Diagnostic Device Components
PolarSeal has been actively involved in this fast-growing market sector from the start, and now plays a key role in the development and manufacture of new diagnostic test strips.
ADHESIVE TAPE SPECIALISTS
The development of accurate in-home and over-the-counter diagnostic test products for a wide range of healthcare issues has driven intense development of multi-layer laminate construction of specialist adhesive coated films and space tape lamination.
In Vitro Diagnostic Devices
In vitro diagnostic devices (IVDs) play a crucial role in monitoring blood glucose and are widely used in the detection, prevention and monitoring of other tests such as cholesterol, rapid coagulation, infection disease, pregnancy, and other health- related factors. Other diagnostic applications include:
- Laboratory testing kits
- Diagnostics spacers
- Monitoring device Assembly
- Patient self-testing kits
Due to its multi-layered structure, there are several components required to build the IVD devices. The choice of adhesive and material is vital in the construction of the device. Hydrophilic Tape construction to consider:
- Transfer Tape
- Single Coated
- Double-Coated
Technical Info
Operating within our ISO7 Cleanroom facilities, PolarSeal can manufacture diagnostic components within controlled environments to meet your quality expectations. The intricacy of IVD devices requires accuracy, to achieve such results PolarSeal uses cutting technology under tight tolerances that are required for this sector. In-house technology and trained operators enable PolarSeal to meet high-volume demand through mass production without compromising quality.
Flexibility in Design
- Membrane-based diagnostic requirements – non-migratory inert adhesive systems for compatibility with assay-type diagnostic testing devices
- Capillary flow – various thickness materials used to facilitate volume requirements by utilising varying sized channels to regulate the amount of specimen being tested
- Hydrophilic characteristics – to customize the flow of specimen by the selection of the various coatings and adhesives available, by the control of surface tension required to reduce the test time and sample size through offering enhanced wicking
- Versatile processing capability – conformable and ease of die-cutting
- Matching the surface energy of biological fluids
- Tape construction – single coated, double-coated, or transfer film
- Diagnostic test strip
Converting Capabilities
Case Study
With the rising demand for accurate in-home and over-the-counter diagnostic test products and the tight tolerances that come with them, diagnostic testing brings challenges to medical device manufacturers. We had the challenge of designing and developing a machine that meets the tightest tolerances needed in the diagnostics market.
Problem
- There was a requirement for a highly technical and extremely tight tolerance diagnostic unit, that was a small dimension die-cut and needed lamination of hydrophilic layers and adhesive with print.
Solution
- We worked through the initial concept and put this through to design, then started with hand assembly and progressed to flat-bed die-cutting moving through the design phase. We progressed on to a basic converting line, followed by testing a full prototype production line before moving onto a full-scale converting line.
Result
- The machine developed by our Research & Development team is totally unique to the Medical Diagnostics Market and meets the tightest tolerances needed within this demanding field. The performance quality of this product is second to none and allows our client to distribute with trust and confidence, whilst also knowing end users will be able to trust the accuracy of the tests that they are conducting.
Frequently ASked Questions
What are diagnostic test strips used for?
Home or over-the-counter test strips are used to detect and monitor some diseases or health conditions. The test strips provide an important role in identifying, monitoring and controlling health conditions such as diabetes.Â
What can PolarSeal provide to the Diagnostics market?
PolarSeal combines materials to create the essential components required for the diagnostic products to the tightest tolerances needed for our clients and the consumer market.Â
What makes PolarSeal’s machinery unique?
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