Precision Meets Flexibility: Mikron's Scalable Assembly Solutions for Pharmaceutical and Medical Devices

Introduction

In the high-stakes world of pharmaceutical and medical device manufacturing, precision, reliability, and compliance are non-negotiable. Mikron Automation stands at the forefront, offering scalable and customized assembly solutions that cater to the evolving needs of the industry. From low-volume clinical trials to high-volume production, Mikron's platforms ensure that every device meets the highest standards of quality and safety.​

The Importance of Reliable Assembly in Medical Devices

Medical devices such as injection pens, auto-injectors, inhalers, and syringes play a critical role in patient care. Any compromise in their assembly can lead to significant health risks. Mikron's automation equipment is designed to deliver unparalleled reliability and quality, ensuring patient safety and compliance with stringent regulatory standards .​

Mikron's Scalable and Customized Assembly Systems

Mikron collaborates closely with project teams to develop assembly solutions tailored to specific requirements. Whether starting with small-scale lab equipment or scaling up to high-volume production lines, Mikron ensures consistency in processes and parameters. This flexibility allows for seamless transitions as production needs evolve .​

Mikron MAIA: Lab-Scale Assembly Platform

For early-stage development and regulatory approval processes, the Mikron MAIA platform offers an efficient solution. Designed for low-volume production, MAIA is ideal for assembling pen injectors, auto-injectors, and safety syringes. Its features include:​

• Manual component loading suitable for clinical studies.

• 100% servo-controlled operations, eliminating the need for compressed air.

• Compact footprint of just 2m², compatible with ISO 7 cleanroom standards.

• Equipped with Mikron Object Oriented Software (MOOS) for robust data management .​

Mikron MiniCell: Bridging the Gap Between Lab and Production

The Mikron MiniCell serves as a semi-automated assembly machine designed for low-scale production. Utilizing standard building blocks from Mikron’s platform library, MiniCell ensures:​

• Rapid deployment and stable, low-risk production.

• Up to 12 working stations for efficient assembly.

• Compatibility with compressed air systems or onboard compressors.

• Cleanroom ISO 7 compatibility, ensuring sterile production environments .​

Mikron G05: High-Volume Assembly Platform

For large-scale production, the Mikron G05 platform offers a modular and flexible solution. Key features include:​

• Integration of manual, semi-automatic, and fully automatic cells.

• Validated according to GAMP 5 and compliant with 21 CFR Part 11.

• Cleanroom compatibility with ISO 7 standards.

• High-speed operations with up to 100 cycles per minute .

Comprehensive Pre-Production Services

Mikron offers a suite of pre-production services to support product development:​

• Design for Manufacturing (DFM) and Design for Assembly (DFA) consulting.

• Process development studies and Proof of Principle (PoP).

• Assembly of non-commercial products in cleanroom environments.

• Comprehensive validation support in compliance with FDA, GMP, and GAMP 5 guidelines .​

Expertise in Auto-Injector Assembly

With over 50 years of experience, Mikron specializes in auto-injector assembly lines. Their expertise encompasses:​

• Spring handling and insertion.

• Pre-filled syringe handling and placement.

• Controlled force press and vision control.

• Labeling and quality inspection processes .​

Global Presence and Trusted Partnerships

Mikron's global footprint ensures comprehensive support from initial consultations to ongoing customer service. Their trusted clientele includes industry leaders such as Aerogen, Aptar Group, Biocartis, Dr. Reddy’s, Eli Lilly & Company, Biocon, Flex, GSK, H&T Presspart, Nemera, Nypro, Pfizer, Sanofi, and West .​

Conclusion

Mikron Automation's commitment to precision, flexibility, and compliance positions them as a leader in pharmaceutical and medical device assembly solutions. Their scalable platforms and comprehensive services ensure that clients can confidently bring high-quality medical devices to market, meeting the rigorous demands of the industry.​