FAQs

Company

How experienced are you in the medical device industry?

J-Pac Medical has been in business since the late 1970s. We focus exclusively on medical and diagnostics.

How large is J-Pac?

We operate in a 60,000 s.f. freestanding manufacturing building, which houses 11 cleanrooms. We ship globally. J-Pac has additional cleanroom manufacturing in Costa Rica.

How do you support your customers?

We have an Innovation Services group that is dedicated to helping customers through all phases of the process, from determining requirements through transfer to manufacturing. You will be assigned an engineer to assist you. Once your program is in production, you will be serviced by our customer service team.

Do you work with small companies?

Yes. We work with both large and small companies, including start-up companies that are funded.

Quality

Cleanrooms

Does J-Pac Medical have cleanroom capabilities?

We utilize eleven class 7 and class 8 cleanrooms by customer to maintain confidentiality and control. We also have a dry cleanroom where we can control temperature and humidity for sensitive products.

How are cleanrooms monitored?

Active cleanrooms are monitored monthly for non-viable particulates and quarterly for viable particulates. The cleanrooms are certified annually and our laminar flow hoods are certified semi-annually. Employees and service providers to these rooms follow internal procedures on gowning and how to properly transfer materials to and from the cleanroom. Airborne particle counts ISO 14644-1. We actively trend all of our data and maintain alert and action levels specified in ISO 14644-1.

Controlled Substances

Does J-Pac have the ability to purchase prescription components?

J-Pac Medical maintains a Board of Pharmacy Certificate, which allows us to purchase prescription drug and devices to be incorporated into customer devices.

Change Implementation

How fast can changes be made in your system?

For urgent situations, changes can be implemented the same day as the request, as long as it does not impact the supply chain.

Sterilization

Can J-Pac sterilize our product?

J-Pac does not sterilize product onsite but we do have several sterilization houses on our approved supplier list and will work with you to determine which one best suits your needs.

Are you able to perform additional testing required for product releases such as endotoxin or bioburden?

While J-Pac Medical does not perform the actual testing of the samples we do have a laboratory that is on our approved supplier list that performs any required test.

Regulatory

Are you FDA registered?

Yes. Our FDA registration number is 1221051.

Are you ISO certified?

Yes. We are certified through BSI to ISO 13485:2016. Our certification number FM 66316.

Label Control

How do you control labels?

We manage all label functions in one secure area. We handle labels both provided by customers and printed on-site. We have a label accountability process that accounts for every label in stock.

Manufacturing

What type of material can you form on your tray thermoforming process?

Our commonly used materials include PVC, PET/PETG, styrene, High Impact Polystyrene (HIPS), polycarbonate (Lexan), polypropylene, as well as other unique and specialized materials. Our engineering team and plastics partners are able to assist in the development of packaging utilizing unique properties and characteristics specific to your application. Our thermoforming processes are capable of both thin-film and thick-film applications, in continuous roll feed as well as single sheet format.

How do you manage your supply chain?

J-Pac Medical utilizes a network of top-tier suppliers to the medical device industry, ensuring the highest quality components for a variety of applications. Our suppliers are thoroughly vetted and qualified to stringent Approved Supplier List standards, compliant to FDA and ISO 13485 standards for supplier qualification. Our Total Package approach to supply chain management ensures efficiency in pricing, quality, and service to our customers.

How efficient are your operations?

J-Pac Medical utilizes a system of Lean Manufacturing to manufacture and package our medical devices and components. This approach to manufacturing, eliminating waste, and driving the responsibility and ownership of quality and reliability down to the Operator level, ensures that all products are produced correctly to specification, the first time, every time. Our Lean Manufacturing culture also focuses on the elimination of complexity, ensuring that processes are intuitive and documented for consistency and reliability. Our teams are measured against Key Performance Indicator metrics, ensuring performance alignment to customer expectations and specifications and ensuring that issues are addressed real-time, at the point of operation.

Medical Grade Textiles

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.

Call Now

603.692.9955

info@j-pacmedical.com