ASSEMBLY
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An integral needle safety syringe assembly machine, developed by Kahle Automation (Caravaggio, BG, Italy), can assemble and inspect needles at speeds in excess of 1000 parts/min.
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About a decade ago, automation played a limited role in the manufacture of medical devices. For most companies, manual assembly of medical devices was the norm and automation was used mainly for material handling and packaging. Although a significant amount of medical device assembly is still performed by hand, most medical device firms rely on at least some form of automation equipment to provide production efficiency, quality control, and data collection capability that would otherwise be impossible to obtain. "There is a growing percentage of medical device components that cannot be produced manually," says Alexander Sedlak, manager of technical marketing at ATS Automation Tooling Systems (Munich). "With each successive product generation, medical devices are becoming smaller and more complex, driving the demand for automation equipment that does not only meet high precision requirements but is also flexible."
A race to miniaturize
Among prevalent developments in the medical device industry, miniaturization is emerging as one of the most ubiquitous. "Certainly, miniaturization is a trend that we are seeing in medical electronics, whether it be a pacemaker or hearing aid," says Terrence Woldorf, director of marketing at EFD, a subsidiary of Nordson (East Providence, RI, USA), which manufactures fluid dispensing systems used in medical device assembly. "As a result, more and more companies are using components that are increasingly hard to manufacture as they decrease in size," he adds. And with demand for medical devices continuing to grow, slowing down production of medical equipment is not an option. "We realize that medical device companies are facing increasing demand for their products. To maximize production efficiency, we carefully consider how we engineer a system, integrating all of the different stages of manufacturing and verification," Woldorf explains.
To deal with miniaturization, medical device firms are adapting strategies from the electronics industry, says Nancy Gleason, director of the life science division of Nordson. "We have found that some technologies used in electronics manufacturing are applicable to the medical device industry," she explains. "In particular, jetting technology used for electronics manufacture lends itself very well to many medical device applications." The advantages of fluid jetting for the medical device market include accuracy, consistency, noncontact clean application, and the ability to dispense precise amounts of fluids. The technique can be used for dispensing reagents and phase-change materials such as paraffin waxes on microfluidic chips.
Piezoelectric dispensing, another technology growing in popularity, can offer rapid and precise dispensing of microscopic quantities of fluids. Formerly used for ink-jet printing, "it took a lot of work to make piezoelectric dispensing able to handle a lot of different fluids for the assembly market," Woldorf notes. "But now, this technology can be used for an almost infinite variety of applications and this has a lot of potential for applications in life sciences," he adds.
Meeting regulatory requirements
Medical device firms also must conform to increasingly stringent regulatory demands. "Aside from the need to manufacture at high speeds, medical device firms want automation equipment with improved quality control capability and complete validation documentation," says Julie Logothetis, president of Kahle Automation (Caravaggio, BG, Italy). "Kahle meets increased regulatory and quality control requirements through risk analysis of the manufacturing and inspection processes during the machine design and building process," Logothetis explains. "To meet our customers' needs, we supply a complete validation package of documentation on the completion of the machine." Focusing solely on assembly machines for medical devices, the company offers machine validation services that meet the standards outlined in US FDA's Title 21 CFR Part 820. As an added measure of safety, the company inspects and validates every control process of its machines on the factory floor and at its customer's site after installation.
With a significant number of its automation machines destined for use in the US market, sortimat Technology (Winnenden, Germany) also has achieved compliance with US FDA regulations in its machinery. For instance, the company's Spaceline flexible assembly system, which can assemble medical devices without the need for infeed conveyor belts, is also compliant with 21 CFR Part 11 and can be qualified according to GAMP 4. To meet the regulatory requirements, the firm defined and programmed the system's interface to generate an audit trail of operator activity.
