Originally Published EMDM May/June 2001
Showstoppers
A selection of innovative products and services exhibited at Interphex (Philadelphia, PA, USA) and National Manufacturing Week (Chicago, IL, USA)
Design software
Software Streamlines Part Inspection and 3-D Modelling
A piece of software called Geomagic Qualify allows automatic graphical comparisons between a CAD master model and the built part or object. The program was introduced by Raindrop Geomagic (Research Triangle Park, NC, USA) at the National Manufacturing Week show in Chicago.
Shop-floor inspectors, technicians, and design engineers can use Geomagic Qualify to evaluate and report deviations between designed and built parts. Inspections can be performed with one click of the mouse and shared with colleagues via automatically generated, Internet-ready HTML reports. Raindrop Geomagic reports that the program provides accurate comparisons that allow users to comply with even the strictest deviation standards.
Important features of the software include automatic alignment, IGES and STEP import, tolerance and deviation computation, colour mapping of results, and annotations. It aligns and scans data and CAD models automatically for precise comparisons. Users can specify the level of tolerance for comparisons and report deviation results in minute detail. Deviation levels are displayed graphically using customized colours. Comments or deviation data can be added to a Qualify model for use in reports and presentations.
Geomagic Studio 3.1, another program introduced at the show, takes both geometric and photometric data and transforms them into realistic 3-D models for manufacturing, biometric, and e-commerce applications. Fully automated and easy to learn, Geomagic Studio is designed for use by both modelling experts and beginners.
Filling technology
Barrier Isolation Becoming Commonplace, Says Manufacturer
Hoping to make pharmaceutical packagers more comfortable with barrier isolation technology, Bosch Packaging Technology (Minneapolis, MN, USA) dedicated a sizable portion of its booth at Interphex 2001 to demonstrating the wide industry use of barrier isolators. The basic principle of barrier isolation is that a small, clean environment is created and maintained around the filling area of a production line, isolating that line from surrounding contaminants, including operators. According to the firm, in less than a decade barrier isolation technology has moved from a concept to full-scale production equipment.
"Barrier isolation is an established technology," explains Bosch's marketing manager Bill Arden. He points to US FDA's recent approval of the erectile dysfunction drug Caverject, which is handled in a barrier isolation system used by the drug's manufacturer Pharmacia.
At Interphex, Bosch displayed its MAFS (Mini Aseptic Filling System), which Arden says achieves the kind of aseptic conditions previously attainable only through terminal sterilization and cleanrooms. Such conditions are suited for parenteral injectable drugs that cannot be terminally sterilized, such as biopharmaceuticals. The system encloses the entire filling area within a barrier isolator, providing a level of control that prevents microbial contamination prior to and during filling, checkweighing, and stoppering. Vial washing, depyrogenation, and capping are integrated with the barrier isolator to create a complete aseptic filling system.
Packaging materials
Printed Tear Tape Catches the Eye and Protects the Consumer
Thin strips of tear tape for use on single or bundled wrapped products ease package opening while offering tamper evidence and enhanced brand presentation. At Interphex 2001 in Philadelphia, PA, USA, P. P. Payne Inc. (Colonial Heights, VA, USA, and Nottingham, UK) introduced its latest generation of Supastrip XL tear tape technology, Supastrip Impact, designed to carry printed messages and designs. The tape can also bear standard or custom holograms, explains Tom Bass, sales executive for P. P. Payne.
According to Bass, the tape allows manufacturers to indicate that their wrapped products have not been tampered with or been removed from bundled packs. "The tape is good for use on retail and distribution packs," he adds.
To make strip application easy, P. P. Payne supplies equipment for placing the tear tape onto the overwrap film before wrapping single or multiple products. The tape is available in reel lengths up to 100,000 m, minimizing the downtime required for reel changes on the wrapping line.
The Supastrip Impact tape is printed using gravure cylinders, which help ensure accurate printing registration of text and designs even at narrow widths. The preprinted tape can eliminate the need for preprinted overwrap film.
More than 40 years ago P. P. Payne developed pressure-sensitive, self-adhesive tape as a replacement for conventional tear tape systems that required wax and heating equipment to bond the tape to the overwrap.
Testing equipment
Inspection System Catches Errors in Blister Filling
Using near-infrared light, an inspection system ensures that the right tablets have been placed into the right blister packages on a form-fill-seal line, without touching a single tablet. Developed specifically for integration into blister-forming lines from Klöckner Medipak (Clearwater, FL, USA), the QualitySpec TI system from Analytical Spectral Devices Inc. (ASD; Boulder, CO, USA) verifies the chemical composition of solid-dosage products in each individual pocket of a blister package.
Traditional pharmaceutical blister packaging equipment relies on inspection systems that visually identify tablets by shape, size, and colour, explains John Enterline, director of sales and marketing at ASD. "Until this time, however, there were few systems that could distinguish whether an errant tablet of the same size, shape, and colour was put into a package," he adds. "With the integration of our QualitySpec TI NIR analyzer this is now possible. We are able to read the chemical fingerprint of each drug."
With fibre-optic probes positioned above each blister cavity, the analyzer interprets the tablets using the firm's field-proven spectrometer, which measures reflectance, transmittance, and transreflectance and features a spectral range of 350 to 2500 nm. It maintains a wavelength accuracy of ±0.8 nm and a wavelength repeatability of ±0.02 nm. Photometric range is 5 AU and noise is 60 µAu.
Featuring a scan time of 0.1 seconds, the system is designed for high-volume production environments. It has an evaluation speed of 90 cycles per minute per head that can easily accommodate up to 200 tablets per cycle, giving it the ability to scan 18,000 tablets per minute.
Injection moulding
Magnesium Alloys Benefit Special Applications
Manufacturers are demanding lighter, stronger, thinner, less expensive, and more durable components. The dominant processing technologies are plastic injection moulding and metal die casting, both of which have material and production limitations for some applications.
An alternative technology was shown at the National Manufacturing Week show in Chicago. Thixomolding, offered by Thixomat (Ann Arbor, MI, USA), is based on the high-speed injection moulding of semisolid thixotropic alloys and yields net-shape magnesium components. The process combines the light weight, high strength, high ductility, and EMI/RFI shielding characteristics of magnesium with a safe, environmentally friendly process that allows the manufacture of thin-wall components to tight tolerances.
The Thixomolding process is based on the principle that magnesium, aluminium, and zinc alloys become semisolid as temperatures approach the melting point. Mechanical shearing of the semisolid metal generates a thixotropic structure that allows these materials to be moulded in a manner similar to plastics.
The samples shown at the show—enclosures and instrument panels—were remarkably thin and light. Parts with wall thicknesses as thin as a half millimetre are possible. However, Herbert Pritzker, director of marketing at Thixomat, cautions that the process is not well suited to all medical device applications.
"The technology is best suited to high-volume production," says Pritzker. "Also, this is not a substitute process. You wouldn't want to replace just any plastic part that you are currently moulding with Thixomolding. Rather, you use the technology when it's possible to take advantage of its benefits," he says, citing the example of cell phone manufacturers that have used the technology to make cell phone covers. "With these covers, they are able to eliminate the EMI/RFI shielding that normally has to go inside the phone," he says.
Thixomolding also has environmentally friendly features that eliminate the harmful gasses and solid waste associated with die casting. Additional benefits include mechanical properties equal or superior to die casting, improved corrosion resistance, and high repeatability of complex shapes. Thixomat holds the exclusive rights to the patented process and licenses the technology out to manufacturers. The firm also provides education, research, and support to its customers.
Manufacturing software
Software System Enables Remote Equipment Monitoring
Chicago's National Manufacturing Week show saw the introduction of what eMation (Mansfield, MA, USA) calls Device Relationship Management (DRM) software. The software allows manufacturers and service providers to maintain continuous Internet connections with their equipment at customers' facilities throughout the products' life cycle.
The eMation DRM system comprises a comprehensive family of infrastructure and application software components that interoperate to form an Internet-based distribution system.
"In today's competitive marketplace, companies need to do more than react. They must anticipate the needs of their customers," says Dale Calder, president and CEO of eMation.
The eMation DRM system's scalable, fault-tolerance application server, hosted at the customer's site, communicates, stores, and manages information exchange with remote devices. A modular embedded application server, resident within each device or an attached gateway, provides local decision making, data aggregation, and XML-based secure communications.
According to Paul Henderson, the firm's vice president of marketing, the software has its origins in specific requests from medical OEMs. "Their customers were complaining about too much downtime with their equipment," he says. "But often when they'd send their staff out to fix the machines, they'd find that the problem had been caused by lack of maintenance."
The eMation DRM software system allows manufacturers and service providers to monitor the minute-to-minute status of their devices so that they can predict when a device will malfunction and take action to prevent a complete failure. If there is a breakdown, they can diagnose it and perhaps determine which part needs replacing, allowing a service technician to bring the needed part instead of having to make two trips.
"This technology can even allow the manufacturer to calibrate its machines for the customer," says David Helinek, medical and transportation marketing manager at eMation. "If necessary, equipment could easily be recalibrated every time someone used it."
Rapid prototyping
Laser-Sintered-Metal Prototyping Yields Durable Metal Parts
Laser sintering of metal is one of the fastest ways to create fully dense metal parts, prototypes, and tooling inserts for plastic injection moulding. At the National Manufacturing Week show in Chicago, Rapid Prototype Company, Inc. (Auburn Hills, MI, USA), displayed LaserForm ST-100, a powdered metal material made with a stainless-steel alloy. The firm uses the material to produce complex, durable metal parts directly from CAD data. The metal material provides a good surface finish and a strong model. Parts can be polished, textured, plated, and machined, and typical turnaround time is four to seven days.
Laser-sintered metals offer two advantages. First, cavity and core tooling inserts can be created quickly using production materials. "Most other short-run or bridge-tooling options can't run production materials, and the few that can don't get high part volume because the tooling quickly wears," says Rob McCarthy, the company's marketing manager.
The other advantage of this process is that it can be used to create metal parts directly. "Previously, parts could be made in nylon materials, or in photo polymers, and used to evaluate form. But if the part is metal in production, a plastic one just doesn't have the same feel," says McCarthy. "Our experience working with designers is that they want the feel of the real thing," he continues. "Previously this meant machining parts, investment casting, or sand casting. These are all good processes, but they take more time and are limited by process constraints. With the sintering process, we can provide multiple iterations in less time."
Reported by Daphne Allen and Karim Marouf
Copyright ©2001 European Medical Device Manufacturer
