Statement by Dr. Maximilian Weiß, CEO of Palas GmbH, on the extended mandatory mask requirement adopted as of yesterday.
"The mandatory wearing of FFP2 masks generally increases protection against corona. But not all masks protect as well as they should. According to the DIN EN149 standard, FFP2 masks are only allowed to have a penetration of 6 percent of airborne particles. However, of the more than 400 masks we tested in the last three months, 80 percent failed to meet this requirement for the smallest aerosol particles. In some cases, approved and CE-marked FFP2 masks showed a penetration of more than 30 percent in the range of virus particles. Therefore “beware of carelessness” with FFP2 masks."
In addition to masks of insufficient quality and in some cases counterfeit masks, the standard itself, which is used to test respirators at specified testing institutes, is also problematic. FFP2 masks are actually designed for coarser dust particles, not the smallest aerosols, and it is these larger particles that are tested for. Thus, the results from testing institutes do not reflect the degree of penetration of the smallest aerosols and incorrectly evaluate FFP2 masks in terms of protection against the smallest aerosol particles, such as corona viruses. This problem has been insufficiently addressed by consumer protection agencies, although FFP2 masks could be evaluated correctly and realistically using modern measurement methods.
The measuring devices from Palas can evaluate the quality of filters and protective masks even in the size range of virus particles. To better protect doctors, nursing staff and patients, Palas has been offering hospitals testing of the protective masks used there since December 2020: testing of FFP2 masks on the world's most advanced mask testing systems.
For more information on mask testing, visit: palas-counts.com/masktesting/.
Three simple tips for ensuring safer protection with FFP2 masks
1. When selecting protective masks, favor manufacturers who take quality control very seriously. Check with your supplier about their quality assurance.
2. Look for a complete and correct CE label on the FFP2 mask. Although a test according to the current standard does not reflect the degree of penetration in the range of virus particles, the CE marking is currently the only indication of quality.
3. To verify that the labeling is not a fake, you can enter the CE number on the website of the EU Commission and have the test confirmed by the mentioned test institute.
The fact that many of the protective masks in circulation do not sufficiently protect against the small corona virus has been frequently reported and proven in the media in recent weeks. Therefore Palas GmbH offers to test and qualitatively evaluate mask types with the high-precision protective mask tester PMFT 1000 M. Operators of pharmacies, clinics and care facilities, but also large companies or other institutions, which need many masks for their employees and customers, can have their masks in use tested quickly and easily by this quality test.
The Palas GmbH has tested and evaluated masks in the last weeks as an expert for aerosol technology for different TV stations and editorial offices (selection see below). Since the beginning of the year the company already offers measurements for quality assurance and product improvement as service for manufacturers, importers or dealers of protective masks. Since then Palas has tested more than a thousand masks.
All measurements resulted in a uniform picture: Numerous masks - whether FFP-2 or FFP-3 - are qualitatively insufficient and there are isolated masks with extremely poor quality. This is a frightening result, because the end customers use the masks with the expectation to protect themselves and others - possibly risk patients.
"Unfortunately, we cannot and must not disclose our previous results for data protection reasons. Some tests for television were also carried out anonymously. But we would like to offer our help in the current situation. We have the necessary expertise and above all the equipment to test the purchased masks precisely so that the end customer can be sure that his mask keeps what it promises", explains Dr. Weiß, CEO of Palas GmbH.
A further problem besides the insufficiently produced and partly fake CE-marked masks is the standard itself, with which the masks are tested in certified test institutes. Thus FFP2 masks are actually designed for coarser dust particles and not for smallest aerosols. Small virus particles penetrate the masks much more easily, with a penetration of far more than 6%.
In order to make the quality of the masks recognizable to end customers, the Karlsruhe-based company is also introducing a quality label. This shows immediately and clearly how safe the masks are - in line with the energy efficiency label.
Further information about Palas GmbH (only in German):
- TV contribution ZDF WISO (26.10.2020): https://www.zdf.de/verbraucher/wiso/minderwertige-ffp2-masken-auf-dem-markt-100.html
- Statement on the ZDF WISO contribution by Dr. Maximilian Weiß
- TV contribution SWR: https://www.swr.de/swraktuell/baden-wuerttemberg/karlsruhe/schutzmasken-aus-pforzheim-102.html
- TV contribution ARD morning magazine: https://www.ardmediathek.de/ard/video/Y3JpZDovL2Rhc2Vyc3RlLmRlL21vcmdlbm1hZ2F6aW4vNDg3ZDJjNWEtNjZkMC00YTkxLTk3N2UtYzdkMWQ0NjE4MGI3/
In the last months Palas® has made a name for itself especially with solutions for the containment of the corona pandemic. Already in July 2020, the company, together with the independent testing service provider TÜV NORD and BASF, developed a new mask test laboratory on the BASF Innovation Campus in Shanghai, in which Palas® testing agents are used. The initiative thus supports the Federal Ministry of Health in the procurement of masks from China for medical and non-medical purposes. The PMFT 1000 is also in use here.
In addition, the company has developed two further devices this year, which can also contribute to the containment of the corona pandemic. The Infection Risk Monitor measuring system measures the smallest airborne particles, including virus-laden aerosol particles, and, if the concentration is too high, informs the people in the room of this danger. The special feature of this device is that it measures not only the virus-laden aerosol droplets but also the CO2 concentration in the air.
And in September this year Palas® presented its new exhalation device, the Resp-Aer-Meter . This allows the measurement of particle size and number in the air breathed and the identification of possible superemitters.
And a Stuttgart airline is already using the device for its passengers and for employees at the entrance and security control.
The Palas GmbH, located in Karlsruhe, has more than 35 years of experience in the generation and measurement of aerosols as well as in the testing of filters. We performed the test for WISO with our high-precision protective mask tester PMFT 1000 M . The German Federal Government reacted already in spring and bought some of these test benches and shipped them to China in order to be able to check the quality of masks on site before they are exported to Germany.
Since the beginning of this year we also offer manufacturers, importers or dealers of protective masks to carry out measurements for quality assurance and product improvement in our company . Numerous test institutes, authorities and manufacturers of masks have already purchased our test systems.
As far as the results of the tests for the WISO editorial office are concerned, we are unfortunately unable to provide information about the manufacturer and origin of the masks. We have received these from the editorial department in anonymized form and are not allowed to give any further information to the outside world for reasons of data protection.
However, as mentioned in the article, there are some things you should consider when buying FFP2 masks. Therefore we would like to urgently advise you:
- Prefer the purchase of protective masks from German manufacturers. They take quality assurance very seriously and deliver good quality.
- Make sure that an FFP2 mask is fully and correctly CE-marked.
- To check that the marking is not a fake, you can enter the CE number on this page of the EU Commission and have the test confirmed by the testing institute mentioned above.
Since offering mask tests as a service, we have performed well over a thousand measurements. Unfortunately, our test results are the same as those for the WISO editorial office. Many FFP2 masks are qualitatively insufficient and there are isolated masks with extremely poor quality.
An additional problem of FFP2 masks are the small particle sizes of the exhaled aerosols. These are smaller than the relevant particle size when tested according to the standard. The protection of FFP2 masks against directly exhaled virus particles is therefore even worse than the measurement according to standard. FFP2 masks are actually designed for coarser dust particles and not for the smallest aerosols. Small virus particles penetrate the masks much more easily, with a penetration of far more than 6%. Unfortunately, we are therefore not at all surprised that so many healthcare workers have become infected despite the use of FFP2 masks.
In health care, for intensive medical care of sick persons, we therefore recommend the use of full protective masks according to EN143.
Here you can find the TV report: https://www.zdf.de/verbraucher/wiso/minderwertige-ffp2-masken-auf-dem-markt-100.html
With the face mask testing devices Mas-Q-Check (incl. Mas-Q-Box) and PMFT 1000 from Palas®, the degree of separation of respiratory masks can be determined quickly and easily in accordance with the new EU directive CWA 17553 . For this purpose, our devices measure the filtration efficiency at 3 µm and thus clearly stand out from other test products.