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.

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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.

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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
PolarSeal understands the importance of reliable adhesives and the role they play in IVD device construction.
Medical Adhesives
testing

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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.

Flat bed medical die cutting graphic
glucose test strip

Flexibility in Design

PolarSeal is fully qualified in this advanced technical field and can offer great flexibility in terms of the options possible in respect of the design and production specifications of these specialist products which may include:
  • 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

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Material slitting visual graphic
Slitting
Polarseal lamination graphic
Lamination
Flat bed medical die cutting graphic
Cutting
Packing line graphic
Packing
Guillotining for laminating sheeting graphic
GUILLOTINING
tube filling polarseal
Tube Filling
Flexographic printing graphic
Printing

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

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. 

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. 

PolarSeal’s bespoke machines and processes were developed by our Research & Development team, which meets the tightest tolerances needed within the demanding diagnostics market, providing accurate testing.

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Send us an email to discuss your project requirements in more detail using the contact form below or book a 1-on-1 video call with a member of the team on a day and time that suits you best using the calendar booking system below.

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