When faced with the challenge of developing medical-grade tubing for one of the world’s largest medical device manufacturers, Colosilicone quickly distinguished itself as the preferred partner. The customer was seeking a solution to ensure the integrity of their tubing components, crucial to the function of their class II medical device. After considering various potential suppliers, Colosilicone’s capabilities in clean manufacturing and rigorous processing stood out. We not only provided high-quality tubing but also worked closely with the customer to address critical concerns such as contamination risks, material performance, and product traceability.
Extruded Medical-Grade Tubing Requirements
The medical device in question required several types of tubing, including both medical-grade plastic and rubber options. Given the critical role these components played in the device’s performance, the quality and reliability of the tubing were paramount. The tubing needed to meet stringent regulatory requirements while ensuring compatibility with the device’s functionality. In this context, the performance of the tubing was non-negotiable, particularly in terms of sterility, material properties, and long-term reliability.
At Colosilicone, we understand the complexities involved in medical device manufacturing, particularly when it comes to meeting the high standards required for class II devices. We were not just another supplier—we became a key part of our customer’s problem-solving process, offering solutions that went well beyond the basic tubing supply. Here’s how we helped reduce the customer’s risk and improve the overall quality of their product:
Identifying A Better Material To Eliminate Product Issues
One of the most significant challenges faced during the development process was the issue of blooming. During testing, the initial PVC tubing that had been specified exhibited blooming after Ethylene Oxide (EtO) sterilization. Blooming refers to the migration of chemicals from the material’s surface, which can lead to contamination risks. This issue could severely compromise the integrity of the device, affecting both its performance and its compliance with stringent medical standards.
Our material experts at Colosilicone worked closely with the customer to identify an alternative material that would eliminate the blooming issue altogether. The new material was not only more stable but also more compatible with the Ethylene Oxide sterilization process, ensuring that the tubing would remain free of contaminants after sterilization. By providing this tailored solution, we helped our customer mitigate a significant risk in the production process and maintain the high standards required for medical-grade components.
Reducing The Potential For Contamination
With the material blooming issue addressed, the next critical concern was the potential for contamination. Contamination is a major risk factor in the medical device industry, where the slightest trace of foreign material can have severe consequences. By eliminating blooming, Colosilicone significantly reduced the possibility of contamination being carried within the tubes, which could lead to complications in patient safety and device functionality.
Furthermore, the clean manufacturing environment at Colosilicone played a crucial role in ensuring that the risk of contamination was minimized at every stage of the tubing production process. From material handling to extrusion and final packaging, our rigorous processes ensured that the tubing remained sterile and free from contaminants, providing the highest level of assurance to our customer.
Improving Part Traceability And Addressing Short Shelf Life
In addition to addressing material and contamination issues, our customer faced challenges in managing the shelf life of the extruded tubing. Ensuring that the tubing was used within its recommended shelf life was critical to maintaining product integrity. Colosilicone implemented a traceability system that helped the customer manage this challenge effectively.
To address the short shelf life, we ensured that each batch of tubing was extruded, cut, and printed in a clean-room environment. The date of extrusion was clearly marked on each piece, ensuring full traceability. This not only satisfied regulatory requirements but also gave our customer greater control over inventory management. Our flexible production capabilities allowed us to produce tubing in small batches, ensuring that the parts remained freshly extruded and well within their recommended shelf life. This approach minimized waste and helped maintain the high standards expected by the customer.
Additional Support For Secondary Processes
At Colosilicone, we don’t just stop at providing the core product; we also offer comprehensive support for secondary processes. In this case, our Application Engineering team worked closely with the customer to fine-tune the secondary processes, such as tipping and assembly of the tubing. The goal was to ensure that the tubing and the tube fittings were perfectly compatible, eliminating issues like buckling at the joints.
Through careful adjustment of thermal forming techniques, we were able to eliminate flow restrictions and kinking, both of which could affect the tubing’s performance. By ensuring that the connections between the tube and fitting were secure and reliable, we helped improve the overall functionality and safety of the medical device.
Why Choose Colosilicone?
At Colosilicone, we pride ourselves on offering not just products but full solutions. Our extensive expertise in medical-grade tubing manufacturing ensures that we can meet even the most demanding requirements of the medical device industry. From selecting the right materials to optimizing production processes and ensuring traceability, Colosilicone is committed to providing the highest level of service and quality.
Our factory operates under strict quality control standards, including ISO certifications, and we specialize in custom solutions for our clients. Whether you require tubing for a class II medical device, need help with material selection, or want to fine-tune secondary processes like assembly, Colosilicone is your trusted partner.
Our team is always ready to work closely with you to address any challenges, providing timely and efficient solutions that reduce risks and improve the quality of your product. At Colosilicone, we don’t just manufacture tubing—we help you achieve success in your medical device development process. For more information or to discuss how we can support your specific needs, contact us today. We look forward to collaborating with you on your next project.