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Pharmaceutical Manufacturing and Packing Sourcer

Satisfaction Guaranteed

Mikron Automation continuously innovates to supply sophisticated automated assembly and test solutions for disposable devices such as inhalers, pen injectors, auto-injectors, safety syringes, e-devices, test and diagnostic kits, lancets and pumps.

Core competencies include the use of highly standardised manual, semiautomatic and automatic modules from the pilot line up to the fully automatic line and expertise in complex process integration.

Products and services for the pharma and medical industries are grouped under the following five main sections:

1. AUTOMATION PLATFORMS

High precision, cam-driven, modular and expandable assembly systems, such as Mikron G05 and Mikron EcoLine, allow multiple cells to be linked side by side or back to back to optimise the layout and manual stations to be combined with automated processes. This allows progressive investment and easy scale-up from pilot scale to fully automated assembly.

The primary motions of the assembly module are cam driven, thus guaranteeing perfect synchronisation between the working units and the pallet indexing mechanism. Each assembly step is followed by a systematic check to ensure continuous and consistent quality.

The solutions operate at speeds of up to 100 cycles per minute with outputs up to 500 parts per minute.

2. FEEDING PLATFORMS

Based on wide-ranging experience in the assembly field, Mikron Automation offers specific feeding platforms ranging from tray handlers to flexible feeding systems. Fully integrated with Mikron automation platforms, these feeding solutions add value with high productivity, flexibility, reliability and user-friendly operation.

Tray handling systems, such as the Mikron Tray Handler and EcoPal, are designed for components that are sensitive to damage or contamination, while the Mikron Polyfeed provides unrivalled flexibility for evolving or complex geometry components and variants. The entire family of Mikron products takes into account the special conditions for cleanroom ISO 7 (class 10,000) applications.

3. VISION SOLUTIONS

Mikron Automation specialises in integrating sophisticated machine vision processes into automated assembly processes. The company’s own developments – Totem multiple camera and Shaman PC-based data management – comply with the most stringent certification standards, such as 21 CFR Part 11.

4. PHARMA AND MEDICAL QUALIFICATION SUPPORT


The company offers a full range of consulting services and is committed to supporting full compliance with rigorous standards. They can provide documentation harmonised for North American, European and Asian markets, approved and ready for use during FDA validation.

Basic software has been pre-validated according to Good Automated Manufacturing Practice 5 and is 21 CFR Part 11 compliant, with more than 200 tests already completed, leaving only quality-critical system elements to be validated. Specific emphasis has been put on ergonomics and cleaning of tooling to meet the Good Manufacturing Practice norms. A dedicated and skilled team with medical project expertise supports the project team from design to delivery.

5. CUSTOMER SERVICE

Following installation, customised training and production assistance introduces clients to the feel and function of the new system. This accelerates productivity by reducing the personnel learning curve. Support continues with remote maintenance tools, a service hotline, and the expertise of technicians who arrive onsite to personally provide help throughout the entire service life of each client’s assembly solution.

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