FAQs

Company

How experienced are you in the medical device industry?

J-Pac Medical has been in business since the late 1970s. We focus exclusively on medical and diagnostics.

How large is J-Pac?

We operate in a 60,000 s.f. freestanding manufacturing building, which houses 11 cleanrooms. We ship globally. J-Pac has additional cleanroom manufacturing in Costa Rica.

How do you support your customers?

We have an Innovation Services group that is dedicated to helping customers through all phases of the process, from determining requirements through transfer to manufacturing. You will be assigned an engineer to assist you. Once your program is in production, you will be serviced by our customer service team.

Do you work with small companies?

Yes. We work with both large and small companies, including start-up companies that are funded.

Point of Care Reagent Blisters

Design

What design services do you offer for reagent blisters?

J-Pac offers a full range of design services to provide you with a turnkey solution. 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.

What materials do you offer?

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

Blister Activation

What is the force required to actuate a blister?

The force required is greatly dependent on the actuation mechanism (e.g. lance, manual compression, etc). A general guideline is 30N +/- 15N.

How do you actuate a blister?

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

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 methods.

Filling

What volumes can be filled?

Filling is custom to the application. A general range is between 30-1,000 μL.

Can you perform low oxygen filling?

We have proprietary filling technology that can achieve both 100% fill as well as extremely low O2 levels.

What is a common fill ratio?

A fill ratio of 80% full is common, resulting in a headspace ratio of 20%.

Mounting

How do you mount the blisters?

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

Production

What is your production capacity?

J-Pac has three ranges of production capacity. 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 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.

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.

Quality

Cleanrooms

Does J-Pac Medical have cleanroom capabilities?

We utilize eleven class 7 and class 8 cleanrooms by customer to maintain confidentiality and control. We also have a dry cleanroom where we can control temperature and humidity for sensitive products.

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.

Controlled Substances

Does J-Pac have the ability to purchase prescription components?

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

Change Implementation

How fast can changes be made in your system?

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

Sterilization

Can J-Pac sterilize our product?

J-Pac does not sterilize product onsite but we do have several sterilization houses on our approved supplier list and will work with you to determine which one best suits your needs.

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.

Regulatory

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.

Label Control

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.

Manufacturing

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.

Call Now

603.692.9955

info@j-pacmedical.com