Diagnostic Consumables

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Molecular diagnostic consumable with reagent blisters

Diagnostic Reagent Sample Kits

As diagnostic tests move closer to the point-of-care, reagent storage and delivery methods become a challenge. J-Pac Medical’s lab-on-chip reagent blisters allow reagents to be stored directly on the microfluidic cartridge, enabling the smaller footprint required by point-of-care diagnostic tests.

Contact customer service at 1-603-692-9955 to order sample kits. Credit cards are accepted.

Sample Blister Fluid Volume
Dim. (Inches) 30μl 130μl 250μl 500μl 750μl 1,000μl
Height 0.108 0.175 0.190 0.26 0.245 0.268
Diameter 0.394 0.585 0.765 0.875 1.006 0.988
Flange 0.065 0.118 0.133 0.096 0.125 0.118
Pierce Dia. 0.264 0.375 0.500 0.625 0.750 0.752

About J-Pac Medical

J-Pac Medical is the trusted manufacturing and packaging outsourcing partner to medical device companies seeking to deliver superior quality, improve time-to market, and simplify the supply chain for single-use medical devices.

blister diagram

Point-of-Care Diagnostic Blisters Product Sheet

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Multiple dome shaped piercable reagent blisters

A Pioneer in Point-of-Care Reagent Technology

The continued growth of point-of-care diagnostic tests offers improved patient outcomes as well as lower overall costs. A key to the success of these lab-on-chip applications is enabling reagents to be stored and dispensed on microfluidic test cards.

J-Pac has leveraged its expertise in polymer manipulation to become the leading manufacturer of reagent blister reservoirs used in lab-on-chip tests. Our technology allows reagents of multiple chemistries and volumes to be safely and effectively stored on the test card until it is required by the test.

One-Stop Solution

Our unique approach offers a one-stop solution for both blister development and manufacturing. We have a deep technical understanding of blister technology for microfluidic applications and can design blisters for custom activation mechanisms. We produce blisters to support the product life cycle from samples and pilot runs, to initial launch and high volume production.

J-Pac offers both sample packs and development kits to help our customers that are in the early stage of development and seek to get acquainted with our technology. Sample packs include a small number of burst and frangible seal blisters while development kits come in larger volumes, specific shapes, and can include custom reagents. Additionally, J-Pac offers “No Head Space” technology to enable low-oxygen reagent storage.

Case Study: Point-of-Care Diagnostic Blisters

The Challenge

A Diagnostic Device Company approached J-Pac Medical to develop reagent blisters that would accommodate single test quantities of reagent to be mounted onboard Point-of-Care Test Cards.

The company needed support to identify appropriate materials, methods and procedures to provide reagent filled foil blisters that could be shipped safely in bulk, yet dispense the reagent in a controlled way when coupled to the test card and ultimately activated during the performed diagnostic test.

Our Solution

J-Pac Medical identified and procured all equipment needed, fabricated all tooling, and developed & validated all processes associated with the filling, forming and sealing of these reagent blisters.

The Results

The company became first to market for a point-of-care diagnostic product utilizing reagents on a disposable test cartridge.

Molecular diagnostic consumable with reagent blisters

Allograft Processing Bags

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allograft textile pouch

Features

  • Medical grade materials – ISO 10993 biocompatibility
  • Polypropylene and Polyester
  • Off the shelf materials
    • Pore sizes ranging from .05mm to 4.0mm
    • Multiple mesh weight and knit formats available
    • ETO or steam Autoclave sterilization compatible
  • Customizable based on customer needs
    • Pore size of mesh
    • Size of bags
  • Particulate-free edges
  • Packaged individually or bulk
  • Pre-package washing option
  • Shipped sterilized

Applications

  • Demineralize Bone Matrix
  • In-Process Tissue Handling
  • Packaging
Medical mesh sheets

Specifications

Allograft Processing Materials
PHYSICAL CHARACTERISTICS
Material Polypropylene Polyester
Construction Knit Weave
Applications Demineralization
Tissue Carriers
In-line Filtration
Centrifuge Liners
Demineralization
Tissue Carriers
In-line Filtration
Centrifuge Liners
Pore Sizes (mm) .8 – 4.0 .0050 – 3.0
Dimensional Integrity Compliant Stable
Sterilization Tolerance Eto
Steam
Demineralization
Steam
Gamma
E-Beam
BIOCOMPATIBILITY PROFILE
Hemolysis Pass Pass
Cytotoxicity Pass Pass
Intracutaneous Toxicity Pass Pass
LAL Pass Pass

Biomedical Textiles Devices

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overlapping textiles on surface

Biomedical Textile Devices

J-Pac is a leading manufacturer of biomedical textile devices, many of which must adhere to stringent anatomical geometries. We manufacture implantable-class textile based devices in four Class 7 clean rooms which contain customized equipment allowing 3D shaping without altering the base geometry and strength of the textile material.

Our textile products are often combined with other sterile devices in custom, ready-to-use sterile procedure kits that are designed and manufactured in-house on our thermoforming equipment. All our manufacturing processes are validated. Our capabilities also include custom fabricated mesh bags and filters for tissue bank allograft processing. These mesh bags and filters are manufactured and sterilized to the highest quality standards to improve cleanliness and adhere to FDA guidelines.

Our Unique Capabilities

J-Pac has developed unique manufacturing processes that allow customers to achieve anatomically correct shaped textiles with particulate-free, smooth edges that prevent irritation of the surrounding tissue.

Our processes include 3D forming, welding, sewing, and bonding an array of textile materials without altering the base properties of the raw material. In fact, we are able to increase the strength of the material at the joints and increase stability in many cases.

  • Anatomically correct formed textiles
  • Particulate free
  • Smooth edges to prevent tissue irritation
  • Processing to prevent suture pull-out
  • Bio-absorbable processing

Case Study: Implant Textiles

The Challenge

A Medical Device company with a broad presence in the soft tissue repair surgical segment came to J-Pac with a challenge to manufacture a 3-Dimensional shaped, multi-component textile implant.

The company had prototyped the product, but had failed to find a suitable manufacturer after a global search.

Our Solution

J-Pac Medical provided the tooling, equipment and validated processes to pressure form and assemble the textile implant, as well as provide it with a custom edge treatment designed to enhance tissue passage and reduce particulate.

The implant was provided to the customer in a tray/lid primary package put-up, also manufactured by J-Pac Medical.

The Results

The company achieved first to market status with an innovative design that became the leading mesh technology in the market.

Heat formed biomedical textile implant

Turnkey Sterile Medical Device Packaging Solutions

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medical device packaging

Turnkey Sterile Medical Device Packaging and Sterilization Solutions

Our turnkey packaging services are ideal for sterile surgical and procedure kits where multiple components are packed together and lot control and traceability are of the highest importance. Our packaging processes are validated and we have a long track record of exceptional on-time delivery. We specialize in medical device contract manufacturing of both small and medium volume products.

We offer a full range of medical device outsourcing solutions includingmedical device package design and validation, managing sterilization from protocol development, publishing final test results, and managing the ongoing sterilization process, including laboratory testing. We offer in-house medical device EtO sterilization as well as “single release” where no validation is required.

In-House Thermoforming

We provide better quality medical device contract packaging services because we control the thermoforming process of the packaging trays. We pride ourselves on our unparalleled ability to work with heavy gauge and other difficult materials such as polycarbonate. Our thermoformed packaging capabilities include post-forming fabrication to manufacturing thermoformed packaging with vents, handles, locking tabs, and welded internal components. We also provide customized trays to support specialized lyophilization processes.

Broad Array of Formats

J-Pac Medical performs cleanroom assembly and packaging sterile devices in eleven class 7 and 8 clean rooms. Formats include Form Fill SealTray/LidBags, and Foil Pouches. We also specialize in gas flushing and dry room packaging.

Case Study: Packaging Design Optimization

The Challenge

A Cardiovascular Device Company came to J-Pac Medical with a request to establish a contract packaging capability in the United States. The existing packaging flow had been established in Europe, as was the package design.

Our Solution

As part of the overall transfer, J-Pac proposed a total redesign of this existing package to reduce the overall footprint, as well as downgauge all packaging materials.

The Results

In addition to reducing the overall footprint and down-gauging packaging materials, our redesigned package also enabled a 40% increase in Eto Sterilization throughput. Freight gains were also realized.

Before/After

medical device packaging