Masks are the most important protector in the coronavirus pandemic period that caused 150 million people to get sick and more than 3 million people to die, thus affecting the whole world since December 2019. However, in order for the masks to be genuinely protective against the virus, they must be produced under appropriate conditions, have a minimum of 3 layers, and use Meltblown (filter fabric) fabric in the intermediate layer.
Especially in the early days of the pandemic, many companies in Turkey and in the world started to produce masks due to the global shortage in them. However, not every mask meets the necessary requirements.
In order for a mask to be named ‘surgical mask’, it must pass several tests. One of them is the Bacteria Filtration Strength (BFE) value. The BFE value must be 95% and above. Since the protection of the masks that cannot achieve this value is not sufficient, they do not have a surgical mask feature.
Besafe masks with high protection characteristics
Besafe masks developed by Güney Biomedical provide full protection even against the mutations of Covid-19 with a BFE value of 99.8%. Besafe masks, which are newly developed and launched with the slogan ‘‘Effective protection with a single mask instead of 2 masks’’, are the first and only in their respective field.
Enes Güney, Molecular Biologist and Responsible Director of Güney Biomedical, with whom we conducted an exclusive interview, answered our questions regarding the usage of the surgical masks, necessary requirements, and what should be considered in masks.
‘‘High Volume of Unregistered and Unlicensed Mask Production’’
We know that most of the masks sold under the name of ‘surgical masks’ in the market do not meet the criteria. What criteria must a mask meet to be considered a surgical mask?
First of all, surgical masks have the status of ‘medical device’ and are subject to the EN14683 standard as required by the legislation. Through these standards, it is aimed to prevent splashes and infection by protecting the mouth and nose during surgical operations. In addition, it is aimed to prevent the transmission of droplets and particles that are likely to be transmitted by air from the environment to a person or from one person to another by using a surgical mask. In order for a mask to be classified as a ‘surgical mask’, it must comply with EN 14683 criteria.
The most important sub-criterion here is that the BFE (Bacteria Filtration Strength) value is 95% and above. In order to meet these standards, electrostatic meltblown fabric must be used in the middle layer of the mask. In other words, the inner and outer layers of the mask should be made of spounbond fabric and the middle should be made of meltblown (filter fabric) fabric.
Unless meltblown fabric is used, these masks will not be protective since they do not have the filtering feature. Again, surgical masks must meet conditions such as breathability, prevention of splashing, and microbial cleaning. The size of the mask rubber and the size of the nose wire should also comply with the standards. The floor of the production facility should be an epoxy floor in order to prevent dust in the air. The employees working in this hygienic environment must wear gloves and masks.
With the pandemic outbreak in our country, the growing demand for masks has led to an increase in unlicensed and unregistered production. The unlicensed and unregistered masks have no chance of meeting the standards that I have mentioned above. Mask production is carried out to protect human health. The standards of the surgical mask are emphasized in all legislation and documents.
For this reason, businesses that exploit human health need to be strictly supervised and authorities need to approach the issue with more sensitivity. As a society, our most important weapon against the virus is the mask. If this weapon does not meet the necessary conditions, it means that we have a weakness in protection against the virus.
‘‘A Surgical Mask Should Be Renewed every 3 to 4 Hours’’
The general population is using masks for more than 1 year. However, people still do not have the necessary awareness about the use of masks. Can you explain the correct use of the mask?
First off, when the masks are worn by putting the elastic bands behind the ears, they should cover the mouth and nose completely, and the wired part should be adjusted according to the nose. The maximum usage time of a surgical mask should be 3-4 hours. Then a new mask should be used. The old mask should be discarded. While the mask is in our mouth, we should not touch the fabric part of the mask with our hands.
Otherwise, the microbes that have nested on that fabric part will be transmitted to our hands. If we forget or accidentally touch this area, we should wash our hands with soap and plenty of water immediately. If we do not have access to water and soap, we can use a high-grade cologne or disinfectant. Also, when we put on the mask, the pleat or shutter parts of the mask should be facing down. Thus, it will cover the face better and it will be more difficult for the microbes to settle there with the effect of gravity.
‘‘Masks Should Never Be Touched with Bare Hands During Production’’
Undoubtedly, hygiene is one of the most important criteria during mask production. What are the criteria that mask production facilities should have?
Hygiene conditions of mask production facilities should be kept at the maximum level since there is an assignment aimed at the protection of human health. The owners and employees of the mask production business should produce as if they and their family would wear each mask that comes out of the production facility. During the production and quality control phases, masks should never be touched with bare hands and nitrile-derived disposable gloves should be preferred.
The cleanliness of the production environment and the area where the raw materials are stored should be checked frequently and the environment should be disinfected and ventilated at regular intervals. All employees in production must undergo health checks at certain intervals.
‘‘Turkey Missed a Significant Opportunity Due to the Mandatory Grant Requirement’’
Turkey has achieved great success in the production of medical textile products during the pandemic period. What do you attribute this success to? What should be done to increase medical textile exports?
Turkey has a very important experience and culture in textile, and accordingly, it comes right after China in the field of nonwoven and technical textiles production. In fact, the production volume of Turkey was quite high for the country before the pandemic outbreak. With the pandemic, the supply and popularity of this sector have increased substantially. I attribute this success to Turkey’s culture and experience in this business, as well as its qualified workforce. Of course, the creation of a stable environment for investment is another cornerstone of this success.
Unfortunately, the fact that there is a mandatory grant requirement for the export of medical devices and personal protective equipment, which harms the manufacturer’s competitiveness in the global market. While the contribution of the export of the textile products to our current national account deficit as a country is obvious, Turkey missed a very significant export opportunity because of the mandatory grant requirement for medical textile exports.
In order to facilitate the competition conditions of our producers, the grant requirement must be removed as soon as possible. Later, medical textile manufacturers can come together with exporters’ associations to conduct an international PR study. In this way, the popularity and appeal of the quality of Turkish products in the global market will be increased.
As Güney Biomedical, you have the production of surgical masks, N95, FFP2, masks that provide effective protection against mutations of Covid-19. Can you please provide us information regarding your product portfolio and the features of your products?
At Güney Biomedical, we primarily manufacture surgical masks that comply with the ‘‘Type II R’’ standard, which provides the highest standard in surgical masks. We produce these masks in both adult and child sizes.
In addition, we offer our customers a mask that provides full protection against mutations of Covid-19, contains thick filter fabric, and demonstrates double-mask protection.
Apart from that, we manufacture FFP2/N95 type masks that meet the EN149 criteria in 5 layers. These mask models provide both bacteria and particle filtration values above 95%.
Additionally, we can offer a wide variety of color options according to the demands of our customers.
Güney Biomedical possesses both EU and US Certifications
Güney Biomedical manufactures in accordance with European Union standards. Could you please provide information regarding the certificates your company has?
First of all, we provide EN14683 criteria for our 3-layer surgical masks under our CE certificate.
Our company obtained the Type II R qualification report from Ekoteks Laboratories accredited by UAF in Turkey and the Type II R qualification from the Nando-listed Belgium-Centexbel Textile R&D Center approved by the European Commission.
In line with the demands from the United States, we have also received our FDA approval for 2020 and 2021.
In addition, our company currently fulfills the ISO13485 Medical Devices Quality Management System Qualifications along with the ISO9001 Quality Management System.
Finally, I would like to add that we continue all our activities under the Ministry of Health as an Authorized Medical Device Sales Center.
Could you please tell us about Güney Biomedical’s export markets?
Our main export markets are currently France, Germany, Greece, the USA, and Canada. Apart from these, we have also worked in countries such as UAE, Libya, Sweden, and England. In these countries, we aim to increase our marketing investments even more in the future.
‘‘We Have Investment Plans for UK and Germany’’
As Güney Biomedical, you have opened a dealership in the USA. Do you have plans to expand and establish other franchises?
As we know, one of the places hit the most by the devastating coronavirus pandemic is the American continent, including Brazil, the USA, and Canada. In parallel with this, the demands for Medical Devices and Personal Protective Equipment in those countries increased. In order to meet these demands, we are in an active position in the market under the name of ‘‘Guney North America’’ company in Missouri, which is geographically centrally located in the USA.
At the same time, our representative company ‘‘Aama Medical Products’’, which is located in Sweden and covering Scandinavian countries, continues its activities at full speed.
Apart from that, we have future plans to restructure in the UK and Germany in line with the demands in the market.
Interview: Z. Seda Demirdelen, Dilek HAYIRLI