Diagnostic components

In the realm of health monitoring, in-vitro diagnostic devices (IVD’s) hold a pivotal position, especially in the continuous surveillance of blood glucose levels. They serve as indispensable tools not only for the identification and management of conditions like cholesterol levels, rapid coagulation, infectious diseases, and pregnancy but also for monitoring various other health-related factors. Additionally, other key diagnostic applications include:

• Laboratory testing kits
• Diagnostics spacers
• Monitoring device assembly
• Patient self-testing kits

Owing to its intricate multi-layered architecture, the assembly of IVD devices necessitates the incorporation of several essential components. The selection of appropriate adhesives and materials is of paramount importance in the fabrication process. Key elements to contemplate in the construction of the device include hydrophilic tape architecture.

• Transfer tape
• Single coated
• Double-coated

Functioning within the confines of our ISO7 Cleanroom facilities, PolarSeal has the capacity to produce diagnostic components in meticulously controlled environments, ensuring adherence to your exacting quality standards. The intricate nature of IVD devices demands precision, and to achieve such standards, PolarSeal leverages cutting-edge technology under stringent tolerances specific to this sector. With our in-house technological capabilities and skilled operators, we are well-equipped to meet the demands of high-volume production, ensuring mass manufacturing without any compromise on quality.

PolarSeal boasts complete expertise in this sophisticated technical domain, providing exceptional flexibility in terms of the available options concerning the design and production specifications of these specialized products. These offerings may encompass:

• Non-migratory inert adhesive systems suitable for assay-type diagnostic testing devices.
• Capillary flow facilitated by materials of varying thickness, regulating specimen volume through channels of different sizes.
• Tailored hydrophilic characteristics, achieved through a selection of coatings and adhesives, to customize specimen flow, control surface tension, reduce test time, and optimize sample size via enhanced wicking.
• Versatile processing capability, offering conformity and ease of die-cutting.
• Surface energy alignment with biological fluids.
• Tape construction options, including single-coated, double-coated, or transfer film, to cater to diverse application needs.
• Development of diagnostic test strips.