By Mikron Automation
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Medical and pharma device assembly
Mikron’s wide range of scalable assembly and feeding solutions meet the whole range of medical device needs from proof of principle, through clinical pilot lines, to fully automated assembly and testing.
Mikron’s international reputation for advanced engineering rests on high degree of flexibility and precision that allow it to provide cutting-edge, standardized, self-developed assembly, feeding and testing systems solutions ideally adapted to medtech applications. Modular design guarantees fast and efficient project completion, enabling customers to modify production runs quickly in line with market changes at any time, while also facilitating step-by-step investment, ensuring prompt return on investment (ROI) at each stage.
Device assembly for medical and pharma applications
Over 40 years of process expertise has given Mikron mastery of very complex medtech assembly automation tasks through integrating complex high-speed processes.
Mikron Automation’s assembly solutions allow mastery and end-to-end integration of the entire assembly operation, integrating the various sub-processes, automated checking and testing and operational monitoring required to guarantee high quality, reliability and superior performance standards.
Mikron Automation solutions can be applied across the full spectrum of medical devices and pharmaceuticals delivery products, including glass and plastic syringes, pen injectors and autoinjectors, latex, IV and suction catheters, lancets, molecular diagnostic devices, POCT, closure for ISO vials, inhalers, dose counters, stopcocks, taps and valves.
These capabilities are valued by leading medical devices and pharmaceuticals players including Alere, B. Braun, Bespak, Chiesi, Flex, Gan & Lee, GlaxoSmithKline, Molex, Novo Nordisk, Nypro, Pfizer, Phillips-Medisize, Sanofi Aventis, The Tech Group and Ypsomed.
Pharma and medical device assembly compliance
To meet the specific needs of the pharma and medtech industries, Mikron Automation ensures that its platforms comply in full with the latest certification standards from the pilot stage all the way through to final production.
The entire Mikron product family takes account of the special conditions governing clean room ISO 7 applications. All the basic hardware and software are validated to GAMP-5 and compliant with 21 CFR Part 11.
Mikron control systems combine highly capable and adaptable hardware platforms with a vast library of standardized processes to assure the quality, stability and reliability of the final assembly solution. Together, these ensure that Mikron assembly solutions can be configured to almost any assembly need.
Standardized processes include automated feeding from bowls, flexible or tray feeds, sensitive handling of glass, needles and other fragile items, a wide range of test capabilities including functionality, flow and leak, torque settings, needle tip, angle and length vision checks, occlusion, pull, quality, vision and X-Ray tests.
Mikron also provides modular stations that can be ‘slotted in’ to deliver micro-dosing (spotting), application of glues, greases, etc., as well as UV and thermal curing. Welding options include laser, resistance and ultrasonic.
Marking and printing modules can deliver hot foil marking, inkjet printing, labels, laser marking and pad printing.
Data management capabilities include data capture, line management, trace and track info and compilation of statistics.
Quality and Certification
Mikron Automation ensures all platforms fully comply with the latest pharmaceutical medical device certification standards right from the concept stage. All basic hardware and software platforms are validated to GAMP-5 and compliant with 21 CFR part 11, with specific emphasis on ergonomics and tool cleaning to ensure conformity with GMP standards.
The entire Mikron product family takes account of the special conditions governing clean room ISO 7 application.
To date, Mikron Automation has installed more than 3500 assembly and testing systems for customers worldwide. The division employs over 650 people at Boudry and its other sites in Berlin (Germany), Denver (USA), Singapore and Shanghai (China). All sites meet ISO 9001 standards, with Boudry certified to ISO 14001.