Manufacturers of personal protective equipment (PPE) and protective rubber clothing can now quickly gain CE stamp of approval through the use of Ellutia automated Permeation analysis system. The automated systems speeds up analysis time through new simultaneous testing methods, to determine the rubber glove material resistance to chemical permeation specified under European Regulation EN 16523-1.[1] Test results can be reported as specified by ISO to qualify for the appropriate CE mark for essential protective clothing.
Any hospital, laboratory or manufacturing environment requiring its employees to work with hazardous materials or in a potentially hazardous environment, including across healthcare, industrial chemicals, manufacturing, cleanroom and defence, must provide protective clothing in compliance with PPE Regulation (EU) 2016/425. For use in Europe, all Category II and III PPE suits, gloves and footwear must carry the CE mark of approval that categorises each product’s resistance to the specific chemical being handled.
Because permeation – the process by which a chemical passes through a material at molecular level – can occur undetected, with no visible damage to the rubber, it is essential to test for each specific chemical before accreditation can be given. Six performance levels are assessed against 18 different test chemicals in accordance with ‘breakthrough time’, i.e. the time from the start of the test to the time a chemical is detected on the other side of the material, at a defined rate of 1µg per cm2 per minute.
In tests, the rubber glove material is stretched over the series of cells and the challenge chemical introduced. The rubber material’s resistance to the challenge chemical is tested by measuring any rise in contamination levels in the initially clean headspace. The breakthrough time is plotted and recorded using custom software to report on the level of the rubber’s resistance.
Optional automated challenge chemical introduction means cells can test a series of different challenge chemicals, or each hold the same chemical, for multiple automated testing. In addition, the system offers the flexibility to vary the test speed depending on a sample’s breakthrough time, which can range substantially from one minute to up to eight hours. This removes the need to wait for longer tests to finish before obtaining completed test results.
This level of automation dramatically speeds up time to result, as the challenge chemical can be automatically introduced to all required cells in rapid rotation, with no need to wait for the test on cell one to finish before moving to cell two.
Andrew James, marketing director at Ellutia said: “Moving towards a greater degree of automation dramatically increases throughput. At a time when the world’s hospitals and healthcare organisations desperately need PPE, this degree of automation in quality testing can help speed up the manufacturing process through running multiple cells simultaneously, 24 hours a day.”
