Our Core Competencies for Medical Textiles
What can J-Pac Medical do for you?
J-Pac Medical has a breadth of competencies that allow us to tackle even the most challenging implantable textile device projects from start to finish. With J-Pac, every stage of development, manufacturing, and packaging is backed by our rigorous quality management and validation processes to provide assurance of a high quality end product.
3-D Forming of Biomedical Textiles & Films
Cutting and Edge Treatment Techniques
Traditional cutting processes may allow the ends of textiles to fray, making the edges of the implant rough. We utilize high-precision cutting and edge treatment techniques that produce semi-sealed edges resulting in particulate reduction. This creates smoother, more flexible, cleaner implants which may support improved tissue passage characteristics and significantly benefit both the patient and surgical team, and aid in meeting surgical hand requirements.
Our custom edge treatment processes:
- Optimize edge quality of implantable medical textiles, which may minimizes tissue inflammation and scar tissue formation
- Define/ reinforce the edge to enhance stability and suture pull-out
- Improve device delivery through cannula
- Enhance ease of tissue passage
- Advance manufacturability of the finished device, which reduces component prep time within the overall device assembly process
Dry Room Processing
Any of J-Pac Medical’s textile processing competencies can be performed within our on-site dry rooms. Our dry room capabilities are tailored for manufacturing and packaging flows that incorporate absorbable polymers, lyophilized materials supporting implantation or diagnostic testing, and any production flow reliant on low humidity processing and modified atmosphere packaging.
We conduct low humidity processing in Class 7 clean rooms with options for both low and high volume applications, which enables us to process and package environmentally-sensitive healthcare products. The low humidity environment extends the WIP Time (Open Exposure Time) for materials and components that are moisture sensitive, limiting the risk of overexposure to humidity that can negatively affect shelf life and efficacy.
For low volume dry room processing, our custom fabrication rooms are maintained at less than 30 percent relative humidity (RH) and feature modified atmosphere pouch packaging (nitrogen and CO2), a nitrogen storage chamber and a nitrogen drying oven. Low volume dry room processing is ideal for applications that include surgical and intravascular implants that incorporate drug components or absorbable polymer. These products are typical in the sports medicine, trauma, orthopedics, wound management, tissue replacement, plastic surgery, neural and endoscopy market segments.
A more spacious dry room is also available to house higher volume flows and is maintained at <20% RH.
Assembly and Bonding Processes
The J-Pac Medical team has the expertise required to work with many different kinds of materials – even hard to handle materials. We have the capabilities to join dissimilar materials without cyanoacrylate and can incorporate multiple materials in to a single device for an optimized implant.
We utilize a variety of energy-driven activation methods to enable assembly of thermoplastic components without the need for solvents, glues or adhesives. Our activation methods can include thermal conduction, convection, and radiance, as well as Ultrasonic and Radio Frequency. As a result, J-Pac can reduce the process variability commonly seen in glue or solvent assembly and eliminate most chemical residual concerns, which is particularly critical for surgical implants. The appropriate method is custom selected in conjunction with each customer’s specific material and design considerations in order to develop the optimal assembly solution for every application.
We also save our customers considerable time in performing sewing and suture tying.
Cutting and Tipping
J-Pac Medical is home to extensive experience in laser cutting for a broad range of substrates in Class 7 clean rooms. This is a fast and accurate cutting method that does not require a tooling investment by our customers. The process is driven by programming and is applicable to any applications where oxidation of the cut substrate is not a concern.
We have capabilities to create layered constructs within our laser cutting process, which is particularly beneficial for tissue scaffold applications.
We also perform potting of textile “ends” to eliminate unraveling and tipping for threading and termination.
J-Pac Medical is an optimal partner for customers that require a delivery vehicle for the localization and controlled release of a pharmaceutical or active agent. Our experts work in close collaboration with customers to ensure that innovation and quality serve as a foundation for the thoughtful processing of polymers that are embedded or coated with the required therapeutic materials. Our capabilities such as 3-D anatomical shape forming, unique geometries, and edge treatment techniques enable the precise placement of drug & device combination products, while minimizing tissue irritation.
We are DEA registered to handle Schedule III Active Pharmaceutical ingredients, providing the added assurance we will be able to handle all of your drug & device combination needs to deliver treatment-enhancing drugs while maintaining strict regulatory compliance.