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New Electronic Document System Speeds up Microbiological Media Product Shipments
To enhance the speed of delivery of its microbiological media products for environmental monitoring within the pharmaceutical and related industries, Cherwell Laboratories has introduced a new electronic document management system. The new paperless system ensures batch quality records are delivered directly to the email ‘In Box’ of appropriate Quality Assurance personnel. This ensures that all key records are at their fingertips in a timely manner, thereby fast tracking the release of products for environmental monitoring purposes.
Cherwell employs a positive release scheme for all products before despatch and the batch quality records are essential to secure the release of microbiological media shipments from ‘Goods In’ within a pharmaceutical facility. Documentary evidence of sterilisation parameters, source of raw materials and a Certificate of Analysis, covering growth promotion, pH and sterility testing, undertaken within Cherwell’s own laboratories, are all required before use.
Prior to the introduction of the electronic document management system Cherwell would send the quality records only in paper format typically by post, therefore any postal delay could result in delayed release of product at the customers site. “By adopting this new paperless approach we have responded to the requests of our customers to not only fast track customer release of our products, but also ensure greater efficiency and security in the delivery of crucial batch quality documents directly to the relevant quality personnel,” explained Andy Whittard, Managing Director, Cherwell Laboratories. “It also enables us to adopt a greener approach to quality documentation.”
LAB PRODUCTS Circle no. 565 Comprehensive Analysis of Biomaterials
Researchers at the NMI (Natural and Medical Sciences Institute) of the University of Tübingen in Germany are using the Viscotek TDAmax GPC/SEC triple detection system with Omnisec software, both from Malvern Instruments, in their analysis of biomaterials.
Mixtures of different polymers and biopolymers are used in the production of the degradable biomaterials that are the foundation of modern carrier matrices for regenerative medicine. With such applications in human medicine, comprehensive GMP- and GLP- compliant quality control of such polymer blends is becoming increasingly important.
The chromatographic separation of different polymer components using SEC and subsequent triple detection provides an excellent opportunity to obtain a comprehensive picture of the molecular weight and molecular size of different polymers in a single step.
The NMI conducts applied research and development at the interface of biotechnology and materials science. Core competencies are in the pharmaceutical and biotechnology, biomedical engineering, surface and interface technology areas. With strong interdisciplinary working groups, the NMI works with national and international projects in close collaboration with basic research groups, hospitals and companies. The implementation of new findings from science into commercially viable products or processes is the challenge that the NMI has managed successful for 25 years.
Thus, the NMI offers its customers an integrated service from joint research and development projects to internationally usable, pivotal trials for medical devices and medicines. A manufacturing license is planned by mid-2010 for GMP-compliant testing in the production of biomaterials as components of advanced therapy medicinal products.
CHROMATOGRAPHY Circle no. 566
Intelligent Structured Illumination Microscopy Intelligent Structured Illumination Microscopy from Leica Microsystems uses the proven OptiGrid®
LABORATORY PRODUCTS
New Opportunities in the Nanoscopic Analysis of Large-area Samples
Carl Zeiss has launched ATLAS™, a powerful hard- and software package, which, in combination with any scanning electron microscope from Carl Zeiss, enables quick and efficient imaging of large-area specimens with nanometer resolution.
ATLAS is initially being utilised both in the area of neurological research and for traditional routine tasks in histology and pathology. Here, there is an increasing demand for efficient, cost-effective methods of examining a steadily rising number of specimens with constantly increasing sizes using resolutions in the nanometer range. There as well as in numerous future applications, ATLAS will offer users a new degree of productivity.
With suitable specimens, unattended operation can acquire multi-image montages that span extremely large fields of view, permitting capture of regions on the millimeter scale with resolution on the nanometer scale in a handful of hours. The in-built viewer software with integrated zoom function facilitates continous enlargement of the final image from rough overview until nanometer resolution.
The heart of the ATLAS system is an adaptive 16-bit scan generator and dual supersampling signal acquisition system, tightly integrated into the SmartSEM software for microscope control. ATLAS enables acquisition of individual images up to one gigapixel in size (32k x 32k), at up to sixteen bit pixel depth, and calls upon the rich suite of SmartSEM microscope automation features to allow automated acquisition of one or more image montages that may exceed one terapixel in size.
MICROSCOPY Circle no. 567
technique. Working in harmony with Leica’s superior
quality optics, the aperture diaphragm integrated with the fluorescence light path also enhances contrast. The automatic focus function of the OptiGrid® keeps the grid structure in focus, from UV to IR light.
A unique feature of this development is that the same OptiGrid® module can be used both for upright and for inverted Leica research microscopes.
Furthermore, there is no need to change the grid, as one optimised grid covers all magnifications from 10x to 100x, which offers convenience, avoids errors, and saves valuable time. Intelligent Structured Illumination Microscopy from Leica Microsystems gives you a complete system from a single source: The OptiGrid®
module integrated with Leica research microscopes is controlled by intuitive Leica MM AF software and complemented by a wide selection of fluorescence cameras. MICROSCOPY Circle no. 568
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