The medical device packaging design, testing and validation process is complex and time-consuming. It also undergoes intense regulatory scrutiny and is the largest cause of FDA recalls. Medical device packaging is often started too late in the design process, posing significant challenges for most new product launches.
J-Pac Medical is a turnkey assembly and contract packaging & sterilization provider of Class II and Class III sterile medical devices for small, new-entrant companies and large OEMs alike.
Medical device packaging capabilities
We take ownership of the following medical device assembly & packaging processes so you don’t have to:
- Sterile medical device packaging design and validation
- Medical device contract packaging
- Class 7 and Class 8 manual and automated cleanroom assembly
- In-house tooling design and fabrication
- Medical and diagnostic device assembly and packaging process development and validation
- Material sourcing and supply chain management
- Cleanroom thermoforming
- Secondary medical device packaging flows, including GS-1 labeling
- ISO 11607 medical device packaging sterilization process validation
- Documentation to meet FDA 510(k) and ISO 13485 quality management system requirements
Essential reading for medical device manufacturers
See the full scope of value J-Pac Medical can add to your program by reading these in-depth resources:Establishing shelf life of medical devices Validating medical device assembly, packaging & sterilization
Medical device packaging product examples
J-Pac’s turnkey services take disposable medical device packaging off your critical path and contribute to an easier, faster product launch.
We support a wide array of sterile single-use medical device packaging formats, including:
- Flexible form/fill/seal
- Thermoformed trays
- Tyvek LDS
- Mounting cards
- Resorbable/bioabsorbable implants
- Surgical, diagnostic and procedure kits
- Pre-validated packaging
- Peelable pouches
- Header bags
- Drug-device combinations
- Carton shippers
In addition, we perform post-forming fabrication for packaging with vents, handles, locking tabs and welded internal components. We also provide custom trays to support unique lyophilization processes.
Today’s FDA and ISO regulations require dozens of separate protocols and test reports to validate that a package protects its device and stays sterile from factory, storage, distribution, and aseptic transfer to the end-user. The regulations are complex and often lead to compliance issues, recalls, and, in the worst cases, patient harm.
J-Pac’s package design and validation services include:
Smart design starts with understanding what package formats achieve the necessary levels of cleanliness and sterility. We balance protection, ease of use, and material costs.
Virtual package photos
We will provide you with a photorealistic rendering that is indistinguishable from the real thing and much quicker.
J-Pac uses rapid prototyping processes and quick change thermoforming equipment.
Our sterile field experts will ensure that the contents of the package can be aseptically transferred into the sterile field, meeting ISO 11607 and FDA regulations.
We minimizing material and transportation costs while assuring your entire packaging system, including carton, maintain sterility during distribution and storage to meet ISO 11607 regulations.
DHR ready validation protocols and reports
We provide you with all the unique protocols and reports of your packaging validation for your technical and regulatory files.
Simulated distribution testing
We save you time, money, and headaches by working closely with accredited testing labs for final testing. We conduct internal feasibility tests prior to conducting a simulated distribution study to ensure the package passes the test the first time.
Shelf life stability studies
We will design and execute studies that meet the ISO guidelines for stability and shelf life in the fastest possible time.
Before developing the assembly process, we conduct a DFM review of the product to determine the most efficient way to assemble it. The assembly process is then developed according to the commercialization requirements of the customer.
Assembly and packaging processes are validated based on the established critical specifications. Assembly processes undergo a formal process including Installation Qualification, Operational Qualification and Performance Qualification. Our Performance Qualification process involves running multiple separate lots over multiple production operators, shifts and raw material lots to ensure all processes are capable.
A new medical device contract manufacturing program is transitioned into manufacturing using a formal process that includes a team of representatives from quality, manufacturing, engineering and purchasing. The team follows strict guidelines to ensure all the documentation, routers, procedures and validations are successfully completed prior to transition.
Medical device cleanroom assembly and packaging production is conducted using lean manufacturing processes that ensure efficiency, quality, and accountability. Small teams of trained employees with an accountable group leader ensure the manufacturing processes are followed.
J-Pac helps your business be successful by matching the right sterilization partner with your specific needs. We work with you to determine the factors that best fit your current needs as well as future growth.
J-Pac offers in-house EtO contract sterilization for small to medium volume production.
Considerations we take into account when selecting the right sterilization company for a project:
We work with 3rd party consultants that are experts in the field to help you determine the appropriate sterilization method for your device.
Sometimes the selection of the sterilizer can be sensitive to location due to the number of loads required and transportation costs.
Since we work with many customers and products, we have keen insight into which sterilization supplier can meet your lead time requirements.
J-Pac can recommend sterilization companies that can provide the appropriate amount of chamber equivalency.
We can provide guidance to best balance your budget with capabilities.
J-Pac performs sterilizer supplier audits so you don’t have to.
Some sterilization companies are a better fit for your needs than others. J-Pac can help you navigate this important part of your process.
J-Pac believes that excellent medical device outsourcing requires comprehensive supply chain management. We will assure your product meets all regulatory requirements and provide the right mix of compliant processes, quality, and reliable availability.
We give you resources
By having J-Pac manage your supply chain, you get the benefit of our purchasing, engineering, quality, and management resources.
We sweat the details
We will purchase raw materials on your behalf. We audit suppliers through our ISO 13485:2016-compliant procedures. We track your specialized tooling and molds and coordinate with you when changes are needed. We handle the day-to-day issues so you don’t have to.
You become more nimble
When J-Pac manages your supply chain, you become more agile and can modify production requirements much easier than you can with in-house manufacturing.
We minimize risk
We manage variables that could cause compliance and delivery issues.
J-Pac is a medical device contract manufacturer large enough to meet your needs but small enough to respond lightning fast.
We know which suppliers are best for your product
When we handle supply chain management, you only deal with us as a single supplier, yet we have the flexibility to use multiple suppliers that are best for your product.
Medical device sterilization services
J-Pac Medical provides EtO, gamma and E-beam sterilization, including validation and final lot release. Learn more about our device sterilization capabilities here.