“Cost” is an awfully big word for being only four letters. And as developers of point-of-care diagnostic reagent blisters know well, the costs to bring reagent blister products to market have many different sources. Some are easier to spot than others. Some stay hidden until it’s too late, putting years of work (and lots of […]
The mechanical forces specified to access reagents packaged in on-board microfluidic blisters used in point-of-care diagnostic products is essential to their clinical use. But designers of these products must consider how these activation forces relate to risks inherent to the blister manufacturing process that could manifest in later clinical use. Identifying the ideal blister pack […]
The most obvious marker of a reagent blister product’s success is whether the test it helps perform provides fast, accurate results that guide patient care. But clinical factors are only a small share of what ultimately determines the viability of reagent blister products. Developers might be less familiar with the design and manufacturing considerations that […]
The FDA recently held a panel meeting regarding Eto Sterilization. Topics included replacement sterilization methods, reduction in EtO usage, impact of shortages, and reduced SAL requirements. J-Pac is currently adding in-house EtO capacity to help our customers, especially early stage customers, cope with the capacity reduction experienced in the industry. Learn more at https://lnkd.in/fVri6ja
Provides a validated QMS solution to accommodate increased regulatory requirements Somersworth, NH (October 11, 2019) – J-Pac Medical, a leading medical device outsourcing partner announced that it has adopted an electronic Quality Management System that seamlessly integrates all of its quality and regulatory compliance processes. The suite of validated, FDA/ISO compliant electronic business processes is […]
Additional Cleanroom Capacity is Due to Market Demand and Growth J-Pac Medical, a leading manufacturing and packaging outsourcing partner to medical companies, has opened a new manufacturing facility in Cartago, Costa Rica. The new facility houses a Class 8 cleanroom and adds capacity for J-Pac to manufacture and package medical devices that require stringent environmental […]
J-Pac can help get your diagnostic test to market quicker and at a decreased cost through the use of Diagnostic Reagent Sample Kits.
J-Pac now has the technology to manufacture diagnostic reagent blisters with 100% fill volumes that contain no air.
Using frangible seals, POC platforms can provide accurate test results and help to eliminate the multistep lab process in which human error and instrument contamination are most likely to occur.
Frangible seal blisters provide a simple, elegant, and cost-effective way to rapidly upgrade existing POC test platforms or to roll out new test offerings.