News Archive

On April 16 and 17, 2024, the online meeting of Working Group 1 "human-medicine area" took place under the leadership of convenor Professor Katrin Steinhauer.

Several strategically important projects are supported by various scientists from Dr. Brill Institutes. For example, Dr. Dajana Paulmann is in charge of the development of the 4-field test in the area of virucidal testing, where data from the latest round robin test has been discussed. In addition, we are also part of the group for the qualification of reference substances for various test viruses. Dr. Florian H. H. Brill, together with Dr. Dajana Paulmann and Dr. Britta Becker, has also taken over the project management for the replacement of the poliovirus in EN 14476, which is to be completed by 2026. Additionally, Dr. Brill, together with Anna Ulatowski, is running the project to revise EN 14348 for mycobactericidal effectiveness testing. Henrik Gabriel provides significant support for the revision of the EN 14561/2/3 standards.

For Dr. Brill, involvement in these committees is a matter of course and is part of the company's DNA.

Dr. Brill Institutes offers important new support for hand disinfectant manufacturers

The Europe-wide introduction of the EN 17430 standard will revolutionize the efficacy evaluation of hand disinfectants in the medical sector.

Dr. Brill, what makes the new EN 17430 standard so important?

Dr. Florian Brill: "The standard represents a milestone in infection prevention with regard to evaluating the effectiveness of hand disinfectants. Until now, the effectiveness of these products against bacteria was tested in practice in accordance with EN 1500. Now, for the first time, the products can also be tested on test subjects against viruses. The standard therefore brings with it completely new requirements for hand disinfectants. Many products on the market now have to be tested in accordance with the standard. For us, this test procedure further rounds off our product range."

Dr. Paulmann, your laboratory team in Bremen was involved in the development of the standard for Dr. Brill Institutes and will continue to test products for customers in the future. What is so special about the new test procedure?

Dr. Dajana Paulmann: "It's a next-level test. We are testing whether the disinfectant virucides are effective on the surface of the hands. To this end, they are now being tested on at least 18 test subjects whose hands have been contaminated with the murine norovirus, which can only infect mice. Until now, the virucidal effect according to EN 14476 has only been tested in test tubes, which is not very practical because hands have a complex surface structure. Everyone on the market is familiar with the EN 1500 standard, which is used to test against bacteria. EN 17430 is the further development for testing against viruses."

For how many companies is the new standard relevant?

Dr. Florian Brill: "We can assume that between 50 and 100 manufacturers across Europe with up to 1,000 products will have to tackle the new tests. If you don't test, you risk a downgrade in the efficacy level. Products may then no longer be used in hospitals because their virucidal efficacy is no longer proven. The development of this standard began around ten years ago. We were involved the whole time - both in the experimental development of the test procedure and in drafting the text. There is no fee for this development work. But customers know that we are very familiar with the topic because we have been working on it for a long time."

How long do customers generally have to prepare for the test procedures?

Dr. Dajana Paulmann: "Companies now have 18 months to have their products tested in accordance with the new standard. The test is time-consuming and therefore takes around six to eight weeks. However, we have been offering a screening procedure for some time now, which has already been taken up. This works with five test subjects, only takes up to four weeks and provides customers with an initial impression of whether the product meets the requirements of the new test procedure. Anyone who then orders the entire test in the second step will, of course, be reimbursed for the screening procedure."

Is your development work in this area complete with the publication of the standard?

Dr. Florian Brill: "No, we will continue to work on the topic in order to ensure patient safety in the best possible way. As the new standard has so far only been tested with the murine norovirus, we are already researching other viruses for this practical test. There is definitely further research interest in this area."

The first movers started work today at our main site in the north of Hamburg. We will of course remain at our location in the beautiful Hummelsbüttel district, but will be moving into great new premises in the immediate vicinity. We are really looking forward to it! And of course we will keep you up to date with any further news about the move.

In April 2024, our Institute for Antifouling and Microbiology will be represented at the Sustainable Shipping Conference 2024, the "6. Bremer Kongress für Nachhaltigkeit der Schifffahrt", with a co-lecture entitled "Antifouling – Notwendigkeit und Perspektiven" (Antifouling - Necessity and Perspectives). Speakers: Dr. Burkard Watermann, LimnoMar, and Bernd Daehne, Dr. Brill + Partner GmbH Institute for Antifouling and Microbiology - as part of Workshop 2: Biofouling. The congress will take place in German on 22-23 April 2024, in the city of Bremen. We would be very pleased about your participation! All information on the content and for your free registration can be found under the following link:
Sustainable Shipping Conference 2024

In the brandnew paper Wiegand et al. 2024 (International Wound Journal, in press) we are presenting parts of our data from our InVitroWound project which was granted by BMBF call "Alternatives to animal testing". In cooperation with PD Dr. Cornelia Wiegand from the University Medical Center Jena we developed an infection wound model based on artificial 3D skin. In this assay we can test antimicrobial wound are products without animals on their antimicrobial, biocompatibility as well as healing performance. This is a milestone in practice-like in-vitro testing with new endpoints.

If you are interested in the data or performing such studies please feel free contacting us.

UPDATE: On 13 March 2024 the paper "A standardized wound infection model for antimicrobial testing of wound dressings in vitro" hat been published. Link: here

DR. BRILL INSTITUTES is engaged in several expert groups to contribute continuously to the scientific know-how for patient and environmental safety.

In February Dr. Florian H. H. Brill participated as Convenor of the Working Group 5 in the high-level CEN and CENELEC TC 216 plenary meeting with the who is who of efficacy testing of disinfectants and antiseptics in Lille hosted by Laboratoires Anios with Sophie Loeffert-Frémiot and led by the chairwoman Christine Roques. A number of important strategic decisions were made.

In March Dr. Florian H. H. Brill participated in the Working Group 3 meeting of CEN TC 216 in Milano. He reported from his strategic working group 5 as well as the on-going projects for developing a phase 2 step 2 test for surface disinfection with mechanical action for WG 3 applications e. g. in food and feed area with an innovative automated application procedure.

Also, in March our surface disinfection expert Anna Ulatowski will report in the German mirror committee for WG 2 and 3 on the projects of PAS 2424 into an EN method and her development of a phase 2 step 2 surface disinfection test with mechanical action using an automated application procedure. Anna's Method for better standardization of drying microorganisms was published as part of the new EN 13697 in January.

With the paper Konkol et al. we aimed to develop a method to assess the virucidal performance of domestic laundry in a lab-scale washing machine (Rotawash) based on EN 17658 in Cooperation with Henkel. The method developed was led by our joint PhD student Justyna Konkol in cooperation with the Henkel team led by Dr. Mirco Weide in Düsseldorf, our Dr. Brill Virus experts in Bremen Dr. Britta Becker and Dr. Dajana Paulmann as well as from our cooperation partner Professor Dr. Eike Steinmann from Ruhr-University Bochum, Professor Dr. Andreas Dotzauer from University Bremen as well as our Dr. Brill + Prof. Bockmühl lab director Dr. Britta Brands from Kleve.
 
With this great team approach we are now prepared to test domestic laundry detergents against e. g. Vaccinia and Norovirus. If you are interested or have questions please contact us. Link to publication: Here

From 18 - 19 April 2024 you can find out from experts which aspects of hygiene need to be taken into account in the context of the Medical Device Regulation MDR. Together with NSF Prosystem, a competent partner in medical technology, DR. BRILL INSTITUTES is organizing a seminar on this topic. We look at various factors that play a role in placing reprocessed medical devices on the market so that you have an improved understanding of the reprocessing validation processes. So, if you produce reprocessable medical devices, are a supplier to manufacturers of medical devices or generally deal with the topic in the context of quality management or regulatory affairs, we look forward to welcoming you to Hamburg after registering using the following link: here (The seminar will be held in German.)

Our Institute for Antifouling and Microbiology will be represented by Bernd Daehne as a speaker at the webinar in German language "Blauer Engel für Unterwasserbeschichtungen und andere Bewuchsschutzsysteme (DE-UZ 221)" (Blauer Engel for underwater coatings and other anti-fouling systems (DE-UZ 221)". His topic: Presentation of the award criteria "Effectiveness". The webinar will take place on 21 March 2024 and we look forward to your participation! All information on the content and your free registration can be found under the following link: Blauer Engel webinar

With a real "dream team", Dr. Brill Institutes will be able to offer customers from industry its own Regulatory Service in the future. Heike Schimmelpfennig and Dr. Gunnar Kleist, each with two decades of regulatory experience in different areas of industry and public authorities, offer a 360-degree view of chemical testing and approval of biocides (active substances and products).

"With our wealth of experience from different perspectives, we are unique on the market," explains Dr. Gunnar Kleist confidently. "We offer our customers holistic project management, which can take five years from the first kick-off meeting to approval, depending on the process." The two are more than trustworthy sparring partners in a process that demands complete transparency and honesty from the customer.

Thanks to its many years of experience, the Regulatory Services team is also able to master critical situations at short notice when companies get lost in the complex European chemicals legislation or miss important deadlines, which can sometimes threaten their existence. However, both prefer to work with the customer from the start of the process in order to avoid precisely such crisis situations.

"In our role, we also see ourselves as a mediator between the needs of industry and the expectations of the authorities," says Heike Schimmelpfennig. "We know what the authorities want, but we also know the needs of industrial customers."

Heike Schimmelpfennig has ten years of experience in the environmental risk assessment of chemicals in both a consultancy firm and an EU regulatory authority. Dr. Gunnar Kleist contributes his more than 20 years of corporate experience in industrial research, test method development and Regulatory Affairs. Their joint core competence is to incorporate all relevant information from their profound knowledge of internal company processes into an approval application in such a way that a smooth and successful completion of the entire procedure is guaranteed.

The Regulatory Services are an independent island in the Dr. Brill family because their services can be booked independently of laboratory operations. The efficacy tests required for product approval can, but of course do not have to, be commissioned from Dr. Brill + Partner. However, the short line to the technical expertise of the associated test laboratories and the possibility of commissioning time-critical data packages at short notice within the network can be a decisive advantage for the customer in the approval process.

Dr. Florian Brill, Owner and Managing Director of Dr. Brill Institutes, sums it up: "With the integration of Dr. Brill Regulatory Services GmbH into the Dr. Brill Institutes Group, we have gained a decisive new building block that will help us strategically. We are bringing regulatory expertise in-house. A large part of our work in the various laboratories results in an approval dossier according to BPR, for example, and now we can deliver this. Dr. Brill Regulatory Services was the missing component - and with Gunnar and Heike we have gained two superstars of the scene. I want them in my team and so do our customers. I'm really looking forward to everything else."

In the coming weeks and months, the new Dr. Brill Regulatory Services team will be presenting itself to clients at conferences and presentations. Dr. Gunnar Kleist: "It is important that clients build up a basis of trust with us and also realize what makes us special. That we don't do anything by the book, but always create the best case for the customer. As a rather small team, we deliver what we promise with our personal expertise!"

If you would like more information about our new service, please contact Heike Schimmelpfennig (heike.schimmelpfennig@brillregulatory.com) or Dr. Gunnar Kleist (gunnar.kleist@brillregulatory.com).

As part of the free Online Update #14 on the topic of "Sustainable hygiene", you will have the opportunity to find out about important questions on the topic and exchange ideas with experts from the clinical, research, political and industrial sectors. The online update is a cooperative event with DR. BRILL INSTITUTES, MedWiss4you and HIHeal and will be held in German language. All information on the content and for your registration can be found under the following link:
#14 - Nachhaltige Hygiene

Dr. Brill Regulatory Service GmbH was recently integrated into the Dr. Brill Institutes. This also opens up new perspectives and synergy effects for Hydrotox.

With a real “dream team”, the Dr. Brill Institutes will in future offer customers from the industry their own regulatory service. Heike Schimmelpfennig and Dr. Gunnar Kleist, each with two decades of regulatory experience in different areas of industry and public authorities, offer a 360-degree view of chemical testing and approval of biocides (active substances and products). In conjunction with the GLP laboratory at Hydrotox, this also opens up new perspectives in the planning of tests and the evaluation of results. Further information can be found at Dr. Brill Regulatory Services GmbH.