Fiber bragg gratings:advances in fabrication process and tools

Successful commercialization of a technology such as Fiber Bragg Gratings requires the ability to manufacture devices repeatably, quickly and at low cost. Although the first report of photorefractive gratings was in 1978 it was not until 1993, when phase mask fabrication was demonstrated, that this became feasible. More recently, draw tower fabrication on a production level and grating writing through the polymer jacket have been realized; both important developments since they preserve the intrinsic strength of the fiber. Potentially the most significant recent development has been femtosecond laser inscription of gratings. Although not yet a commercial technology, it provides the means of writing multiple gratings in the optical core providing directional sensing capability in a single fiber. Femtosecond processing can also be used to machine the fiber to produce micronscale slots and holes enhancing the interaction between the light in the core and the surrounding medium. © 2011 Bentham Science Publishers Ltd. All rights reserved.

Composite cell support membranes based on collagen and polycaprolactone for tissue engineering of skin

The preparation and characterisation of collagen:PCL composites for manufacture of tissue engineered skin substitutes and models are reported. Films having collagen:PCL (w/w) ratios of 1:4, 1:8 and 1:20 were prepared by impregnation of lyophilised collagen mats by PCL solutions followed by solvent evaporation. In vitro assays of collagen release and residual collagen content revealed an expected inverse relationship between the collagen release rate and the content of synthetic polymer in the composite that may be exploited for controlled presentation and release of biopharmaceuticals such as growth factors. DSC analysis revealed the characteristic melting point of PCL at around 60°C and a tendency for the collagen component, at high loading, to impede crystallinity development within the PCL phase. The preparation of fibroblast/composite constructs was investigated using cell culture as a first stage in mimicking the dermal/epidermal structure of skin. Fibroblasts were found to attach and proliferate on all the composites investigated reaching a maximum of 2×105/cm2 on 1:20 collagen:PCL materials at day 8 with cell numbers declining thereafter. Keratinocyte growth rates were similar on all types of collagen:PCL materials investigated reaching a maximum of 6.6×104/cm2 at day 6. The results revealed that composite films of collagen and PCL are favourable substrates for growth of fibroblasts and keratinocytes and may find utility for skin repair. © 2003 Elsevier Ltd. All rights reserved.

Challenges and emerging solutions in the development of compressed orally disintegrating tablets

Areas covered: The review discusses the main challenges of ODT manufacturing process and the emerging solutions featured at early drug development stages. The research specifically describes the methods reported for taste masking/assessment and solubilisation of unpalatable and poorly soluble drugs, respectively. Furthermore, this review highlights the techniques used for developing modified-release ODTs, an emerging area in the field. In addition, it also discusses the poor flowability and segregation problems of directly compressed powders. Moreover, the review describes the tests reported in the literature for ODT disintegration time assessment since a universal technique is still non-existent. Expert opinion: The approaches used to overcome the manufacturing challenges often have a bearing on the price of the end product. However, despite the technical and regulatory challenges, ODTs can offer many advantages over the conventional dosage forms if accompanied by suitable adjuvant technologies and in vitro analytical tools. © 2014 Informa UK, Ltd. Introduction: Orally disintegrating tablets (ODTs) provide several advantages over conventional tablets such as suitability for patients with swallowing difficulties and faster onset of action. The manufacture of ODTs by compression/tableting offers a practical and cost-effective strategy over the freeze drying (lyophilisation) method. Nonetheless, the FDA recommends a disintegration time of 30 s and a maximum weight of 500 mg for a tablet to be labelled as an ODT. These requirements, alongside other desirable product properties, have created a number of challenges for the formulator to overcome while developing compressed ODTs.

Catalysing sustainable fuel and chemical synthesis

Concerns over the economics of proven fossil fuel reserves, in concert with government and public acceptance of the anthropogenic origin of rising CO2 emissions and associated climate change from such combustible carbon, are driving academic and commercial research into new sustainable routes to fuel and chemicals. The quest for such sustainable resources to meet the demands of a rapidly rising global population represents one of this century’s grand challenges. Here, we discuss catalytic solutions to the clean synthesis of biodiesel, the most readily implemented and low cost, alternative source of transportation fuels, and oxygenated organic molecules for the manufacture of fine and speciality chemicals to meet future societal demands.

Exploring the digital supply chain:implications and models for online software distribution

As a discipline, supply chain management (SCM) has traditionally been primarily concerned with the procurement, processing, movement and sale of physical goods. However an important class of products has emerged - digital products - which cannot be described as physical as they do not obey commonly understood physical laws. They do not possess mass or volume, and they require no energy in their manufacture or distribution. With the Internet, they can be distributed at speeds unimaginable in the physical world, and every copy produced is a 100% perfect duplicate of the original version. Furthermore, the ease with which digital products can be replicated has few analogues in the physical world. This paper assesses the effect of non-physicality on one such product – software – in relation to the practice of SCM. It explores the challenges that arise when managing the software supply chain and how practitioners are addressing these challenges. Using a two-pronged exploratory approach that examines the literature around software management as well as direct interviews with software distribution practitioners, a number of key challenges associated with software supply chains are uncovered, along with responses to these challenges. This paper proposes a new model for software supply chains that takes into account the non-physicality of the product being delivered. Central to this model is the replacement of physical flows with flows of intellectual property, the growing importance of innovation over duplication and the increased centrality of the customer in the entire process. Hybrid physical / digital supply chains are discussed and a framework for practitioners concerned with software supply chains is presented.

Diversifying into technical clothing manufacture as entrepreneurial learning:a situated learning theory perspective

Purpose - The purpose of this paper is to demonstrate analytically how entrepreneurial action as learning relating to diversifying into technical clothing - i.e. a high-value manufacturing sector - can take place. This is particularly relevant to recent discussion and debate in academic and policy-making circles concerning the survival of the clothing manufacture industry in developed industrialised countries. Design/methodology/approach - Using situated learning theory (SLT) as the major analytical lens, this case study examines an episode of entrepreneurial action relating to diversification into a high-value manufacturing sector. It is considered on instrumentality grounds, revealing wider tendencies in the management of knowledge and capabilities requisite for effective entrepreneurial action of this kind. Findings - Boundary events, brokers, boundary objects, membership structures and inclusive participation that addresses power asymmetries are found to be crucial organisational design elements, enabling the development of inter- and intracommunal capacities. These together constitute a dynamic learning capability, which underpins entrepreneurial action, such as diversification into high-value manufacturing sectors. Originality/value - Through a refinement of SLT in the context of entrepreneurial action, the paper contributes to an advancement of a substantive theory of managing technological knowledge and capabilities for effective diversification into high-value manufacturing sectors. Copyright © 2014 Emerald Group Publishing Limited. All rights reserved.

Excipient characterization and particle engineering to develop directly compressed orally disintegrating tablets

ODTs have emerged as a novel oral dosage form with a potential to deliver a wide range of drug candidates to paediatric and geriatric patients. Compression of excipients offers a costeffective and translatable methodology for the manufacture of ODTs. Though, technical challenges prevail such as difficulty to achieve suitable tablet mechanical strength while ensuring rapid disintegration in the mouth, poor compressibility of preferred ODT diluent Dmannitol, and limited use for modified drug-release. The work investigates excipients’ functionality in ODTs and proposes new methodologies for enhancing material characteristics via process and particle engineering. It also aims to expand ODT applications for modified drug-release. Preformulation and formulation studies employed a plethora of techniques/tests including AFM, SEM, DSC, XRD, TGA, HSM, FTIR, hardness, disintegration time, friability, stress/strain and Heckel analysis. Tableting of D-mannitol and cellulosic excipients utilised various compression forces, material concentrations and grades. Engineered D-mannitol particles were made by spray drying mannitol with pore former NH4HCO3. Coated microparticles of model API omeprazole were prepared using water-based film forming polymers. The results of nanoscopic investigations elucidated the compression profiles of ODT excipients. Strong densification of MCC (Py is 625 MPa) occurs due to conglomeration of physicomechanical factors whereas D-mannitol fragments under pressure leading to poor compacts. Addition of cellulosic excipients (L-HPC and HPMC) and granular mannitol to powder mannitol was required to mechanically strengthen the dosage form (hardness >60 N, friability <1%) and to maintain rapid disintegration (<30 sec). Similarly, functionality was integrated into D-mannitol by fabrication of porous, yet, resilient particles which resulted in upto 150% increase in the hardness of compacts. The formulated particles provided resistance to fracture under pressure due to inherent elasticity while promoted tablet disintegration (50-77% reduction in disintegration time) due to porous nature. Additionally, coated microparticles provided an ODT-appropriate modified-release coating strategy by preventing drug (omeprazole) release.

Microfluidic-controlled manufacture of liposomes for the solubilisation of a poorly water soluble drug

Besides their well-described use as delivery systems for water-soluble drugs, liposomes have the ability to act as a solubilizing agent for drugs with low aqueous solubility. However, a key limitation in exploiting liposome technology is the availability of scalable, low-cost production methods for the preparation of liposomes. Here we describe a new method, using microfluidics, to prepare liposomal solubilising systems which can incorporate low solubility drugs (in this case propofol). The setup, based on a chaotic advection micromixer, showed high drug loading (41 mol%) of propofol as well as the ability to manufacture vesicles with at prescribed sizes (between 50 and 450 nm) in a high-throughput setting. Our results demonstrate the ability of merging liposome manufacturing and drug encapsulation in a single process step, leading to an overall reduced process time. These studies emphasise the flexibility and ease of applying lab-on-a-chip microfluidics for the solubilisation of poorly water-soluble drugs.

The translation of cell-based therapies:clinical landscape and manufacturing challenges

Cell-based therapies have the potential to make a large contribution toward currently unmet patient need and thus effective manufacture of these products is essential. Many challenges must be overcome before this can become a reality and a better definition of the manufacturing requirements for cell-based products must be obtained. The aim of this study is to inform industry and academia of current cell-based therapy clinical development and to identify gaps in their manufacturing requirements. A total of 1342 active cell-based therapy clinical trials have been identified and characterized based on cell type, target indication and trial phase. Multiple technologies have been assessed for the manufacture of these cell types in order to facilitate product translation and future process development.

Precision emulsification for droplet and capsule production

Emulsions and microcapsules are typical structures in various dispersion formulations for pharmaceutical, food, personal and house care applications. Precise control over size and size distribution of emulsion droplets and microcapsules are important for effective use and delivery of active components and better product quality. Many emulsification technologies have been developed to meet different formulation and processing requirements. Among them, membrane and microfluidic emulsification as emerging technologies have the feature of being able to precisely manufacture droplets in a drop-by-drop manner to give subscribed sizes and size distributions with lower energy consumption. This paper reviews fundamental sciences and engineering aspects of emulsification, membrane and microfluidic emulsification technologies and their use for precision manufacture of emulsions for intensified processing. Generic application examples are given for single and double emulsions and microcapsules with different structure features. © 2013 The Society of Powder Technology Japan. Published by Elsevier B.V.

Excipients in medicines for children:scientific and regulatory paradigms

There is an ongoing debate over the use of pharmaceutical excipients in medicines for children, triggered by the increased number of formulations suitable for this target patient population. Pharmaceutical excipients can be regarded as essential / necessary enablers in formulation development. These are materials other than the 'active pharmaceutical ingredient' which are added to the formulation to achieve a specific function1. This may include aiding in the processing or manufacture of the drug delivery system such as lubricants or flow aids, controlling the release of the active ingredient to achieve modified release, enhance patient acceptability by improving taste of medicines or to develop easily swallowed dosage forms.

Influence of processing and clay type on nanostructure and stability of polypropylene-clay nanocomposites

Melt processing is a critical step in the manufacture of polymer articles and is even more critical when dealing with inhomogeneous polymer-clay nanocomposites systems. The chemical composition, and in particular the clay type and its organic modification, also plays a major contribution in determining the final properties and in particular the thermal and long-term oxidative stability of the resulting polymer nanocomposites. Proper selection and tuning of the process variable should, in principle, lead to improved characteristics of the fabricated product. With multiphase systems containing inorganic nanoclays, however, this is not straightforward and it is often the case that the process conditions are chosen initially to improve one or more desired properties at the expense of others. This study assesses the influence of organo-modified clays and the processing parameters (extrusion temperature and screw speed) on the rheological and morphological characteristics of polymer nanocomposites as well as on their melt and thermo-oxidative stability. Nanocomposites (PPNCs) based on PP, maleated PP and organically modified clays were prepared in different co-rotating twin-screw extruders ranging from laboratory scale to semi-industrial scale. Results show that the amount of surfactant present in similar organo-modified clays affects differently the thermo-oxidative stability of the extruded PPNCs and that changes in processing conditions affect the clay morphology too. By choosing an appropriate set of tuned process variables for the extrusion process it would be feasible to selectively fabricate polymer-clay nanocomposites, with the desired mechanical and thermo-oxidative characteristics. © 2013 Elsevier Ltd. All rights reserved.

Bio-based chemicals from biorefining:carbohydrate conversion and utilisation

The quest for sustainable sources of fuels and chemicals to meet the demands of a rapidly rising global population represents one of this century's grand challenges. Biomass offers the most readily implemented, and low cost, solution for transportation fuels, and the only non-petroleum route to organic molecules for the manufacture of bulk, fine and speciality chemicals and polymers. Chemical processing of such biomass-derived building blocks requires catalysts compatible with hydrophilic, bulky substrates to facilitate the selective deoxygenation of highly functional bio-molecules to their target products. This chapter addresses the challenges associated with carbohydrate utilisation as a sustainable feedstock, highlighting innovations in catalyst and process design that are needed to deliver high-value chemicals from biomass-derived building blocks. © 2014 Woodhead Publishing Limited. All rights reserved.

Review of industrial temperature measurement technologies and research priorities for the thermal characterisation of the factories of the future

As the largest source of dimensional measurement uncertainty, addressing the challenges of thermal variation is vital to ensure product and equipment integrity in the factories of the future. While it is possible to closely control room temperature, this is often not practical or economical to realise in all cases where inspection is required. This article reviews recent progress and trends in seven key commercially available industrial temperature measurement sensor technologies primarily in the range of 0 °C–50 °C for invasive, semi-invasive and non-invasive measurement. These sensors will ultimately be used to measure and model thermal variation in the assembly, test and integration environment. The intended applications for these technologies are presented alongside some consideration of measurement uncertainty requirements with regard to the thermal expansion of common materials. Research priorities are identified and discussed for each of the technologies as well as temperature measurement at large. Future developments are briefly discussed to provide some insight into which direction the development and application of temperature measurement technologies are likely to head.

A hybrid measurement systems analysis and uncertainty of measurement approach for industrial measurement in the light controlled factory

The uncertainty of measurements must be quantified and considered in order to prove conformance with specifications and make other meaningful comparisons based on measurements. While there is a consistent methodology for the evaluation and expression of uncertainty within the metrology community industry frequently uses the alternative Measurement Systems Analysis methodology. This paper sets out to clarify the differences between uncertainty evaluation and MSA and presents a novel hybrid methodology for industrial measurement which enables a correct evaluation of measurement uncertainty while utilising the practical tools of MSA. In particular the use of Gage R&R ANOVA and Attribute Gage studies within a wider uncertainty evaluation framework is described. This enables in-line measurement data to be used to establish repeatability and reproducibility, without time consuming repeatability studies being carried out, while maintaining a complete consideration of all sources of uncertainty and therefore enabling conformance to be proven with a stated level of confidence. Such a rigorous approach to product verification will become increasingly important in the era of the Light Controlled Factory with metrology acting as the driving force to achieve the right first time and highly automated manufacture of high value large scale products such as aircraft, spacecraft and renewable power generation structures.