What market verticals do you serve?
We focus on medical device outsourcing for single-use devices, absorbable and nonabsorbable implants, and Invitro diagnostic reagent blisters and consumables. Our cleanroom assembly packaging and sterilization capabilities are broad. Our focus is not on any one technology or market application. We are an integrator that pulls all the medical components together to assemble, package, and sterilize single-use devices, biomaterial implants, and diagnostic reagent blisters cartridges.
What is your production capacity?
Medical device cleanroom assembly line
Medical device assembly automation
J-Pac has three ranges of production capacity for lab-on-a-chip reagents. Our lab can supply small volumes of less than 5,000 units. Our semi-automated production lines can produce up to 5 million units per year. Our automated lines can produce more than 30 million units per year.
What makes J-Pac different than other contract manufacturers?
J-Pac is focused on customer service at all levels of our medical device contract manufacturing relationship with our customers. We focus on speed, responsiveness, and dependability. We consider quality and on-time delivery to be nonnegotiable and believe that our high levels of customer service set us apart. Additionally, for the medical device contract manufacturing markets we serve, we are “turnkey,” which means we handle the complete supply chain and serve as a one-stop solution as an external manufacturer.
In addition to being a service-focused medical device outsourcing company, our manufacturing systems have been optimized for medical device assembly and packaging. Other medical device contract manufacturers try adding assembly as an additional service to their core manufacturing capability. At J-Pac our core competency is medical device assembly. Component materials can come from various best-in-class suppliers, who we manage for our customers.
How experienced are you in the medical device industry?
How large is J-Pac?
J-Pac manufacturing plant
Medical device contract manufacturing facility
How do you support your customers?
We have a Customer Program Management Team that works with our Engineering and Manufacturing teams to guide customers through all phases of the process, from determining requirements through transfer to manufacturing. You will be assigned a dedicated program manager at the start of your project. Once your program is in production, you will be serviced by our sales and customer service team.
Do you work with small companies?
What kind of medical device manufacturing and cleanroom assembly processes do you perform?
J-Pac Medical has a broad array of medical device assembly processes required by many of today’s medical and diagnostics devices. Our capabilities include RF and ultrasonic welding, thermoforming, die cutting, laser cutting, solvent bonding, sewing, laminating, liquid and solid filling, plus many others. All of our manufacturing processes are geared toward manufacturing and assembly of single-use medical and diagnostic devices containing multiple thermoplastic components. We have Class 7 and 8 cleanrooms as well as a dry cleanroom (<35% RH) for moisture sensitive devices. These assembly capabilities are applied to Class II and Class III medical devices, biomaterial implants, and microfluidic IVD reagent blisters.
Where is J-Pac Medical located?
The corporate, engineering and US-based manufacturing facility is located in Somersworth, NH. Offshore manufacturing is performed through our Cartago, Costa Rica facility. These two state-of-the-art facilities total 70,000 square feet of manufacturing space and offer a total of twelve clean rooms, including ISO Class 7 Clean Rooms and ISO Class 8 Clean Rooms. These clean room areas include rooms that provide low humidity medical device cleanroom assembly environments, as well as a solvent scouring room for the processing of bio-resorbable polymers.
How does J-Pac’s medical device outsourcing process improve an OEM’s speed to market?
J-Pac expedites the speed and quality of medical device outsourcing through its unique product realization process, consisting of an efficient and FDA compliant pathway customized for each medical device company’s unique needs. The pathway consists of a Product Realization Plan with key phases including Requirements Finalization, Design Transfer, Process Feasibility, Development, Validation, and Manufacturing Scale-up. Each customer is assigned an experienced Program Manager that will develop the plan for the customer’s approval and manage all activities and customer communication. The speed and quality of medical device outsourcing are improved because the process prevents unwarranted delays and costly mistakes.
What annual volume of product is needed for outsourcing to J-Pac Medical?
J-Pac Medical will develop and implement manufacturing processes to accommodate medical device outsourcing for products from hundreds to millions. A wide range of cleanroom formats and production methods enable us to provide a scalable and efficient contract manufacturing and packaging services across a range of volumes. Our Costa Rica cleanroom manufacturing location is also an option for larger volumes.
Packaging & Package Validation
How long does a medical device package design and validation take from start to finish?
Package Design (Phase 1): 13 Weeks
- Package System Requirements
- Sterile Barrier Design
- Protective Package Design
- Verification Testing
- Sterile Presentation Test
Sealing and Manufacturing Process Development (Phase 2 - 3): 16 Weeks
- Thermoforming & Sealing Tooling
- Thermoforming IQ/OQ
- Sealing IQ/OQ
- Device Assembly IQ/OQ
- Label Development
- Build OQ-Low for Transit Test
Transit Testing and Seal Testing (Phase 4 - 6): 13 Weeks
- Expose to Worst-Case Sterilization
- Transit Simulation
- Accelerated Aging Testing
- Real-Time Aging Testing
- Seal Testing
Sterilization Validation: 8 Weeks
These are typical lead times, but they can be significantly reduced by selecting an outsourcing partner well versed in all aspects of the process as well as having vertically integrated packaging and manufacturing processes.
Should the medical device packaging performance qualification (distribution simulation) be done at the same time as the product stability study?
No. ISO 11607-1 Section 6.4.4 indicates that stability testing and performance testing are separate entities.
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 do you validate medical device packaging?
Packaging validation is complex. There are several processes that must be completed
- 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.
- Packaging performance testing must be completed. This includes manufacturing and sterilizing under worst-case conditions and subjecting the packaging system to simulated distribution testing.
- A stability study must be completed and is typically done with both accelerated and real-time aging studies.
- Both the performance testing and stability study require tests for seal integrity and seal strength as well as an evaluation of product protection.
What medical device testing has to be done under worst-case conditions?
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.
Are microbial challenges required for medical device packaging validation?
Do I need to include an IFU (Instructions For Use) when testing?
How do I determine sample size?
Is cleaning validation required for orthopedic implants?
What tests are used for a cleaning validation?
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.
How does J-Pac perform a cleaning validation?
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
Does J-Pac perform post-thermoforming customization of medical grade trays?
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.
What is ISO 11607?
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.
What package design services does J-Pac offer?
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.
Do orthopedic implants need to be double packaged?
Shelf Life Testing
What is the determining factor in determining a medical device's shelf life?
The FDA defines medical device shelf life as, “the term or period during which a device remains suitable for its intended use.” Fitness for use can be impacted by both maintaining sterility of the medical device package and ensuring the device performs as specified after aging. A risk-based approach should be used to determine the potential impact of using a device that may no longer be fit for use. Some medical devices will experience degradation over time and the risk of that degradation to the device’s fitness for use must be assessed when determining specifications and tolerances for manufacturing and components.
A stability study must be conducted on the sterile barrier system. Packaging samples (not containing the product) typically undergo both accelerated and real-time testing to establish the shelf life of the seal. Accelerated testing is allowed for market launch but must be followed up by real-time data. Accelerated aging should follow ASTM F1980, which details the Arrhenius equation that is commonly used. This equation is based on the principle that every 10°C increase in temperature doubles the reaction rate. Both accelerated and real-time aging should be done on medical device packages that have undergone worst-case sterilization.
Stability testing can take many avenues including material strength testing as well as visual inspection and functional testing. The medical device stability tests should be conducted on a packaged product that underwent worst-case sterilization and simulated distribution.
Can the product shelf life testing be done at the same time as the stability study for the sterile barrier?
The medical device package shelf life testing and the stability study should be done separately. The FDA defines shelf life as the term or period during which a device remains suitable for its intended use. Fitness for use can be impacted by both maintaining sterility of the package and the post-aging performance characteristics of the medical device. These are two separate items and should be tested separately. The temperatures that are appropriate for sterile barrier system (SBS) materials may not be applicable to device materials. This may jeopardize the otherwise successful stability study on the SBS. When device assembly is completed and the product is packed within the SBS during stability studies, they often interfere with many of the tests that are conducted on the SBS at each aging interval. Medical devices often have a functional shelf life, which is much less than that of the SBS. These device limitations would unnecessarily shorten the dating claims for future products using the same SBS materials.
MDMs that include devices in their SBS stability studies often end up linking that particular device with the specific SBS used. They then feel it is necessary to repeat the stability study on the same SBS materials if a different device is packaged in it. This is not true. It is much better to keep SBS stability studies independent from any specific device.
Microfluidic IVD Blisters
What design services do you offer for reagent blisters?
J-Pac Medical offers a full range of design services to provide you with a turnkey solution for microfluidic reagent blisters and consumables. We work closely with you to understand the technical requirements for burst strength, activation, and other critical parameters and design a blister and manufacturing process based on those inputs. We are an FDA Registered, ISO 13485:2016 certified company with extensive expertise in blister design, material selection, and manufacturing. Other services include rapid prototyping, 3D modeling, Design of Experiments, Accelerated Shelf Life Testing, and Validation.
Can we get blister samples?
Yes. J-Pac has developed off-the-shelf samples that are an affordable and timely solution for up-front development. J-Pac offers several types of samples for purchase.
What materials do you offer?
What is the force required to actuate a blister?
The force required to activate a microfluidic reagent blister is dependent on the actuation mechanism (e.g. lance, manual compression, etc). A general guideline is 30N +/- 15N.
How do you actuate a blister?
What amount of fluid is recovered from the blister?
The amount of fluid recovered varies by the actuation and recovery method. A rule of thumb is 90% for common blister actuation methods.
What volumes can be filled?
Microfluidic reagent filling is custom to the application. A general range is between 30-1,000 ?L.
Can you perform low oxygen filling?
We have microfluidic reagent blister filling technology that can achieve both 100% fill as well as extremely low O2 levels - less than 2% on average.
What is a common fill ratio?
How do you mount the blisters?
What in-process quality control (IPQC) do you have?
Quality control is customized for each customer. Common components of our quality plan are:
- Reagent Quality: Certificate of Compliance, pH, Conductivity, Specific Gravity, and other customer directed tests.
- Fill Volume: Validated production processes, 100% weight check in certain applications, SPC controls.
- Functional Testing: We recreate the customer's activation method and test burst strength.
What is your production capacity?
J-Pac has three ranges of production capacity for lab-on-a chip reagents. Our lab can supply small volumes of less than 5,000 units. Our semi-automated production lines can produce up to 5 million units per year. Our automated lines can produce more than 30 million units per year.
Can you Manufacture Microfluidic IVD Consumables?
Yes. J-Pac can assemble complete microfluidic diagnostic consumable cartridges. Manufacturing capabilities include ultrasonic welding, laminating, heat staking, die-cutting, laser cutting, PSA application, leak testing, heat sealing, and UV bonding). We also implement automation where applicable and offer lower cost assembly options in Costa Rica.
What is your quality system?
Our quality system is an integrated system of documents, specification, procedures, and other records and systems that are compliant to FDA and ISO 13485. J-Pac uses a validated electronic quality system that automates and properly controls our quality system. Unlike many medical device contract manufacturers, we use a rigorous external auditing firm to audit our compliance to our quality system. We also undergo routine and frequent supplier audits.
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.
Does J-Pac have the ability to purchase prescription components required in a medical device package?
J-Pac Medical maintains a Board of Pharmacy Certificate, which allows us to purchase prescription drug and devices to be incorporated into customer devices.
How fast can changes be made in your quality system?
For urgent situations, changes can be implemented the same day as the request, as long as it does not impact the supply chain.
Can J-Pac sterilize our product?
J-Pac Medical offers in-house EtO sterilization that is most useful for small-lot production or high-volume production of small footprint packages. We also manage outside sterilization service companies. Our services range from organizing sterilization validations, single-lot releases, and management of on-going sterilization release and re-validation schedules.
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.
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.
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.
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.
Do you have capabilities for handling bioabsorbable implants?
Yes. J-Pac Medical is uniquely qualified to handle bioabsorbable implants. We have low humidity cleanrooms for biomaterial device assembly and packaging and offer unique formats to minimize moisture exposure during the sterilization and transportation processes.
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 biomaterial and textile providers that can provide medical grade textile materials. J-Pac Medical provides cutting, shaping, assembly, packaging, and sterilization of these materials to provide a turnkey service for its customers.
What polymers are most common in biomaterials 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 implantable biomaterials are converted at J-Pac Medical?
- 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?
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.
Biomaterials can degrade quickly. How can J-Pac help?
Absorbable biomaterials degrade when exposed to moisture and heat. This can be significant when devices undergo the total cycle from manufacturing, packaging, transport to sterilization, and exposure to sterilization humidity and elevated temperatures. J-Pac has a unique process designed to mitigate these issues. Cleanroom assembly is conducted in a special humidity-controlled cleanroom. EtO sterilization in completed in-house and with lower temperature cycles. Once sterilized, the biomaterial devices are quickly packaged, dried or gas-flushed, and sealed. A process that normally takes weeks can be done in a few days.
What assembly processes can be performed for biomedical textile implants?
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