Contract Packaging of Single-Use Surgical Kits

A Turnkey Medical Device Outsourcing Partner for Single-Use Medical Devices

Sterile Medical Device Contract Packaging

J-Pac Medical is the complete outsourcing partner for all your sterile medical device assembly, packaging, and sterilization.

J-Pac manufactures single-use, Class II & III sterile medical devices including, surgical devices, implantable textiles, and diagnostic consumables for both large and small OEMs. We manage your product realization through a robust ISO 13485 Quality Management System, giving you a complete medical device contract manufacturing solution.

The Right Medical Device Outsourcing Partner from Start to Finish

J-Pac recognizes that you are challenged to develop better products, achieve faster time-to-market, and lower total cost. Yet your resources are becoming more limited, requiring you to do more with less.

The back-end product realization processes required to launch a medical device are the single biggest cause of delays because they require complex and highly regulated processes that take more time than expected.

J-Pac’s medical device outsourcing model results in faster and less expensive product launches by executing the backend headaches of package design, sterilization validation, shelf life testing, and manufacturing scale-up in parallel to product design.

A Better Outsourcing Model for Better Results

Our expertise is in the back-end of product development. We know what needs to be done, how long it will take, and how it can be best integrates with your design process to reduce time and costs.

Dependable | Trustworthy | High Quality

Dependable, trustworthy, and high quality – these are the words our customers use when describing J-Pac. This is the result of our company culture, management leadership, and robust quality system.

Clear communication and collaboration are crucial to success. While you have a dedicated project manager who coordinates your program schedule, our experience has taught us that speed requires communication at multiple levels. We are an extension of your company and our process is designed to give you direct access to the hands-on people at J-Pac who get stuff done: engineers, quality specialists, and manufacturing management.

Medical Device Outsourcing Capabilities and Expertise

Unlike other medical device contract manufacturers, our capabilities and expertise are not beholden to any one medical device technology. Our expertise is applicable to most any single-use medical device.

In-house tooling made with CAD CAM CNC

Medical Device Assembly & Packaging Services

From package design to sterilization validation and manufacturing scale-up, J-Pac has the expertise to get you to market faster.

Cleanroom assembly using ultrasonic welding

Medical Device Assembly & Packaging Products

Our capabilities apply to a broad spectrum of consumable, single-use medical devices comprised of multiple plastic and metal components, assembled, tested, packaged, and sterilized.

Helpful information about Medical Device assembly & packaging

White Papers

Read White Papers written by the experts in Medical Device Assembly & Packaging.

Product Sheets

Download the details you need about Medical Device Assembly & Packaging products and services from J-Pac Medical.

FAQs

Learn more about medical device packaging, validation, and design by reading a few of the most common questions we hear from our customers.

Do orthopedic implants need to be double packaged?

Nested Trays

Nested Trays

Double barrier thermoformed trays that nest into each other. Each tray will be sealed with Tyvek.

There is no regulatory requirement for double packaging orthopedic implants but there are several factors and requirements of ISO 11607-1 that influence the decision. Section 6.2.2 requires that the medical device package allow the product to be presented in an aseptic manner. While this does not require a double package design, some surgeons prefer to have a “belt and suspenders” approach where the inner package prevents any unnecessary contact while sitting in the sterile field. Additionally, many circulation nurses prefer the ability to transfer the device to the sterile field without waiting for someone in the field to take it out of the package. A double package design can facilitate this - often called “dumping,” “throwing,” or “dropping,” by OR nurses. Additionally, the standard section 6.1.1 requires that the package protect the safety of the user and patient. Some medical device implants have sharp features that may make a double package design desired. Lastly, the issue may come down to surgeon preference.

How do you validate medical device packaging?

Pre-validated, Double Barrier Packaging

Pre-validated, Double Barrier Packaging

Pre-validated nested double barrier packaging with custom urethane insert.

Packaging validation is complex. There are several processes that must be completed

  1. The manufacturing process to produce the packaging’s sterile barrier system must be validated. This requires an Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) to be conducted on the manufacturing equipment.
  2. Packaging performance testing must be completed. This includes manufacturing and sterilizing under worst-case conditions and subjecting the packaging system to simulated distribution testing.
  3. A stability study must be completed and is typically done with both accelerated and real-time aging studies.
  4. Both the performance testing and stability study require tests for seal integrity and seal strength as well as an evaluation of product protection.

Does J-Pac perform post-thermoforming customization of medical grade trays?

Catheter Tray Package

Catheter Tray Package

A surgical catheter packaged in a thermoformed tray. The tray was designed with a clear lid that snaps into place. The customer wanted the tray to be pouched.

Thermoformed medical device packaging trays are customized to incorporate various types of venting to support lyopholization processes and/or Eto processing of resorbable polymers. Additionally, reverse flanges can be provided for large trays that are designed to accommodate heavy materials.

Sterilized implantable medical textile for hernia repair formed from polypropylene mesh

Medical Textiles

Custom formed and particulate-free biomedical textiles for medical devices and allograft processing

Cold formed reagent blisters mounted on a microfluidic diagnostic consumable

Diagnostic Reagent Blisters

Partner with J-Pac Medical to produce your custom diagnostic reagent blisters to speed processing and reduce errors.

Latest News

May 20, 2021


Breaking down barriers to scale up medical device manufacturing

Call Our Engineers Now

603.692.9955

somersworth@j-pacmedical.com