Med-Tech Innovation Products and Services
Tackling uneven moulding filling
activeFlowBalance is a software tool that combats uneven and fluctuating filling of multi-cavity moulds. It is available as an option on Sumitomo (SHI) Demag’s IntElect Smart all-electric machines and can be retrofitted to existing machines.
The technology balances filling ratios between mould cavities to counter complications such as flash formation, mould damage and under filling. In addition, it enables a reduction in clamp force by as much as 40%, reducing mould wear and delivering savings in energy consumption.
At the transition from injection to hold pressure, activeFlowBalance automatically starts to make use of the compression of the melt inside the barrel. At switch-over, the screw is held in a fixed position for a pre-selected time before reverting to the standard hold pressure setting, which is possible due to the drive and control systems offered by Sumitomo on its all electric machines. This results in partially filled cavities being filled by the expanding melt, with no additional pressure applied to already full cavities. As the pressure is allowed to stabilise across the system, material automatically flows into the cavities that are under- filled, producing a more even fill pattern. Single cavity moulds with uneven filling patterns or products with complex geometries can also benefit from this technology.
Sumitomo (SHI) Demag Tel. +44 (0)1296 739 500,
http://uk.sumitomo-shi-demag.eu
New materials for bone repair
Lucideon, a partner in the EU-funded Bio-Bone project (Bioceramics for Bone Repair) has announced that the consortium has developed phosphate-glasses (p-glasses) with biomaterial properties for bone repair. The company’s materials experts co-ordinated the biodegradation part of the EU project, which included a mixture of partners from academia and industry. Dr Martin Stefanic led the research at Lucideon, working on p-glasses and glass polymer composites for bone regeneration. Studies showed that p-glasses, which are used for bone implants, do not give the desired cell response, largely because of their fast degradation rate. The team focused on addressing the issue of p-glass stability by doping with various inorganic ions, which are known to affect the biological responses to the implants, and developing p-glasses with the appropriate physiochemical properties. Dr Stefanic said, “We have been successful in producing novel
strontium-doped p-glasses with superior properties, a development which will have a major impact on the next generation of implants. The new p-glasses we developed are now being tested for their biological effect by a cutting edge institution. Our findings have truly opened the door for future applications in bone implants.”
www.med-techinnovation.com
Lucideon, a provider of materials development, testing and assurance, has also recently invested more than £1 million in establishing new wear testing facilities in the UK and USA to provide a more comprehensive portfolio of services to the orthopaedic implant industry. Lucideon Tel. +44 (0)1782 764 428,
www.lucideon.com
Achieving well design clinical trials
Factory CRO has developed a new early detection programme to help medical device companies correct poorly designed clinical trials, which can save the study from being rejected by FDA or European regulators. Fundamental issues such as making faulty business or medical assumptions or overly strict inclusion–exclusion criteria can derail a clinical trial from the start. Poorly written protocols that are not CFR, GCP or ISO-14155 compliant also set the stage for clinical trial failure. The medical device clinical research organisation has developed a
rescue assessment programme that can be implemented in as little as three weeks. It includes an audit of the collected data, discussions with senior management about study objectives, a review of protocols to identify trouble areas related to enrollment and regulatory compliance, and expert advice on a recovery plan. Finally, it can assist with the implementation of the rescue plan. Factory-CRO Tel. +31 30 229 2727,
www.factory-cro.com
Mobile cleanroom unit
Connect 2 Cleanrooms has launched a mobile, adjustable cleanroom unit that can be fitted at critical points in the manufacturing process line. It promises to minimise the cost of manufacturing medical devices and their packaging to GMP air standards. HEPA-lite provides localised
filtered air to protect processes from contamination, without the need to enclose the entire machine set-up within a cleanroom environment. The modular system has low, braked castors and angle-adjustable legs to make it easy to slide under machinery and the C-frame itself is built bespoke to requirements. Its minimal footprint makes it ideal for work areas where space is at a premium. The company’s Managing Director, Joe Govier, explained, “Firms which manufacturer medical devices can be faced with huge time and cost implications to ensure their production line meets the standards of ISO 14644-1 or a Class 5-9 environment. “Not only is the product adaptable and efficient, it is economical. By maintaining the quality of air at points on the production line where the product is exposed, it means there is no need for the entire machinery to be placed within a traditional
September/October 2014 ¦ 37
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