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Mikron Automation becomes leader in complex assembly of on-body injection devices
Boudry, Switzerland: – Swiss-based medical assembly process specialist Mikron has detailed its recent advances in the assembly of tiny and complex on-body injection devices in a newly published magazine article.
The Mikron-authored feature published in the online journal ONdrugDelivery highlights the assembly challenges that the company needed to overcome in handling and manipulating the highly miniaturized parts needed to make up injection devices that can be directly positioned on the skin in the the treatment of diabetes and other chronic diseases.
Pushing the boundaries
Overcoming the on-body injector challenge required Mikron Automation to draw on its impressive track record as a leading partner for scalable and customized assembly with more than 3,900 assembly systems installed worldwide and its accumulated experience in the pharmaceutical industry, particularly in the complex assembly of delivery devices.
Mikron Automation is also well-versed in the diabetes market, having produced numerous assembly systems for pen injectors and other connected devices, such as auto-injectors. Body injectors represent the latest emerging technology to experience booming demand since 2013.
Embarking on the assembly of a new type of highly innovative device is always a challenge, especially in areas where designs are still evolving.
“It required us to go even further in our capabilities to implement miniature part assembly processes in order to be able to achieve these previously unattainable high-precision systems,” commented Jean-François Bauer, Head of Marketing & Business Development at Mikron Automation.
On-body drug delivery devices are pushing the boundaries of miniaturization and are also highly complex, requiring many parts, some no larger than a few tenths of a millimeter. As an example of the assembly challenge, internal silicone seals have an external diameter of less than 1 mm and are both soft and sticky, making all gripping, placement and control operations during assembly particularly problematic. Similarly, drug delivery needles are also extremely thin but have to be precisely bent while not blocking passage of fluid.
Challenges such as these required Mikron Automation to develop a system that could assemble various miniature components almost invisible to the naked eye.
“We had to had to perform micro-assembly and micro-adjustment operations that we had never done before,” noted Flavio Pointet, Key Accounts Manager at Mikron Corporation Denver, Colorado, USA.. The solution was to use high resolution cameras and large screens that allowed operators to zoom in on certain areas of intervention during the assembly process and make extremely fine adjustments and specific alignments.
A further automation challenge was working in an emerging market with many products still under development.
“For the past five years, clients have been asking us for help well before the clinical testing phase. They have a clear idea, prototypes of parts made in 3D printing, but they are still very far from the final product stage,” Flavio Pointet explained.
To meet such needs, Mikron has expanded its Pre-Production Services to include provision of Proof of Principles (PoP) to demonstrate ability to perform certain assembly processes and key operations so that they can be integrated into the overall assembly system. Similarly, Mikron will engage in its partners during their product development phase to suggest design improvements. For some projects, Mikron Denver also provides use of its ISO13485 certification and qualified Class 7 clean room in which device-level tests can be carried out. In effect, the Mikron’s assembly system is developed in synchronous lock step with the customer’s device.
Early stage Mikron involvement in the customer project means that a relationship based upon trust must be established between the two parties.
“This implies that there is an open communication and a real collaboration between the two partners. Very often, clients are developing new products that have a lot of intellectual property. Confidentiality and trust are essential to the success of the program,” says Jean-François Bauer.
The article concludes that Mikron Automation has proven to be a partner of choice, enabling the best risk mitigation for a customer, thanks to the security offered by its process expertise, its corporate culture based on customer success, and its global scale, which enables it to support the challenges of such projects financially.
About Mikron Automation
Mikron Automation is the leading partner for scalable and customized assembly systems – from the first idea to the highest performance solutions. Distinguished by a commitment to innovation, flexibility, unparalleled customer service, and an evolving platform portfolio, Mikron delivers state-of-the-industry solutions to the most complex assembly and testing demands.
Mikron Automation currently employs around 750 people and is headquartered in Boudry (Switzerland), a region that is regarded as the heart of the Swiss watchmaking industry. It also has sites in Denver (USA), Singapore, Shanghai (China) and Kaunas (Lithuania). The Mikron Group, a publicly-traded company with more than 100 years’ experience in precision machinery.
To date, Mikron Automation has delivered thousands of assembly solutions for a variety of drug delivery and diagnostics devices including inhalers, pens/auto-injectors, catheters, e-devices, wearables, and point-of-care tools. It also offers a constellation of high-added-value services that cover their products’ full lifecycle, wherever its customers are in the world. Mikron’s Quality Teams offer full validation support in accordance with FDA, GMP and GAMP 5 guidelines.
Further information at: https://www.mikron.com/automation-solutions/
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