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  • The Effects of Particle Size Distribution on the Properties of Medical Materials

    As so many 3-D products are created from powder particles, the shape and size of these particulates can have a great impact on the physical and chemical properties of the final product. Analysis of the size distribution and shape of the particles can also give useful information concerning the processes they go through in manufacturing, and can help make these processes more efficient as well as, of course, helping to solve problems. This is of particular importance in the field of medical materials and devices, as processing control for materials that enter the body is vital. This white paper will discuss laser diffraction, a well-known method for measuring particle size distribution (PSD). As well as describing the theory behind it, the paper will focus on how important laser diffraction can be to the field of medical materials.

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  • The Role of Zeta Potential in the Manufacture of Healthcare Materials

    In the manufacture of healthcare products and medical materials, especially ceramic materials like zirconia (used as an implant material) and hydroxyapatite (synthetic bone replacement material), there is often a stage in the manufacturing process involving a powder suspension. The behaviour of this powder suspension will correlate strongly to (a) how well it is processed and therefore (b) final yields and product performance. Surface chemistry dominates the particle-particle interactions in suspension, with different materials having different surface charges. These interactions in turn dictate suspension rheology. Zeta potential is used to investigate and monitor the surface interactions in powder suspensions, and can also be used to optimise the processing method. In a previous white paper, 'The Applications of Zeta Potential in Process Control', the in-depth theory of zeta potential was presented and discussed. This white paper will discuss its applications for the manufacture of certain healthcare materials and how Lucideon has assisted manufacturers in this area.

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  • The Applications of Zeta Potential in Process Control

    Powders play a very important role in many different areas of healthcare, most importantly in dentistry and orthopaedic materials, where they become either coatings or 3D structures. As many powder materials exist as suspensions in the early stages of their manufacturing, powder surface chemistry (and associated charge) can strongly influence suspensions’ rheological properties, and so the quality of subsequent processing. This can have dramatic effects on the quality of any end products and can lead to failure of these products. Given that powder surface charge is so critical, zeta potential becomes a crucial measurement for characterising and then optimising suspension behaviour. Zeta potential is essentially the energy required to shear a particle and associated ions away from a bulk solution. From these values, the stability of the system can be established: whether the particles are well dispersed and stable, or flocculated and unstable. This paper will discuss the theory of zeta potential, and how it can be measured and controlled. The particular advantages of using the ZetaProbe® apparatus available at Lucideon will also be discussed.

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  • Regulatory Approval Testing of Hydroxyapatite - The Benefits of Using One Supplier

    Gaining and maintaining regulatory approval of medical devices and materials, such as Hydroxyapatite (HA) can be a fraught, lengthy and complex process. Submission of data to regulatory bodies, for example the FDA (Food and Drug Administration), has to be credible and fully documented in order to ensure success. Post-regulatory approval testing is also important, not only to confirm that regulatory standards are continuing to be kept but also that consistency, quality and performance are being maintained.
    In this white paper, Gemma Budd, Product Manager – Healthcare at Lucideon, argues the case for using one supplier for regulatory approval testing, using the example of HA testing.

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  • Synthesis Method of Hydroxyapatite

    Due to the ageing UK population, increased dynamism of people's lives and growing life expectancy, there is an increasing clinical demand for bone replacement and repair. The main mineral component of bone tissue is a nonstoichiometric carbonated multi-substituted apatite with calcium to phosphorus ratio (Ca:P) between 1.37 and 1.87. Synthetic hydroxyapatite is a popular bone replacement material because it has a similar crystal structure (Ca:P ratio fixed at 1.67) to native bone apatite. This resemblance is the origin of the excellent compatibility that HA exhibits with hard tissue and its natural bioactive behaviour; enabling it to be incorporated into the body via the same processes active in the remodelling of healthy bone.

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  • Polymer Basics: Structure & Properties

    Although polymers have been the most widely used material in the pharmaceutical and medical devices industry for many years, they are still often the root cause of many problems, such as unexpected product failure or yield deterioration. This is usually down to the complexity of polymeric materials. Chemical and physical structure can change at any stage - during manufacturing, post treatment (e.g. during sterilization), in storage, transportation or in use. The resulting changes in structure, which can range from the nano and micro up to millimetre scales, consequently affect the performance of the product. What’s more, product failures are often due to several co-existing factors. It is important, therefore, to understand the factors that can affect a polymer’s structure and, hence, its properties.
    This paper will introduce the basic concepts regarding the structure and properties of polymeric materials. It will be of particular interest to engineers, technologists, scientists, technical managers and QA/QC professionals; anyone who is involved in developing new products or finding root causes of failures.

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  • Siloxanes in Biogas and Landfill Gas - The Benefits of GC-MS Analysis for Combined Heat and Power Gas Processes

    The waste feedstock used to generate biogas and landfill gas (LFG) often produces siloxanes; silicon-based organic materials which are widely used in industry, e.g. water repellents, cosmetics, deodorants and shampoos. Siloxanes become a significant problem when combusted in combined heat and power (CHP) gas engines; they form silicon dioxide, an abrasive glass-like material which can damage the engines.
    Gas Chromatography-Mass Spectroscopy (GC-MS) can analyse for these compounds, confirm the identity of the siloxane and provide information on other contaminants within the gas. Alternative analysis techniques such as Gas Chromatography- Flame Ionisation Detection (GC-FID), Inductively Coupled Plasma (ICP), Fourier Transform Infrared (FTIR) and Gas Chromatography-Atomic Emissions Spectroscopy (GC-AES), are unable to provide this information. On-line FTIR is becoming more prominent as an in-situ analysis method; nevertheless this technique is limited both in detection limits and specificity. This on-line technique can only identify the Si=O bond, and is unable to differentiate between the different linear siloxanes or the different cyclic siloxanes; the results are reported as either total linear or total cyclic siloxanes.

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  • Multi-Substituted Hydroxyapatites & Their Role in Bone Replacement

    Much research has been done into developing synthetic Hydroxyapatite (HA) as materials for bone replacement, due to the fact that natural bone comprises HA. In addition, HA powders have been used as coatings on metal implants in a bid to make them more compatible with the body and to promote stronger bone-to-implant bonding and hence increased longevity of the implant (for example, in the case of femoral hip implants). This paper explores the role of (multi-element) substitution in HA and how this can impact on behaviour of HA in aqueous physiological environments.

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  • Driving Up Profits and Reducing Emissions: The Benefits of ISO 50001

    Climate Change is the global environmental issue that will effect everybody and the major cause is the carbon dioxide produced as a result of burning fossil fuels. Energy efficiency is the obvious and often the lowest cost route to reducing emissions. Energy prices in the UK have doubled in the past decade hitting the profitability of every business. The new energy management standard ISO 50001 provides a systematic approach to measuring, monitoring and reducing energy consumption in any organisation. Modelled on the ‘Plan Do Check Act’ cycle, ISO 50001 has much in common with other standards such as ISO 140001 (environmental management) and ISO 9001 (quality management) and early adopters have typically reported energy savings of 25%.

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  • Calculating a Water Footprint - The Benefits for Your Business

    Water supplies in many parts of the world are classified as ‘stressed’ where demand exceeds the resources available. Although this issue is usually associated with heavily populated regions with limited rainfall, it is also becoming increasingly common in areas where rainfall is relatively plentiful, particularly in developing nations where rising and increasingly urban populations combine with economic growth to create huge water demands from industry and agriculture.
    Many European counties, and some regions of the UK already have water supplies that are classified as stressed; areas of south and south east England have lower rainfall per capita than many Mediterranean countries.
    This paper explains why water is unlikely to be regarded as it is today, a cheap and freely available resource; prices will increase and restrictions may be imposed in some parts of the UK.

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