Mikron medical devices and pharmaceuticals assembly

Successful production of medical devices and pharmaceuticals parenteral products depends on four factors above all: precision, quality, reliability and regulatory compliance. Mikron Automation meets all these needs for the pharma and medtech sectors with a full range of proven and modular platforms that allow customers to tailor ideal assembly solutions. Mikron offers a range of scalable assembly and feeding solutions that extend from proof of principle, through clinical pilot lines, to fully automated assembly and testing.

Mikron has built its reputation on cutting-edge, standardized, self-developed assembly, feeding and testing systems that are ideal for medtech applications thanks to their high degree of flexibility and precision. Modular design guarantees fast and efficient project completion, enabling customers to modify their production quickly in line with market changes at any time, while also facilitating step-by-step investment, ensuring prompt ROI at each stage.

Medical devices and pharmaceuticals applications

Mikron Automation masters the entire operation from the assembly process and the integration of complex processes that guarantee high quality, reliability and superior performance standards.

These capabilities are valued by a leading medical devices and pharmaceuticals players including Alere, Bausch & Lomb, B. Braun, Bespak, Chiesi, Gan & Lee, GlaxoSmithKline, Novo Nordisk, Nypro, Pfizer, Phillips-Medisize, Sanofi Aventis, Schott, The Tech Group, and Ypsomed.

Close to 40 years of process expertise has given Mikron mastery of very complex medtech assembly automation tasks through integrating complex high-speed processes.

Mikron Automation platforms can be applied across the full spectrum of medical devices and pharmaceuticals delivery products. These include: autoinjectors, closer for ISO vials, diagnostic devices, dose counters, inhalers, IV catheters, glass and plastic syringes, lancets, latex and suction catheters, pen injectors, stopcocks, taps and valves.

Pharmaceutical and medical device compliance

To meet the specific needs of the pharma and medtech industries, Mikron Automation ensures that its platforms comply fully with the latest certification standards right from the pilote stage.

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 compatible with 21 CFR Part 11.

Mikron control systems use a vast library of standardized processes to assure the quality, stability and reliability of the final assembly solution, combined with highly capably and adaptable hardware platforms. Together, these ensure that Mikron assembly needs can be configured to almost any assembly need.

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 stations for micro-dosing, application of glues, greases, etc., as well as UV and thermal curing. Welding options include laser, resistance and ultrasonic.

For marking and printing, assemblies can include 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 compatible 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.