Diagnostic Reagent Blisters Services
Our reagent blister development kits and frangible seal blister technology help to bring new and improved diagnostic products to market quickly and affordably.
Our diagnostic reagent blister development kits allow customers to test the use of lab-on-chip reagent blisters with their microfluidic formats for diagnostic applications. Point-of-Care Testing (POCT) platforms utilizing these blisters help eliminate multistep lab processes where human error and instrument contamination are most likely to occur.
J-Pac’s reagent delivery technologies are available in burst and frangible seal blister formats. Burst blisters are used in applications where the test equipment pierces and evacuates the fluid. Frangible seal blister technology is used to deliver controlled release of reagents using J-Pac’s differential seal technology.
Point-of-Care Testing (POCT) platforms utilizing J-Pac Medical seals provide improved patient outcomes with accurate test results that both the patient and clinician can trust, while eliminating the multi-step lab processes where human error and instrument contamination are most likely to occur.
J-Pac Medical designs and constructs the right lab-on-chip reagent blister for each specific microfluidic application. Designs are prototyped in our blister lab that uses the same equipment used for production. Our processes are designed for modularization allowing us to create and build our own tooling quickly. Sample kits are provided to assist customers in the up front evaluation of blister design.
Designs are a function of requirements for geometry, actuation method, and seal strength requirements.
Testing + Validation
Testing is conducted in-house and includes checking fill volume, seal strength, and dimensional stability. Validations are conducted for filling and sealing. We also conduct in-house accelerated aging studies to determine how seal strength may be impacted by time. This serves as a basis for shelf life claims. In most cases, we incorporate the customers’ blister activation technique into our own testing.
Our forming, filling, and sealing processes are developed based on the customer’s requirements for the product. Process parameters are developed using a design of experiments (DOE) approach to optimize the parameters to meet the specifications.
J-Pac Medical has three production platforms: manual, semi-automated, and automated. The appropriate process is selected based on the customer’s commercialization needs.
All of our processes use the same technologies for forming, filling, and sealing to maintain consistency during scale-up. Our production methods can handle small and large volumes - up to 40 million units per year.
Supply Chain Management
We have strong working relationships with the suppliers that are critical to diagnostics reagent blisters including foils, lidding, and custom reagents. We partner with an ISO certified reagent manufacturer that ensures molecular reagent quality and compliance to formulation. Lot release chemical test results can be provided including pH, conductivity, and specific gravity.
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J-Pac is ready to simplify your supply chain by manufacturing and packaging your single-use medical devices.