By Mikron Automation
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Pharma & medical device assembly
Mikron meets the whole range of pharma and medical device needs from proof of principle, through clinical pilot lines, to fully automated assembly with a wide range of scalable assembly and feeding solutions.
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.
Mikron’s modular design principles assist versatility and adaptability while its in-depth assembly expertise helps assure fast and efficient project completion. These advantages also enable 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 pharma and medical applications
Mikron’s mastery of very complex medtech assembly automation tasks is based on four decades of accumulated process expertise combined with specialism in integration of highly complex high-speed processes.
Mikron Automation’s pharma and medical device 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 are applicable across the full spectrum of medical devices and pharmaceuticals delivery products, including glass and plastic syringes, pen injectors and autoinjectors, DP and MD inhalers, diagnostic devices, patch devices, wearable pumps, wearable monitoring devices, connected devices, IV and suction catheters, closure for ISO vials, dose counters, stopcocks and valves.
These capabilities are valued by a leading medical devices and pharmaceuticals players including Abbott Alere, Bausch & Lomb, B. Braun, Bespak, Biocartis, Biocon, Boston Scientific, Chiesi, Flex, Gan & Lee, Gerresheimer, GlaxoSmithKline, Jabil, Nemera, Novo Nordisk, Nypro, Pfizer, Phillips-Medisize, Sanofi Aventis, Schott, Sun Pharma, West Pharmaceutical and Ypsomed.
Pharma and medical device assembly compliance
Mikron Automation ensures that its platforms comply in full with the latest certification standards to meet the specific regulatory needs of the pharma and medtech industries, from pilot stage all the way through to final production.
Mikron solutions combine highly standard and adaptable hardware and software platforms such as G05 and EcoLine with a range of standardized systems that include the Polyfeed, an automated component feeding complex parts and flexible vision guided feeders. The Mikron Tray Handler provides sensitive handling of fragile parts.
A core capability of Mikron is the development and integration of complex processes. Over 350 processes are available to assure the quality, stability and reliability of the final assembly solution and speed the configuration of Mikron assembly system to any specific assembly need. Key processes available from library include:
- Micro-dosing, spotting
- Micro dispensing of glues, greases, etc.
- UV and thermal curing
- Laser cutting and welding
- Marking and printing stations that can deliver hot foil marking, inkjet printing, labels, laser marking and pad printing
Over many years, Mikron has developed its control systems to deliver key capabilities such as data capture, line management, Track & Trace information and compilation of statistics.
Quality and Certification
All Mikron hardware and software assembly platforms are engineered to be compatible with the latest pharmaceutical medical device certification regulations, being validated to GAMP-5 standards and compatible with 21 CFR part 11 guidelines, with specific emphasis on ergonomics and tool cleaning to ensure conformity with GMP standards.
The entire Mikron product family also takes account of the special conditions governing clean room assembly to ISO 7 standards.
To date, Mikron Automation has installed more than 3500 assembly and testing systems for customers worldwide. The division employs around 700 people at Boudry (HQ, Switzerland) and its other sites in Berlin (Germany), Kaunas (Lithuania), Denver (USA), Singapore and Shanghai (China). All sites meet ISO 9001 standards, with Boudry certified to ISO 14001.