Point of Care Reagent Blisters FAQs

Design

What design services do you offer for reagent blisters?

Multiple Liquid Blisters

Multiple Liquid Blisters

Various formats of liquid blisters including clear lidding. Mutiple die cut bases available.

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?

Multi Blister Array

Multi Blister Array

Cold-formed foil blisters used for onboard reagent storage. Multiple blister shapes and volumes can be included on the same array.

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.

Blister Activation

What is the force required to actuate a blister?

Diagnostic Point of Care Consumable

Diagnostic Point of Care Consumable

Molecular diagnostic test card with reagent blisters mounted. One microfluidic card contains five custom sized blisters, including mineral oil, buffer, and lysis.

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?

Various sized reagent blisters

Various sized reagent blisters

Reagent blisters from 25 to 150 microliters.

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

Filling

What amount of fluid is recovered from the blister?

Clear Blister

Clear Blister

Liquid filled blister with clear reservoir and foil lid. Custom sealing pattern controls activation strength. Clear lids also enable laser welding.

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?

Clear Blister

Clear Blister

Liquid filled blister with clear reservoir and foil lid. Custom sealing pattern controls activation strength. Clear lids also enable laser welding.

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?

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).

Mounting

How do you mount the blisters?

Diagnostic Point of Care Consumable

Diagnostic Point of Care Consumable

Molecular diagnostic test card with reagent blisters mounted. One microfluidic card contains five custom sized blisters, including mineral oil, buffer, and lysis.

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

Production

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?

Precision Slitting

Precision Slitting

A roller slitter precision cuts plastic sheeting for further packaging operations.

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.

Latest News

June 24, 2020


Wall Street Journal - What We Know About Face Shields and Coronavirus

The Wall Street Journal discusses how medical face shields can be an effective part of protection against COVID transmission in many non-medical environments such as schools.

Call Our Engineers Now

603.692.9955

info@j-pacmedical.com