EQUIPMENT NEWS
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Solid-seal-bar vacuum chamber machines provide packaging validation
Vacuum chamber systems with solid seal bars produce a constant, verifiable temperature across the entire sealing surface during the full sealing cycle. A mainstay in the rollstock machines of Multivac (Wolfertschwenden, Germany), the bars now have been adapted for use in Multivac’s chamber machines; several safety features have also been added. The technology provides med-tech OEMs with a new tool for package validation.
Package validation programmes also can be designed using the company’s traditional pulse sealing chamber machines. However, the suitability of pulse sealing for certain types of medical products has been called into question. Solid-seal-bar machines provide an alternative to this technology, notes the firm, and allow manufacturers to sidestep the controversy entirely.
Solid-seal-bar technology has been incorporated into the company’s medical-grade C400 and C500 chamber systems.
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Mass flowmeters suited for lab and production environments
Mass flowmeters are designed to perform quality control of gas flows in laboratory or manufacturing settings. Manufactured by TSI Instruments Ltd. (High Wycombe, Bucks, UK), the meters provide accurate results and feature multiple data output options. The serial and analogue outputs make the devices suitable for production-floor quality control and built-in systems.
The mass flowmeter sensors are specified as within 2% of reading. A 4-millisecond response rate ensures accuracy in flow fluctuations and enables rapid throughput in manufacturing environments. The response time is also advantageous for closed-loop control systems and integrated volume measurements.
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Ionization monitor reads peak-to-peak pulse swings
Described as the only monitor with onboard technology scaled to accurately read wide peak-to-peak pulse swings associated with pulsed or bipolar ionization, the Equilibrion CTC039 also provides automatic and continuous balance and decay-time indications. Developed by Credence Technologies (Soquel, CA, USA), the device can interface with facility monitoring systems and provide a steady stream of data on all ionization parameters.
Many tools come equipped with integrated ionization, but determining if the ionizer is operating within specifications or is even turned on generally requires that the user suspend tool operation. The CTC039 enables users to monitor ionization while the tool is functioning. A remote display is available as an option. Connected to the Equilibrion device, the display provides a status report on ionizer performance.
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Spectroscopes may reduce development times
Integrated spectroscopy modules for OEM use may help to reduce development times, according to a manufacturer. The modules, recently introduced by Horiba Jobin Yvon Ltd. (Stanmore, Middx, UK), are suitable for process monitoring, colourimetry, and analytical chemistry applications.
Available exclusively to OEM customers, the modules can help to quickly define performance parameters, after which a fully customized spectroscopy device can be designed. The modules are designed around a family of aberration-corrected holographic concave gratings. They offer optimal optical performance while minimizing stray light, and feature the largest aperture in their class.
The modules can be equipped with either linear CCD detectors for high sensitivity or a photodiode array ensuring a wide dynamic range and high signal-to-noise ratio when coupled with a 16-bit A/D convertor.
X-ray inspection systems help companies meet GMPs
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Real-time x-ray inspection systems that support process and quality control procedures can help companies to meet US FDA GMP guidelines. The MedaScope from Glenbrook Technologies Inc. (Randolph, NJ, USA), with up to 20× variable image magnification, can visualize flaws in soft materials such as moulded plastics, rubber, and silicones, as well as in ceramic and metal devices. The combination of sensitivity and high resolution enables the rapid detection of flaws in hard-to-image materials during the production process. Injection moulded parts with internal components that require nondestructive inspection are good candidates for this type of inspection system.
The MedaScope system is available as a console with an x/y positioner; a wheeled base and conveyor system for automatic inspection on the production line is available as an option. A portable desktop version weighing only 45 lb can be set up rapidly for laboratory or production tasks.
The company also offers a Jewel Box system with a five-axis positioner for laboratory applications. The device uses the same imaging technology and is equipped with a microfocus x-ray tube and a zoom that has up to 500× continuous magnification. It is typically used to inspect stents, guidewires, vascular closures, and drug-delivery devices.
X-ray systems supplier also offers inspection services
An x-ray inspection system is designed to image complex components for quality assessment and process improvement purposes. The Feinfocus Cougar-SMT with CT unit from Comet GmbH (Garbsen, Germany) enables real-time 16-bit image processing and accelerated CT reconstruction and visualization. The system provides feature recognition down to 1 µm and up to 10,000× total magnification.
The international manufacturer and supplier of high-resolution x-ray inspection systems also offers a full range of options with its global x-ray inspection services. The company’s service and application engineers can provide assistance ranging from full on-site service for high-volume inspection to real-time Web interfacing from one of the service provider’s worldwide test and inspection centres.
Service capabilities include 2-D high-resolution x-ray inspection involving oblique viewing at almost any desired angle, high-volume 2-D inspection at rates above 4000 samples a day, 3-D µCT x-ray inspection for full failure detection based on 3-D models, and 3-D µCT Web interfacing, providing real-time 3-D cross sections via a secure Internet connection. Feinfocus inspection systems and the company’s patented HDX-Ray imaging technology are used for all services.
Software streamlines data flow related to product defects and returns
Web-based software has been developed that aggregates data from various return material authorization (RMA) databases, thus allowing users to easily determine the root causes of product defects and to mine other statistics about product performance trends. The product is designed to enable manufacturers to correlate information on the types and quantities of parts or products that are failing following shipment. Currently, many companies have few options other than to upload the data into spreadsheets and try to analyze them manually.
RMA data often are provided in a variety of formats. SigmaSure RMA Insight from SigmaQuest (Santa Clara, CA, USA) enables quality assurance, engineering, operations, customer service, and other departments to easily access information from disparate database systems and to drill down to the root cause of problems. The software also allows tracking specific details such as serial numbers, the number of defective products shipped, and so forth.
SigmaSure RMA Insight can be used as a standalone product or as part of the company’s SigmaSure Enterprise Suite that correlates warranty data with supplier, design, and manufacturing data. The software can be accessed via any Web browser.
QM software helps firms achieve compliance with multiple norms
Quality management software that is designed to help companies comply with US FDA and ISO requirements reportedly also can help them to achieve compliance with the US Sarbanes-Oxley Act (SOX). Documentation, control, and process requirements for producing financial statements under SOX are similar in some respects to those required for ISO and GxP compliance, according to MasterControl Inc. (Salt Lake City, UT, USA), which has developed the quality management suite.
Companies operating within regulated environments share a number of needs, notes the firm. For example, they must manage voluminous data, establish a central repository that is secure yet accessible to authorized users, efficiently route documents, monitor various processes, and maintain compliance on an ongoing basis. This is true of SOX, which, it should be noted, also poses some additional challenges. The MasterControl suite offers a companywide quality management system that can help to achieve these and other requirements.
Document management automation, a routing function that generates a comprehensive audit trail, and the automation and management of form-based processes are among the program’s features. The system has been designed for easy navigation; an Internet-based architecture connects employees, vendors, customers, and auditors, regardless of where they are located.
