating in the chain. Findings - Concludes that lean initiatives were appropriate for the pig industry but were of limited value for the beef industry. Even within the pig industry, highlights that benefits were not shared equally, with producers, in particular, losing out. Lastly, points out that lean supply chain management is unlikely to be appropriate operationally and commercially in all circumstances in one industry. Argues for a differentiated policy approach and sets out a framework which enables decision makers to select industrial policy options. Research limitations/ implications - Describes the analysis and the framework developed from it. Originality/value - Assesses the effectiveness of lean supply chain management.

Governance of open content creation:a conceptualization and analysis of control and guiding mechanisms in the open content domain

The open content creation process has proven itself to be a powerful and influential way of developing text-based content, as demonstrated by the success of Wikipedia and related sites. Distributed individuals independently edit, revise, or refine content, thereby creating knowledge artifacts of considerable breadth and quality. Our study explores the mechanisms that control and guide the content creation process and develops an understanding of open content governance. The repertory grid method is employed to systematically capture the experiences of individuals involved in the open content creation process and to determine the relative importance of the diverse control and guiding mechanisms. Our findings illustrate the important control and guiding mechanisms and highlight the multifaceted nature of open content governance. A range of governance mechanisms is discussed with regard to the varied levels of formality, the different loci of authority, and the diverse interaction environments involved. Limitations and opportunities for future research are provided.

Quality control of high throughput screening

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Quality control of high throughput screening

DUE TO COPYRIGHT RESTRICTIONS ONLY AVAILABLE FOR CONSULTATION AT ASTON UNIVERSITY LIBRARY AND INFORMATION SERVICES WITH PRIOR ARRANGEMENT

Design and evaluation of a framework for cooperative and adaptive QoS control of DSRC network for road safety applications

Dedicated short-range communications (DSRC) are a promising vehicle communication technique for collaborative road safety applications (CSA). However, road safety applications require highly reliable and timely wireless communications, which present big challenges to DSRC based vehicle networks on effective and robust quality of services (QoS) provisioning due to the random channel access method applied in the DSRC technique. In this paper we examine the QoS control problem for CSA in the DSRC based vehicle networks and presented an overview of the research work towards the QoS control problem. After an analysis of the system application requirements and the DSRC vehicle network features, we propose a framework for cooperative and adaptive QoS control, which is believed to be a key for the success of DSRC on supporting effective collaborative road safety applications. A core design in the proposed QoS control framework is that network feedback and cross-layer design are employed to collaboratively achieve targeted QoS. A design example of cooperative and adaptive rate control scheme is implemented and evaluated, with objective of illustrating the key ideas in the framework. Simulation results demonstrate the effectiveness of proposed rate control schemes in providing highly available and reliable channel for emergency safety messages. © 2013 Wenyang Guan et al.

Achieving low cost and high quality aero structure assembly through integrated digital metrology systems

Measurement assisted assembly (MAA) has the potential to facilitate a step change in assembly efficiency for large structures such as airframes through the reduction of rework, manually intensive processes and expensive monolithic assembly tooling. It is shown how MAA can enable rapid part-to-part assembly, increased use of flexible automation, traceable quality assurance and control, reduced structure weight and improved aerodynamic tolerances. These advances will require the development of automated networks of measurement instruments; model based thermal compensation, the automatic integration of 'live' measurement data into variation simulation and algorithms to generate cutting paths for predictive shimming and drilling processes. This paper sets out an architecture for digital systems which will enable this integrated approach to variation management. © 2013 The Authors.

VGI quality control

This paper presents a framework for considering quality control of volunteered geographic information (VGI). Different issues need to be considered during the conception, acquisition and post-acquisition phases of VGI creation. This includes items such as collecting metadata on the volunteer, providing suitable training, giving corrective feedback during the mapping process and use of control data, among others. Two examples of VGI data collection are then considered with respect to this quality control framework, i.e. VGI data collection by National Mapping Agencies and by the most recent Geo-Wiki tool, a game called Cropland Capture. Although good practices are beginning to emerge, there is still the need for the development and sharing of best practice, especially if VGI is to be integrated with authoritative map products or used for calibration and/or validation of land cover in the future.