Frequently asked questions

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.

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.

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.

No, J-Pac Medical has no products of its own. Medical devices containing biomaterials are built to our customer’s specifications and the design history file (DHF) resides with our customer.

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.

J-Pac Medical primarily works with Braids, Weaves, Knits, and Non-woven Structures.

• 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.

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.

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.

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.

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.

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.

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.

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.

Blisters are typically mounted using a pressure sensitive tape that is custom fit to the microfluidic cartridge.

A lab-on-a-chip reagent blister fill ratio of 80% full is common, resulting in a headspace ratio of 20%. J-Pac can also provide microfluidic reagent blisters with 100% fill (i.e. zero head space).

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.

Microfluidic reagent filling is custom to the application. A general range is between 30-1,000 ?L.

The amount of fluid recovered varies by the actuation and recovery method. A rule of thumb is 90% for common blister actuation methods.

We have experience in many actuation methods. Common approaches include lancing, mechanical compression, and rolling.

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.

We select materials based on the specific needs for reagent chemistry. For most applications, a multi-layered foil material is used that consists of a lidding foil and forming foil.

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.

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.

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.

J-Pac offers a turnkey ISO/FDA compliant medical device package design and validation process that can be integrated into your technical files.

1. We start with documenting customer requirements for their medical device package, which includes usability issues and aseptic transfer requirements, as well as labeling preferences.
2. 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.
3. 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.
4. 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.
5. 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.
6. 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.

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.

ISO 11607

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:

1. Process FMEA to determine possible sources of contaminants, including suppliers that touch the device
2. Benchmarking non-cleaned parts
3. Establishing acceptance criteria
4. Grouping of samples by material type/family, cleaning process
5. Identification of worst-case conditions to test
6. Establishing a statistically rationale sample size
7. Establishing the cleaning process steps and parameters
8. Post cleaning testing
9. Establishing Alert and Action Levels
10. Establishing post validation sampling plan and change control plan

Typically, testing covers three areas:

1. Cytotoxicity: a test for overall safety, measuring if the device material or residuals are cytotoxic.
2. Bacterial Endotoxin: a test of harmful endotoxin contamination, which is typically introduced by water and can be very dangerous to patients.
3. Bioburden: a test of fungal or bacterial contamination.

If the orthopedic implant is cleaned prior to packaging, the cleaning process must be validated to ensure a high probability that the cleaning specifications are met (FDA CGMP). There have been numerous recalls in orthopedics caused by cleaning processed getting out of control, which left patient harming contaminants on the product. A cleaning validation should be evaluated starting with a product and process FMEA that shows possible sources of contamination and their impact and severity.

There is no single standard for sample size selection. When determining the right sample size for your product, the most important factor to consider is risk. ISO 11607-1 section 4.3 indicates that sample sizes must be based on some statistical rationale and references sampling plans in ISO 2859-1 and ISO 186.

The IFU is required for the package performance test because it may impact the integrity or strength of the sterile barrier during shipping and handling. For example, an IFU with sharp edges may cause tears.

There is no universally accepted method of demonstrating microbial barrier properties, although there are efforts to address this that may eventually be incorporated into the standard. The part 1 standard section 5.2.2 indicates only that the microbial barrier requirement can be demonstrated by showing the material is impermeable. Annex C requires that impermeable materials for sterile barrier systems shall be tested for air permeance in accordance with ISO 5636-5. Other tests are noted in Annex B. In practice, demonstrating a sufficient microbial barrier is performed on the material itself by the raw material supplier and their test reports can be referenced in the MDM’s technical file.

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.

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.

Package Design (Phase 1): 13 Weeks

• Package System Requirements
• Sterile Barrier Design
• Protective Package Design
• Prototyping
• 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 Integrity Test
  • Seal Strength Test
  • Product Stability Test
• Seal Testing
  • Accelerated Aging
  • Real-Time Aging
  • Seal Integrity Test
  • Seal Strength Test

Sterilization Validation: 8 Weeks

• Manufacturing PQ
• Single Lot Verification 1
• Single Lot Verification 2/3 (Additional 16 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.

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.

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.

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.

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.

Yes. We are certified through BSI to ISO 13485:2016. Our certification number FM 66316.

Yes. Our FDA registration number is 1221051.

Yes. In fact, the WIP exposure of these products is minimized with the sterilization occurring under one roof with assembly and packaging as compared to a production flow requiring shipping of product to and from an off-site sterilizer.  Degradation of the resorbable polymer is minimized with J-Pac Medical’s integrated assembly, packaging and sterilization flow.

While it is true that capacity is severely challenged, J-Pac Medical has available Eto Capacity in its GS8X Sterilizer, and has the ability and space to add chambers as needed to meet customer needs.

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.

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.

For urgent situations, changes can be implemented the same day as the request, as long as it does not impact the supply chain.

For urgent situations, changes can be implemented the same day as the request, as long as it does not impact the supply chain.

J-Pac Medical maintains a Board of Pharmacy Certificate, which allows us to purchase prescription drug and devices to be incorporated into customer devices.

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.

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.

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.

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.

Yes. In fact, the WIP exposure of these products is minimized with the sterilization occurring under one roof with assembly and packaging as compared to a production flow requiring shipping of product to and from an off-site sterilizer.  Degradation of the resorbable polymer is minimized with J-Pac Medical’s integrated assembly, packaging and sterilization flow.

While it is true that capacity is severely challenged, J-Pac Medical has available Eto Capacity in its GS8X Sterilizer, and has the ability and space to add chambers as needed to meet customer needs.

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.

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.