At Dynascan we understand how vitally important it is for manufacturers of point-of-care testing (POCT) consumables that their packaging is free from any defects that could cause leaks such as punctures, pinholes, channel leaks in the seal area or mechanically weak seals.
If the packaging does have a defect, which could cause a leak, then it is not fit for purpose and the enclosed consumables cannot be used, meaning wasted product and resources.
In order to ensure that the packaging is free from any defects, it is necessary for manufactures of POCT consumables to test the seal integrity of their packaging and there are very strict regulations that they need to comply with.
There are a number of methods of seal integrity testing including bubble emission, burst testing and methylene blue dye leak testing, however the MediTEST, designed and manufactured by Dynascan, works on the established principle of measuring a reactive force generated by a pack when subjected to vacuum, which is by far the most superior method for manufacturers of POCT consumables.
This method is completely dry and non-destructive, meaning that it is cleaner than alternative methods and upon completion of the test, any packaging, which is deemed defect free can be reintroduced back in to the production line, significantly reducing waste and cost.
In contrast to the other seal integrity testing methods, which rely on observation and are open to subjectivity, the MediTEST provides easy-to-read results, indications and graphical test data for easy analysis and users can print and store test and meta-data, in compliance with the standard 21 CFR Part 11.
The MediTEST is extremely easy to use and no special training or tooling is required. The standard configuration consists of a front-loading tray divided into four individual compartments allowing up to four test strip packs to be tested simultaneously and with other configurations available up to ten simultaneous tests can be carried out in as little as 30 seconds.
If you would like to find out how a MediTEST seal integrity testing workstation could benefit your company, then please get in touch with one of our product specialists.
Download the MediTEST Point-of Care Workstation Technical Specification
