Derek Laffey, Global Market Manager at Teknor Apex discusses how the company is committed to innovation and excellence in the world of polymers, and introduces the new product line that was launched at COMPAMED 2024.
As we celebrate our 100th anniversary in 2024, Teknor Apex remains committed to pushing the boundaries of polymers. Our journey has been marked by a relentless pursuit of excellence, working closely with our customers to develop innovative solutions that advance the life sciences and medical device industries.
A Legacy of Partnership and Innovation
For decades, Teknor Apex has been a trusted partner to the healthcare industry. Our deep understanding of the unique challenges and stringent regulatory requirements has enabled us to deliver tailored polymer solutions that meet the highest standards of quality and performance.
By leveraging our expertise in multiple polymer technologies, including polyvinyl chloride (PVC), thermoplastic elastomers (TPEs) and engineered thermoplastics, we offer a comprehensive range of materials that address a wide array of healthcare applications.
Teknor Apex
The Apex, Flexalloy, and Medalist Families
Our industry leading product lines - Apex, Flexalloy, and Medalist - have become synonymous with reliability and innovation. These families offer a diverse range of both general use and application-specific materials, each with its own unique set of properties and benefits.
- Apex: Our flagship PVC brand, Apex offers the widest range of non-DEHP compounds on the market. With superior clarity, lot to lot consistency, and excellent radiation sterilization characteristics, Apex grades are ideally formulated for critical device components like IV, blood therapy, enteral feeding and airway tubing, as well as for molded components like connectors and luer locks.
- Flexalloy: High-performance PVC elastomers provide exceptional strength, durability, and flexibility for demanding medical device applications like pump segment tubing or any component demanding a higher level of performance beyond the limits of standard PVC.
- Medalist: Our diverse families of TPEs are excellent alternatives to silicone and other high-price materials, offering flexibility and rubber-like elasticity. Medalist TPE’s offer excellent clarity and can be recycled, setting them apart from other less versatile materials.
The Medalist MD-90000 Series: A New Era of BioPharma Tubing
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The recent launch of the Medalist MD-90000 Series at COMPAMED marks a significant milestone in our commitment to advancing biopharmaceutical tubing solutions. This innovative product series aims to solve a unique challenge in biopharma tubing: exceptional clarity with low spallation. For those who may be wondering what spallation means, it is the dislodging of small granules of tube material as the rollers of a pump wear away the outer wall of the tube, pass after pass. The tube breaks down due to this loss of material, causing it to weaken and eventually fail. The tiny particles of tubing that are scraped off can build up in and around the pump in a measurable amount. Spallation can lead to tubing failure regardless of the plastic material and can create microplastics, a growing problem the industry is actively working to address.
Most low-spallation materials are opaque, meaning designers are forced to make a tradeoff when it comes to pump tubing material selection whereby clarity is sacrificed for spallation performance. Working closely with a key supplier, Teknor’s R&D team iterated through various formulation cycles to land on two new grades that offer industry-leading spallation performance coupled with unbeatable clarity. The MD-91760 and MD-91970 set a new standard for TPE tubing materials, meeting the highest level of pump performance without sacrificing clarity and avoiding the wear and failure observed with previous generation TPE products. In addition, these compounds offer improved compression set and, unlike silicone, can be easily recycled. In the coming months Teknor plans to release a fresh round of test data that will demonstrate the exceptional performance of MD-91760 and MD-91970 post-gamma sterilization, as well as a full package of data around burst strength, welding and heat sealing, and low temperature performance.
A Collaborative Approach to Innovation
Our success is rooted in our collaborative approach to innovation. We work closely with our suppliers to integrate the latest advancements in polymer technology into our compounds. By leveraging their expertise, we can develop cutting-edge solutions that meet the evolving needs of the medical device and biopharmaceutical industries.
Partnering for Success
To further strengthen our partnerships with customers, we have established a network of Application Development Centers of Excellence. These state-of-the-art facilities provide a collaborative environment where customers can work side-by-side with our technical experts to develop and optimize their products. Equipped with advanced processing equipment, our centers allow customers to test their formulations and applications under real-world conditions, accelerating time-to-market.
A Commitment to Quality
Our commitment to quality is unwavering. Our world-class quality laboratories are staffed with highly skilled technicians and equipped with advanced testing equipment. From mechanical testing to chemical analysis, we rigorously evaluate the performance of our materials to ensure they meet the highest standards of quality and reliability. By maintaining strict quality control measures, we deliver consistent and reliable products that meet the demanding requirements of the healthcare industry.
Navigating the Complex Regulatory Landscape
The healthcare industry is subject to a complex and ever-changing regulatory landscape. One significant development in recent years has been the global phase-out of Di(2-ethylhexyl) phthalate (DEHP) due to concerns about its potential health risks.
Teknor Apex has been at the forefront of this regulatory shift, developing innovative, non-DEHP formulations that meet the stringent requirements of the healthcare industry. By leveraging our deep understanding of polymer science and our strong relationships with suppliers, we have been able to successfully transition our product portfolio to comply with these new regulations.
Our regulatory team has worked tirelessly to ensure that our products meet the latest standards and certifications. By staying ahead of the curve, we have helped our customers avoid costly product recalls and regulatory compliance issues.
Conclusion
As we look to the future, Teknor Apex remains committed to driving innovation and delivering superior polymer solutions to the healthcare industry. By leveraging our deep expertise, collaborative approach, and unwavering focus on quality, we will continue to shape the future of healthcare for generations to come.
