COVER STORY
contamination. The material used to make a wipe can make a significant difference to the efficacy. Some materials will absorb and not release certain parts of a solution meaning that a solution might have efficacy against certain organisms but when it is released from a wipe, it can no longer provide that efficacy.
Testing the efficacy of wipes
In 2015, Dr Jürgen Gebel of the University Hospital in Bonn, Germany, and his team published the EN16615:2015, which is now the only accepted and referenced EN standard for testing the efficacy of disinfectant wipes. The objective of the EN 16615 is to test the actual wipes efficacy rather than the extracted solution used in the wipe as per previous test methods. This gives a better representation of the wipes in use by using a mechanical wiping motion with a constant measured pressure on the surface. It ensures there is no cross contamination caused by the wipes and confirms the compatibility between the active ingredients in the solution and the wipe material. The steps below (also illustrated) describe Dr Jürgen Gebel’s method for EN16615 tests. 1. A vinyl test area is prepared, replicating the surface to be disinfected. This area is marked with four 5x5cm squares (25cm2
EN16615 is known as the ‘4 field’ test because of the four test fields.
2. The first field is inoculated with a measured amount of the microorganism to be tested. EN16615 has been developed to test for efficacy against bacteria and yeasts.
3. The microorganisms are dispersed evenly over the first test field and the surface is left to dry. The remaining three test fields are left ‘clean’.
4. To simulate the physical downward force of a person wiping a surface, a block weighing 2.5kg is placed on top of the test wipe.
5. The block is pushed from the side in a smooth, two second, motion across the whole test area. The wipe is carried first over the inoculated field, then over the clean fields two to four.
6. This wiping motion is then reversed, with the block and wipe pushed back over all four fields in another smooth two second motion. By passing the wipe back over clean fields, the test shows if cross contamination is occurring.
7. After the requested contact time, all four fields are swab tested to measure the presence and level of the test microorganism.
Passing the test requires a five log reduction in bacteria or four log for yeast in test field one and less than 50 colony forming units (cfu) of organisms in fields two to four. Pal International, the Midlands-based innovator of infection prevention products and owner of the Medipal brand, has been actively campaigning to raise awareness of
SEPTEMBER 2017 Testing method for wipes
).
Contact Medipal on:
uksales@palinternational.com Tel: +44 (0) 1455 555 700 Pal International Ltd. Bilton Way, Lutterworth Leicestershire LE17 4JA United Kingdom
the first real-world, European test for chemical disinfectant wipes. Manufacturing and operating under strict quality management systems such as BSI ISO9001:2008, ISO13485 (CE Marking for Medical Devices), ISO14001 (Environment), BRC and GMP and Halal, Pal International works with active substance suppliers from the Article 95 list of approved suppliers, accredited testing laboratories and established non-woven materials manufacturers to produce disinfectant wipes that are truly compliant at all levels. Responding to healthcare market demand for a robust single-use product, the company has applied its technical expertise, as well as an understanding of the strict regulations surrounding the use of disinfectant chemicals in their wipes to create the new Medipal 3in1 Disinfectant Wipes. This product range
can be used for cleaning and disinfecting as well as offering sporicidal efficacy whilst remaining alcohol and PHMB free. Medipal 3in1 disinfectant wipes continue to be compliant with the latest regulatory requirements governing harmonised product safety, efficacy and consumer communication across Europe. Medipal is at the forefront of regulatory developments such as EU exit matters concerning the Biocidal Products Regulation, implementation of the Medical Device Regulation in 2017 and new efficacy test standards. Whilst efficacy tests are constantly being reviewed and developed such as the new prEN 16777 in draft form for chemical disinfectants, it is likely in the future, that more bespoke tests incorporating mechanical action (wiping), and those incorporating any emerging resistant microorganisms will prevail.
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