Medical Grade Textiles FAQs
Do you have capabilities for handling bioabsorbable implants?
Yes. J-Pac Medical is uniquely qualified to handle bioabsorbable implants. We have low humidity cleanrooms for biomaterial device 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 biomaterial and textile providers that can provide medical grade textile materials. J-Pac Medical provides cutting, shaping, assembly, packaging, and sterilization of these materials to provide a turnkey service for its customers.
What polymers are most common in biomaterials 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 implantable biomaterials are converted at J-Pac Medical?
- 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?
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.
Biomaterials can degrade quickly. How can J-Pac help?
Absorbable biomaterials degrade when exposed to moisture and heat. This can be significant when devices undergo the total cycle from manufacturing, packaging, transport to sterilization, and exposure to sterilization humidity and elevated temperatures. J-Pac has a unique process designed to mitigate these issues. Cleanroom assembly is conducted in a special humidity-controlled cleanroom. EtO sterilization in completed in-house and with lower temperature cycles. Once sterilized, the biomaterial devices are quickly packaged, dried or gas-flushed, and sealed. A process that normally takes weeks can be done in a few days.
What assembly processes can be performed for biomedical textile implants?
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