When tasked with developing medical-grade tubing for one of the world’s leading medical device manufacturers, Milosilicone quickly earned its reputation as the preferred partner. The client sought a reliable solution to ensure the integrity of their tubing components, which were integral to the performance of their Class II medical device. After evaluating various suppliers, Milosilicone’s proven track record in clean manufacturing, stringent processing standards, and commitment to innovation made us the partner of choice. Not only did we deliver high-quality tubing, but we also worked closely with our customer to tackle critical challenges, including contamination risks, material performance, and product traceability.
Extruded Medical-Grade Tubing Requirements
The device in question required multiple types of medical-grade tubing, including both plastic and rubber variants. Given the essential role these components played in the device’s functionality, the quality and reliability of the tubing were paramount. The tubing had to meet the rigorous standards set by medical regulations, ensuring compatibility with the device’s operation. The performance of the tubing was non-negotiable, with particular focus on sterility, material properties, and long-term reliability. In this high-stakes environment, Milosilicone’s expertise became a critical asset in delivering a solution that exceeded the client’s expectations.
At Milosilicone, we fully understand the complexities associated with manufacturing medical device components, especially in the highly regulated world of Class II devices. We see ourselves not only as a supplier but also as an integral part of our customers’ product development teams. Our approach is consultative, offering tailored solutions that go well beyond just providing tubing. Here’s how we helped mitigate risks and enhanced the overall quality of our customer’s product:
Identifying a Superior Material to Overcome Product Issues
A significant challenge encountered during the development process was the issue of “blooming,” a common problem in some plastic materials after sterilization. Initially, the customer had selected PVC tubing, but during testing, the tubing exhibited blooming after Ethylene Oxide (EtO) sterilization. Blooming refers to the migration of chemicals from the material’s surface, which can lead to contamination. Given the critical nature of this medical device, even a minor risk of contamination could undermine the integrity of the product and jeopardize its compliance with stringent medical standards.
Our material specialists at Milosilicone worked in close collaboration with the customer to identify an alternative material that would eliminate the blooming issue. The new material not only addressed the problem of blooming but also demonstrated better compatibility with the EtO sterilization process. This ensured that the tubing would remain sterile and free of contaminants, even after multiple sterilization cycles. By proactively addressing this risk, we enabled our customer to uphold the high standards required for medical-grade components, enhancing both the safety and reliability of their product.
Reducing the Risk of Contamination
Once the material blooming issue was resolved, we turned our focus to another critical concern: contamination. In the medical device industry, the presence of even trace contaminants can have severe consequences for patient safety. Therefore, minimizing the risk of contamination was a top priority. By eliminating blooming, Milosilicone significantly reduced the chances of contaminants being introduced into the medical device through the tubing.
Additionally, our clean manufacturing environment played a crucial role in ensuring that the tubing remained contaminant-free throughout the entire production process. From material handling to extrusion and final packaging, we implemented strict controls to maintain sterility. This comprehensive approach minimized any risk of contamination and ensured that the tubing met the highest quality standards, providing the customer with peace of mind and the assurance of product safety.
Improving Part Traceability and Managing Shelf Life
Beyond material performance and contamination concerns, our customer also faced challenges related to the short shelf life of the extruded tubing. The shelf life of medical device components is a critical factor in ensuring product integrity. To address this challenge, Milosilicone implemented an advanced traceability system that allowed our customer to track each batch of tubing from extrusion through to final packaging.
We marked the date of extrusion on every piece of tubing, providing full traceability and ensuring that each component could be tracked through its entire lifecycle. This system not only met the regulatory requirements but also gave our customer enhanced control over inventory management. Additionally, our flexible production capabilities allowed us to produce tubing in smaller, more manageable batches. This helped keep the parts within their recommended shelf life and reduced the potential for waste, ensuring that the tubing used in production was always freshly extruded and of the highest quality.
Support for Secondary Processes
At Milosilicone, we pride ourselves on offering comprehensive support for secondary processes in addition to manufacturing the core product. In this case, our Application Engineering team worked closely with the customer to optimize secondary processes such as tubing tipping and assembly. A crucial aspect of this was ensuring that the tubing was perfectly compatible with tube fittings to prevent issues like kinking or buckling at the joints.
Through careful adjustments to thermal forming techniques, we were able to eliminate flow restrictions and prevent the tubing from kinking. This not only improved the functionality of the tubing but also ensured that the connection between the tube and fitting was secure, reliable, and leak-free. This attention to detail in secondary processes helped enhance the overall performance and safety of the medical device, ensuring it met all regulatory standards and functional requirements.
Why Choose Milosilicone?
At Milosilicone, we understand that the stakes are high when it comes to medical device manufacturing. We are not just another supplier—we are a trusted partner in delivering high-quality, reliable, and safe solutions. Our expertise in medical-grade tubing manufacturing, coupled with our dedication to clean manufacturing practices and rigorous quality control, makes us the ideal choice for your medical device needs.
Our factory operates under strict quality standards, including ISO certifications, ensuring that we consistently meet the demanding requirements of the medical device industry. We specialize in custom solutions, and our team is committed to working closely with you at every stage of the development process, from material selection to final assembly, to ensure that your product exceeds expectations.
Whether you require tubing for a Class II medical device or need assistance with optimizing secondary processes such as assembly, Milosilicone is your go-to partner. We are here to provide innovative solutions, reduce risks, and improve the quality of your product, ensuring that it meets the highest standards of safety, performance, and reliability.
If you are looking for a trusted partner to help you navigate the complexities of medical device development, Milosilicone is ready to collaborate with you. For more information or to discuss how we can support your specific needs, contact us today. Let us work together to ensure the success of your next project.