Certified quality management, mask standards, CE marking for personal and medical protective equipment (PPE) in the European Union, traceability, corporate due diligence for highest quality – discussion contribution by Max Leber, Managing Director PPE Germany GmbH in Berlin.
To ensure the highest quality and safety of FFP2 masks as personal and medical protective equipment, certification is mandatory. An exemption based on the European Union Recommendation (2020/403 of 13 March 2020), which provided that personal and medical protective equipment could be placed on the European market without CE marking for a limited period of time, is no longer in force since 01 October 2020. This exemption also meant that counterfeit goods were not allowed, yet the incidence of counterfeit goods with misleading labelling increased, as confirmed by market surveillance authorities, and had been available in Europe’s pharmacies, medical supply stores and also supermarkets. Authorities even assume that billions of faulty respirators without certification were stored in the Federal Republic of Germany alone, and some are still stored today.
PPE Germany GmbH, the leading mask manufacturer in Berlin, places great emphasis on careful quality control in order to guarantee the strict EU guidelines and requirements for optimal protection with the use of mouth-nose covers, medical face masks as well as particle-filtering half masks (PPE masks).
Material procurement for highest quality
Personal protective equipment is used throughout the commercial sector, health services as well as by sovereign organisations such as the fire brigade, police or military. No mask can guarantee 100 per cent protection, because a large part of the filtering effect is achieved by electrostatic charge. This is comparable to the principle of a balloon rubbing against a jumper, explains Hendrik Bierhorst, quality manager at PPE Germany GmbH. Vires and bacteria do not have an electrically charged surface, which is why they are attracted to the opposing charge of the mask and over 94 per cent protection can be achieved. „But the charge of the mask decreases over time, despite original packaging and correct storage, and thus loses some of its filtering effect,“ explains Hendrik Bierhorst.
In the quality assurance of FFP2 masks Made in Germany, another focus is on the topic of material procurement and direct supply chains to enable precise control and traceability of the raw materials used. To ensure high quality, the materials must meet the strict requirements for protection and must not contain any substances that are hazardous to health.
Production process for maximum safety
The masks are produced in a special clean room to avoid any contamination. The clean room is subject to high standards and is regularly checked for cleanliness and possible contamination. Hendrik Bierhorst explains that the manufacturing process is subject to strict quality controls, which ensure that only flawless masks are brought to market to ensure that the masks provide perfect protection.
„An important aspect of quality control is risk management,“ Bierhorst explains. Here, possible risks are recorded and specifically minimised. Higher requirements apply to quality controls of medical masks. „The Dodo Air Medical model, type II with approval as PPE class FFP2, CE-certified according to the EU CE 2233 standard and approval according to EN 14683:2019-6, offers 98 per cent filtering performance for viruses and bacteria with high wearing comfort due to low breathing resistance up to 160 Pa,“ adds Hendrik Bierhorst.
Mask wearers have individual requirements
The consideration of individual needs and requirements in the production of medical FFP2 masks brought the product Dodo Air Medical. In discussions with medical staff, there was criticism that masks were considered a nuisance when worn for long periods of time during the working day. „During the pandemic in particular, masks sometimes had to be worn for up to eight hours, so the wearer’s comfort becomes an enormous issue,“ says Bierhorst. Skin tolerance and types of resistance levels emerged as crucial challenges. „With the Dodo Air Medical, this product differs from other products not only in its high filter performance, but also in its very good wearing comfort, because the external resistance is very low.“, says Bierhorst. One advantage is the rectangular shape of the Dodo Air Medical masks, which creates less pressure, making breathing easier and at the same time achieving 98 percent protection.
Mouth-nose covering: durability and disposal
Mouth-nose protection masks are stored not only in public and commercial facilities, but also in private households. These masks have the required CE certification, a four-digit test number and correct labelling, yet they have a minimum shelf life. An expiry date for FFP2 masks is surprising, because why would a product made of cotton fabric and meltblown fleece (high-tech plastic fabric) go bad? The answer lies in the high-tech plastic fabric, which is endowed with physico-chemical properties. These properties must be ensured and maintained during the service life of the FFP2 masks without any loss of quality, which is why studies by the Max Planck Institute have proven that the functionality of the FFP2 mask expires after a period of two to five years. Since 07 April 2023, the mask obligation has expired in Germany. Used masks are to be disposed of in the residual waste and expired masks can be handed in at special collection points for medical waste at municipalities in Germany, for example.
Managing Director and Sales
PPE Germany GmbH
PPE Germany GmbH
Tel: +49 30 202366380
Contact: Max Leber, GF and Sales
PPE Germany GmbH
Phone: +49 30 202366380
PPE Germany GmbH, based in Berlin, are specialists in respiratory protection Made in Germany. PPE Germany is one of the major European mask producers for high-quality FFP2 masks and started production in 2020 to ensure the supply of protective equipment to the population. PPE Germany protects the health of people who have to work and live in complicated air conditions, for example viral contamination, hospital germ contamination, bacterial contamination, dust, fibres (e.g. from mineral wool), industrial fumes, fine dust. All PPE Germany products are certified and subject to the strictest testing standards. More information at: https://ppegermany.de
How can I be sure that the FFP2 masks I buy are of the highest quality?
As a purchaser, you should ensure that the FFP2 masks you buy are subject to certification and provide traceability. Careful sourcing of materials and quality controls during the manufacturing process are other important factors to ensure perfect protection. PPE Germany GmbH, as a leading mask manufacturer, places great emphasis on careful quality control, working closely with experts from Dodo Air Medical to ensure the highest standards.
How is it ensured that the FFP2 masks are not contaminated or damaged?
The masks are produced in a special clean room to avoid any contamination. The clean room is subject to high standards and is regularly checked for cleanliness and contamination. The manufacturing process is subject to strict quality controls to ensure that only flawless masks are brought to market. In addition, product traceability is ensured in order to be able to react quickly in the event of any problems.
How are the FFP2 masks continuously improved?
PPE Germany GmbH works closely with experts from Dodo Air Medical to keep the FFP2 masks at the cutting edge of technology and to improve them. The Dodo Air Medical product is an important component in optimising the masks. It is a special filter that ensures even better breathability and thus greater wearing comfort. By working closely with Dodo Air Medical, PPE Germany GmbH is able to keep the masks at the cutting edge of technology and ensure the highest quality and safety standards.