LIMAB UK is proud to be working with two leading diagnostic healthcare companies, who are actively involved in the development and manufacture of COVID-19 point-of-care antibody tests.
The COVID-19 point-of-care antibody tests, which are designed to deliver rapid results are microfluidic immunofluorescence assays for the direct and qualitative detection of nucleocapsid protein antigen in nasal and nasopharyngeal swab specimens from individuals suspected of COVID-19 or asymptomatic individual.
The tests cannot be used if there are any visible signs of damage to the packaging such as tears or holes, therefore it is absolutely vital that the seal integrity of the packaging is tested to ensure that it is fit for purpose.
LIMAB UK offers a range of products for the non-destructive testing of packaging seal integrity, suitable for all types of pharmaceutical packaging and have recently supplied one of the above companies with the Dynascan MediTEST and the other with the Dynascan LeakVIEW.
The Dynascan MediTEST provides advanced, non-destructive seal integrity testing, operating on the established principle of measuring the reactive force generated by a pack when subjected to vacuum. For testing filled sachets, bags, blister trays testing kits and pouches, only a few seconds are required to detect holes down to a size of 10 microns (µm). Non-destructive testing allows for flawless packaging to be reintroduced to the production line, significantly reducing waste and cost.
The Dynascan MediTEST provides easy to read results and indications and graphical test data to aid analysis. Users can store test and meta-data in compliance with 21CFR Pt 11 and output these to a printer. The modular and flexible design allows the packaging leak detection system to be optimised for each product application maximising sensitivity and minimising test time. A self-adjusting sensor system virtually eliminates the requirement for specialist tooling, with a front-loading tray enhancing the ease of use. The standard MediTEST system can test either two, four or ten pouches simultaneously, custom configurations can be provided to suit special customer applications.
The Dynascan LeakVIEW provides visual detection of leaks through either bubble emission or burst testing for a wide range of packaging. The clear Perspex test chamber is filled with water and during testing, the headspace is placed under a predetermined vacuum level causing the packing under test to inflate. Should any leaks be present a stream of bubbles will be emitted showing the location of the leak in a faulty seal. The system is able to identify holes as small as 20 microns (µm) and operates in compliance with ASTM D3078 or ASTM F2096 standards. For altitude simulation or burst testing water is not required in the test chamber. The system requires no calibration or electrical supply, is easy to use by operators with minimum training and provides dependable repeatable results.