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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
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.
- 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
- Prototyping
- 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 Services
From package design to sterilization validation and manufacturing scale-up, J-Pac has the expertise to get you to market faster.
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
FAQs
Learn more about medical device packaging, validation, and design by reading a few of the most common questions we hear from our customers.
Should the medical device packaging performance qualification (distribution simulation) be done at the same time as the product stability study?
Package Seal Test
Pull test of a medical package seal to evaluate the strength and integrity of the seal.
No. ISO 11607-1 Section 6.4.4 indicates that stability testing and performance testing are separate entities.
Stability testing is testing the sterile barrier system. The stability test will demonstrate the shelf life of the sterile barrier irrespective of what is inside the package.
Performance testing is testing how the packaging system responds to shipping and handling stresses. The performance test must demonstrate that expected shipping stresses do not compromise the sterile barrier.
How does J-Pac perform a cleaning validation?
Pre-validated medical device package with double barrier
Pre-validated sterile package, including nested rigid trays and flexible urethane inserts that allow multiple components to share the same package.
J-Pac uses approved protocols for all validations, including cleaning. The medical device cleaning validation is designed to show that contaminants that come in contact with the product during manufacturing and packaging are safely removed. These contaminants include organic residues (such as oil), inorganic residues (such as leftover particulates from processing), and microbiological contaminants (such as bioburden from inadequate operator hygiene controls).
The key components of the validation are:
- Process FMEA to determine possible sources of contaminants, including suppliers that touch the device
- Benchmarking non-cleaned parts
- Establishing acceptance criteria
- Grouping of samples by material type/family, cleaning process
- Identification of worst-case conditions to test
- Establishing a statistically rationale sample size
- Establishing the cleaning process steps and parameters
- Post cleaning testing
- Establishing Alert and Action Levels
- Establishing post validation sampling plan and change control plan
What is ISO 11607?
Automated Blister Manufacturing
High volume blister manufacturing line. Film is thermoformed and sealed with a foil lidding material. Multiple blister wells are vacuum tested real-time with the line running at 20M units per year.
ISO 11607 is the standard for packaging terminally sterilized medical devices and is comprised of two parts.
ISO 11607-1:2006 specifies the requirements and test methods for materials, preformed sterile barrier systems, sterile barrier systems, and packaging systems that are intended to maintain sterility of terminally sterilized medical devices until the point of use.
ISO 11607-2:2006 specifies requirements for development and validation of processes for packaging medical devices that are terminally sterilized. These processes include forming, sealing, and assembly of preformed sterile barrier systems and packaging systems.
Part 1 addresses Materials and Design while Part 2 addresses Packaging Process Validation. These are both required to satisfy the Essential Requirements of the European Directives to achieve CE Marking. Additionally, this guidance document is recognized by the FDA and used for premarket review submissions.
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Let’s Get Started.
A conversation with J-Pac is your first step to having a manufacturing partner you can count on.