Medical Grade Textiles FAQs
Do you have capabilities for handling bioabsorbable implants?
Yes. J-Pac is uniquely qualified to handle bioabsorbable implants. We have low humidity cleanrooms for assembly and packaging and offer unique formats to minimize moisture exposure during the sterilization and transportation processes.
What is a medical grade textile?
Medical grade textiles have minimally been tested for hemolysis, cytotoxicity, and intracutaneous reactivity. The materials are lot controlled and have full raw material traceability. A Certificate of Compliance is provided with each shipment of product to our customers.
Does J-Pac Medical make the textiles that it converts into products and implants?
No. J-Pac Medical works with all textile providers that can provide medical grade textile materials. J-Pac provides cutting, shaping, assembly, packaging, and sterilization of these materials to provide a turnkey service for its customers.
What polymers are most common in the textile constructions that J-Pac Medical works with?
The most common polymers are Polypropylene (PP) and Polyester (PET), although Polyethylene (PE) and Polytetrafluoroethylene (PTFE), and absorbable polymers are also processed. These can be in the form of textiles but are also in the form of injection molded components. Absorbable Polymers include lactide/glycolide combinations and Polydioxanone (PDO), as well as others.
What formats of textiles are converted at J-Pac Medical?
J-Pac Medical primarily works with Braids, Weaves, Knits, and Non-woven Structures.
- The braid materials are typically multifilament strands that are used broadly in sutures and sports medicine applications.
- Woven materials are fabrics that are dense (low pore size) and are dimensionally stable in all directions. These are typically used in wound care and critical filtration applications.
- The knitted materials are more open structures (larger pore size) that typically display a stretchy direction and a stable direction. These are used in soft tissue repair applications as well as filtration applications.
- The Non-woven materials are dense and strong. These materials are used broadly as tissue protecting sewing rings or pledgets in a broad range of cardiovascular applications.
What is particulate-free cutting?
Steel rule die cutting of medical grade textiles can provide unwanted fracturing or particulate generation. J-Pac Medical offers cutting methods that are housed in Class 7 cleanrooms and provide cut parts that are free of cutting-generated particulate. This is very important considering many of the components that we cut are destined to be surgically implanted or are utilized in critical filtering processes.
Does J-Pac Medical have textile implants available for sale?
No, J-Pac Medical has no products of its own. Textile implants are built to our customer’s specifications and the design history file (DHF) resides with our customer.
What is edge treatment?
When woven or knitted textiles are cut, the integral construction of the fabric is broken and the construction can begin to unravel. Edge treatment processes offered by J-Pac Medical recreate an unbroken edge at the point of cutting that will maintain the original fabric construction and stop any fraying. The created edge also improves handling in surgery and improves tissue passage.
What is tipping?
When braided strands are cut with typical processes, the multi-filament construction will unravel from the point of cutting. Tipping methods provided by J-Pac Medical maintain the braid construction at the point of cutting.
See the latest news and resources from J-Pac. It may help you in your next medical device outsourcing project
Let’s Get Started.
A conversation with J-Pac is your first step to having a manufacturing partner you can count on.