A Turnkey Medical Device Outsourcing Partner for Single-Use Medical Devices
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
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.
- Experience serving large and small OEMs
- ISO 13485:2016 certified
- FDA registered
- Class 7 and 8 cleanroom assembly
- Dryroom for bioabsorbables
- Medical device packaging design and validation to ISO 11607
- Sterilization validation
- Shelf life validation
- Manufacturing IQ/OQ/PQ
- ERP traceability and lot control
- In-house tooling
- In-house package thermoforming
- 3D printing
- Manufacturing automation
- Supply chain management
- Lean manufacturing
- ERP system
- Broad array of assembly processes
- Broad array of packaging formats including rigid and semi-flexible packaging, pouches, mounting cards, and gas flushing
- Label design
- Dual sourcing and nearshoring
- Raw material and finished good inventory management
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.
Learn more about medical device packaging, validation, and design by reading a few of the most common questions we hear from our customers.
What tests are used for a cleaning validation?
Tyvek clear film peel pouch. The clear film allows visibility to the device while the Tyvek enables Eto sterilization.
Typically, testing covers three areas:
- Cytotoxicity: a test for overall safety, measuring if the device material or residuals are cytotoxic.
- Bacterial Endotoxin: a test of harmful endotoxin contamination, which is typically introduced by water and can be very dangerous to patients.
- Bioburden: a test of fungal or bacterial contamination.
What medical device testing has to be done under worst-case conditions?
Automated Packaging Line
Automated packaging line that seals medical foam into a four-sided sterile package.
ISO 11607-1 Section 6.3.4 states, “Performance testing shall be conducted on the worst-case sterile barrier system produced at the specified process limits of forming and sealing and after exposure to all the specified sterilization processes.”
The Performance Test includes the simulated distribution test and is a separate test from the sterile barrier stability study. In practice, the most typical “worst-case” manufacturing conditions are related to variables affecting seal strength. However, there is no formal definition provided by the standard. It is up to the manufacturer to define “worst-case” manufacturing conductions.
What package design services does J-Pac offer?
Medical Tray Carton
Packaging carton for a sterile device package. E-flute designs can eliminate the need for shipper boxes in some circumstances.
J-Pac offers a turnkey ISO/FDA compliant medical device package design and validation process that can be integrated into your technical files.
- We start with documenting customer requirements for their medical device package, which includes usability issues and aseptic transfer requirements, as well as labeling preferences.
- Next, we document the packaging system requirements that consider storage and transportation conditions, cleanliness, bioburden, and expected environmental stresses and constraints. Sterility methods and material compatibility are also assessed at this time.
- Based on these inputs, we design both the medical device sterile barrier system that will prevent microbial contamination and the protective packaging that will protect both the product and the sterile barrier system during shipment.
- Next, we manufacture prototypes under worse-case manufacturing conditions and test the feasibility of these designs in our in-house lab to ensure a high probability they will pass simulated distribution testing.
- Once the customer approves the medical device packaging prototypes, we can test usability with our panel of surgical nurses to ensure we meet the requirements for usability.
- All of this medical device package design work will be conducted under an ISO 13485 quality system including requirements specifications, test protocols, validation plans, and test reports and these are provided to the customer for their technical files. We also manage all outside testing services.
Let’s Get Started.
A conversation with J-Pac is your first step to having a manufacturing partner you can count on.