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Covering news and technical
developments in the pharmaceutical industry
Innovations seminar for Singapore
US. K-Tron Process Group has announced its collaboration with Leistritz, Fitzpatrick, Howorth Air Technology, Premier Pneumatics and Russell Finex, presenting a complimentary technical seminar, entitled Innovations in pharmaceutical processing , in Singapore on 22 October 2008. The
seminar will provide detailed process and analytical information about key topics and trends, including the latest developments in continuous feeding and dispensing, extrusion, granulation, hot melt extrusion, high containment solutions, contained size reduction, agglomeration, pneumatic conveying, screening and sieving.
It aims to offer an objective technical overview and introduce participants to methods of improving current operations and utilising new technologies. Course material is suitable for scientists, engineers, production and manufacturing personnel, researchers, formulation scientists, product development and process transfer personnel.
www.ktron.com/seminar
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10:16 04/08/2008
Brochure for pharmaceutical/nutraceutical processors
USA. K-Tron Process Group (K-Tron Feeders and Premier Pneumatics) has a new brochure that provides an in-depth look at process applications and equipment for feeding and pneumatically conveying bulk materials in the pharmaceutical and nutraceutical industries. It offers information about the company’s system expertise including design and integration of Premier Pneumatics sanitary receivers with K-Tron pharmaceutical feeders and micro-ingredient feeders. As the pharmaceutical sector gravitates from batch to continuous processing, K-Tron continues to be at the forefront of sanitary feeding and material handling equipment. The brochure provides information about the company’s expertise, including feeding and conveying in tablet press operations and complete system integration.
Typical feeding principles relating to volumetric and loss-in-weight gravimetric feeding are highlighted and there is an in-depth look at pharmaceutical feeder design and models available. An overview of sanitary pneumatic conveying solutions offered by Premier Pneumatics, as well as discussion of vacuum sequencing systems, various sanitary P-Series configurations, and loss-in-weight systems, is also included.
www.ktron.com/literature
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13:08 31/07/2008
Experts in chemical imaging
UK. Experts from Malvern Instruments' analytical imaging team are presenting advanced methods and new techniques using near infrared chemical imaging (NIR-CI) at this year's Federation of Chemical and Spectroscopy Societies annual meeting. FACSS 2008, which takes place on 28 Sept - 2 Oct 2008 in Reno, USA, is targeted at analytical chemists and spectroscopists. Malvern's
technical director Dr E Neil Lewis, together with colleagues, will
present Hybrid analytical approaches: Simultaneous physical and
chemical characterisation as a tool for pharmaceutical quality by
design
, describing a new technique for combining morphological and chemical information in a single measurement. Other Malvern specialists will also present papers.
Malvern’s SyNIRgi Near Infrared Chemical Imaging (NIR-CI) systems, coupled with the ISys data analysis software, enables quantitative and spatial identification of chemical species in a sample. NIR-CI is a non-destructive technique that combines traditional near infrared spectroscopy with microscopic and macroscopic imaging. The resulting data is designed to support root cause analysis of manufacturing issues, design and manufacture of products with superior performance and reduction of issues associated with product scale-up.
www.malvern.com
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16:11 30/07/2008
Continuous granulation breakthrough
Collette presented the new CONSIGMA™ continuous high shear granulation and drying system at the recent Interpack show in Düsseldorf, Germany. The launch follows comprehensive testing and sale of machines to major pharmaceutical companies.
The system is capable of particle design, with the ability to mimic any traditional batch granulation process results with a much higher and consistent quality, says Collette. This is achieved through its continuous production set up and 'risk based approach' to GMP. Resulting
granules are said to have better intra-granular porosity and enhanced compressibility characteristics. “Forget about rejects in granulation or tableting: the granules produced will make your tablet presses run more efficiently, at maximum speed with hardly any weight adjustments required”, says the company.
Optional inline measurement of critical quality attributes fed back to the control system allow continuous 'real time' quality assurance to GAMP5. A single unit can run 500g in R & D projects, but can also run a clinical trial, launch size and any production size batches. The aim is to drastically reduce development time and cost and help bring products to market faster. Light
weight, ultra small size (quarter of a normal granulation line) and modular construction allows integration into any R&D department or an existing tablet production room. It is just a matter of wheeling in the unit, connecting it up to power and air supplies and operating it after a short and easy start-up period. Low energy consumption is also a key feature.
www.geapharmasystems.com 18:22 02/06/2008
Pharmaceuticals - manufacturing survival
UK. Ever increasing cost pressures on pharmaceutical manufacturers has encouraged many companies to move production to countries with lower labour costs. It doesn’t have to be this way, says the Institution of Mechanical Engineers, not if established world class methodologies are applied to the plant. The problem will be addressed at a
forthcoming IMechE seminar entitled Pharmaceuticals
manufacturing survival in the 21st century
, taking place in London, UK on 5 June 2008. The IMechE says that many examples of best practice in other industries can be easily applied to this sector and companies that have adopted these practices have significantly improved performance.
The IMechE comments that, while regulatory compliance in UK pharmaceutical manufacturing is generally very high, manufacturing efficiency is often lacking, due to the high costs involved, excessive lead times and inventory, inefficient staffing, poor process control and reliability. This aim of the seminar is therefore to offer advice, solutions and best practice. The aim of the event is to help delegates: benefit from lessons of best practice from other manufacturing industries; build a competitive edge; reduce manufacturing overheads; become more efficient; apply lean manufacturing principles to the organisation; learn about Process Analytical Technology (PAT) and how it can bring benefit; automate operations as far as possible; successfully manage the human factors of manufacturing; understand why outsourcing to India or the Far East may not be as effective as anticipated; network with key industry players; and find collaborators for future projects.
www.imeche.org/events/ 12:25 30/05/2008
US conference for pharma professionals
USA. ISPE, the International Society for Pharmaceutical Engineering, has announced several important sessions this year at its Washington Conference taking place on 2 - 5 June 2008 in Virginia.
"ISPE’s Engineering Regulatory Compliance Conference in Washington, DC is truly a practical engineering forum," says Grace Chin, senior VP of science and technology for SNC-Lavalin and member of ISPE’s Washington conference task team. “The event will provide industry professionals with direct access to regulators who are focused on the real issues we face daily.” One of the
event's highlights is described as a multi-day, multi-track
programme co-sponsored by the US Food and Drug Administration (FDA)
and ISPE entitled, Regulatory Perspectives on Hot Topics,
Regulatory Trends, and Observations
. The interactive sessions provide a forum for exchanging ideas, hearing about new initiatives and give delegates the chance to interface with regulators. ISPE’s Facilities Summit 2008:
Innovation and Ultra Fast Delivery
presents an intensive forum where top thinkers and service practitioners discuss project delivery, regulatory and manufacturing technology/operations. Other important sessions include: containment; barrier isolation technology; critical utilities such as pharmaceutical water and gas systems; commissioning and qualification; GAMP; and designing and validating manufacturing systems.
www.ISPE.org/washingtonconference 20:56 20/05/2008
Presentation shows power of chemical imaging
A new freely downloadable presentation available via Malvern Instruments’ website highlights how SyNIRgi, its powerful near infrared chemical imaging (NIR-CI) system, can provide the data and product understanding required for Quality by Design.
Near infrared imaging of pharmaceuticals and Quality by Design looks at how this measurement technology can help answer the questions of “What? How much? And Where?” It presents a variety of applications in the pharmaceutical industry and a discussion of how to derive statistically meaningful, reproducible and quantitative results. SyNIRgi rapidly identifies, quantifies and locates chemical species within a sample, the information providing valuable insight into product performance, optimising design space definition and specification setting. Short analytical times and no need for sample preparation make the system a ‘go to’ option for QbD related studies.
Researchers can track water gradients in a tablet during hydration, rather than simply monitoring average water content. Distribution of active pharmaceutical ingredients (APIs) can be studied to assess blending or interactions with excipients. Coating quality – thickness, homogeneity – can also be statistically measured. The system is fully automated with the capability to analyse powders, granules, tablets or complete blister packs, in minutes. In excess of 80,000 spectra are collected from across the surface of the sample for each measurement. Statistical analysis techniques, accessed via ISys, a user-friendly software package, extract relevant chemical and morphological information.
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To download the presentation visit: http://www.brainshark.com/malvern/NIR-CI_pharma
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