Growing demand for sterile medical devices: BGS stable despite difficult market environment

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Growing demand for sterile medical devices: BGS stable despite difficult market environment

Radiation sterilization for medical devices, implants and pharmaceutical primary packaging is increasingly in demand at BGS Beta-Gamma-Service, also as a result of population growth, and is generating positive figures in this division. By contrast, the stagnation in the construction industry is having a negative impact on the radiation crosslinking division. The company therefore remained stable in the 2023 financial year despite the difficult market environment.

The rising demand for radiation-sterilized medical devices, implants and pharmaceutical primary packaging materials and raw materials had a positive impact on BGS’s business performance with an increase in the low single-digit percentage range. “The medical technology sector is growing, but is also under increasing pressure. An ageing society with increased demand for sterile products and packaging is faced with high costs, including for the implementation of the EU Medical Device Regulation (MDR), which is having a negative impact on investments in Germany and research expenditure,” says Dr. Andreas Ostrowicki, Managing Director of BGS Beta-Gamma-Service.

Structural problems weigh on Germany as a business location

High energy costs and an unchecked increase in bureaucratic regulations weighed on Germany as a business location in 2023. Supply problems with raw materials and possible long-term effects, particularly for plastics and metals, are also having a negative impact. BGS is concerned about business relocations abroad, such as those announced by the chemical industry, and their consequences for the manufacturing industries. “In Germany, the problems of bureaucracy and regulation, energy and logistics costs and the supply of raw materials have been a growing concern for some time. Last year’s interest rate developments had an additional negative impact in this combination,” explains Ostrowicki. “For some manufacturers of medical devices with higher cost pressure, such as single-use devices or products for wound care, a point seems to have been reached where, in many cases, a decision has already been made against Germany as a location for new investments.”

New production space at the Wiehl site

Despite rising energy costs, BGS Beta-Gamma-Service remains committed to its business activities in Germany and is currently making a seven-figure investment in new production space at its founding location in Wiehl, North Rhine-Westphalia.

The most beautiful Christmas card comes from Wiehl: Primary school pupils design Christmas post for BGS

For the second-graders of the Wiehl-Marienhagen Primary School Association (GVB), it is a living tradition: for 16 years, they have been painting the annual Christmas card for BGS as part of a fundraising campaign. The most beautiful Christmas picture was chosen this week at the GVB’s Advent carol singing. Managing Director Dr. Andreas Ostrowicki handed over a donation cheque for 1,500 euros to Headmaster Kai Stäpeler.

“Personal contact and a close partnership with our customers, but also with our immediate region, is very important to us. We are therefore delighted every year with the many creative Christmas pictures from the second classes of the Wiehl-Marienhagen primary school. The best picture traditionally adorns our Christmas card, which we send to our customers and partners internationally,” explains Ostrowicki.

Choosing the best three pictures was not easy this year either. Ronja (7), Anna (7) and David (8) from classes 2a and 2c were lucky and received book vouchers. Their pictures were the most popular of the 72 submitted.

The annual fundraising campaign has been organized jointly by BGS Beta-Gamma-Service and GVB Wiehl-Marienhagen since 2008. This year, head teacher Kai Stäpeler plans to use the donation for the sports hall and new play equipment.

BGS establishes staff position for technology management and reassigns head of application development

BGS has created a staff position for strategic technology management as of 1 July. Dr. Dirk Fischer, PhD chemist and longstanding head of application development at BGS, will take over the management. Marie-Bernadette Watolla will take over as Head of Application Development. After working at B.Braun, one of the leading companies in medical technology, the graduate materials scientist comes back to BGS.

“With the new staff position, we are successfully positioning our service for the challenges of the coming years. Because the key to the development of new technological solutions and the early recognition of industry trends lies in a systematically pursued technology management. In doing so, we will continue to cooperate closely with partners from science and industry,” emphasizes Dr. Dirk Fischer on assuming his new position. Ongoing projects, including the recycling of radiation-crosslinked polyamides, the crosslinkability of biopolymers or alternatives for determining the degree of crosslinking, will thus be transferred to the area of responsibility of the new staff position.

“In order to drive innovation, new technologies must be recognized, evaluated and implemented at an early stage. With the new staff position, we are increasingly tackling technology development, not only in the future-oriented sectors of renewable energies or e-mobility,” explains BGS Managing Director Dr Andreas Ostrowicki. “We are very pleased to have won Dr Fischer as a highly competent and valued colleague for the new task. With more than 25 years of experience in R&D, industrial engineering and technology and innovation management, Dr Fischer brings extensive knowledge to establish and bring to life a systematic technology management process at BGS.”

Marie-Bernadette Watolla takes over as Head of Application Development
Marie-Bernadette Watolla has taken over as Head of Application Development. In future, she will have overall responsibility for the department’s tasks, which include technical feasibility tests and product qualifications in the fields of radiation crosslinking and radiation sterilization. Watolla is thus the new person responsible for the technical implementation, optimization and adaptation of customer-specific requirements for production. “For her new role, Marie-Bernadette Watolla brings years of experience as Deputy Head and Team Leader Sterilization in our Application Development department, as well as valuable practice as Program Manager Sterilization at B.Braun. We are delighted to have won her back as a valued former colleague,” says Dr Andreas Ostrowicki.

Introduction of Cargoclix at the Wiehl site

From 12 June 2023, BGS will implement the online-based time slot planning system Cargoclix for the delivery and collection of goods at the Wiehl site. This was preceded by a one-year usage phase at the Saal site.

Oliver Borsch, the operations manager of the Wiehl site, explains: “The time slot management of Cargoclix has convinced us in the long term at the Saal site, so that a roll-out to the Wiehl site can now be implemented.”

All parties involved benefit from improved plannability of loading and unloading volumes, increased loading performance and transparency regarding free capacities. This is a decisive advantage for the forwarders and also an economic aspect for customers who usually have to pay for waiting times. Due to the introduction of the new system, waiting times for freight forwarders can be reduced by several hours in the future.

BGS customers of the Wiehl location will have the possibility to reserve appointments for deliveries and collections from 12 June onwards. It should be noted that freight forwarders who have not booked a time slot will have to wait for available time slots and should therefore plan for longer waiting times. Booked appointments will be given priority.

Before booking an appointment, it is necessary to set up an account, which only takes a few minutes and is explained in detail by the provider.

Business year 2022: BGS reports slight growth despite difficult general conditions

BGS Beta-Gamma-Service GmbH & Co. KG ended the year 2022 with a low single-digit increase in turnover. The volume growth normalised significantly in the business segment of radiation sterilization involving medical devices, pharmaceutical primary packaging material and implants. Only in the area of the sterilization of consumables for diagnostics was a slight decrease apparent due to the low demand for laboratory capacities. In the business segment radiation crosslinking, the company looks back on a mixed business year 2022. Whereas increases in the crosslinking of cables were recorded, BGS recorded a falling demand for pipes and other crosslinked products. The insufficient supply of raw material and disrupted supply chains of processors caused problems for the plastics industry as a whole.  

“Unstable supply chains and increased energy prices have posed challenges for us in 2022,” comments managing director of BGS, Dr. Andreas Ostrowicki. “The tight supply of material and raw material supplies has resulted in bottlenecks in the production of products for many of our customers. This also affected us as commissioned provider of crosslinking and sterilization services. Despite the difficult general conditions for society as a whole, we nevertheless managed to get through the year quite well,” explains Ostrowicki.

A particular challenge in the field of radiation sterilization were the stricter official requirements for the transport of cobalt-60 sources. “The necessary and punctual reloads of the gamma plants were not possible last year – this led to a substantial shortage of sterilization capacities and puts pressure on the entire medical device industry in Germany.” In order to ensure a supply of crucial, sterile medical devices to the market, managing director Ostrowicki appeals to politicians to create the necessary general conditions and to give higher priority to the issue of sterilization of medical devices.

Looking ahead to the 2023 business year

Despite continually higher energy costs, managing director Ostrowicki believes his company is well prepared for the current business year. “We have undertaken in-house efforts to improve our process quality, save energy and further automate the plant technology,” explains Ostrowicki. “In addition, we expect to complete our planned construction at the headquarters in Wiehl around the middle of the year.” With this extension, BGS is creating around 1000 sqm of new space for logistics and production and is investing in the research and development work of the company with a new laboratory. The focus of the R&D activities is on the development of new crosslinkable materials, the recyclability of radiation crosslinked plastics as well as the use of radiation crosslinked biopolymers in the most diverse technical applications.

Biopolymers: New application possibilities in electronics and electrical technology through radiation crosslinking

Products in the electrical technology and electronics (E&E) industry have to meet high flame retardant standards and often demanding thermal requirements. Polymers available on the market so far do not meet these requirements. A joint research project between the German research institutes Fraunhofer IAP and Fraunhofer WKI, BGS and several industrial partners has achieved the first successes in the development of bio-based flame retardants in bioplastics. As a result, plastics out of 100 percent bio-based materials could be used in electronics and electrical technology in the future. The processing was tested within the scope of the research project by means of compounding, injection moulding and additive manufacturing.

During the three-year research project, several objectives were in the focus concerning the development of new bio-plastics and bio-composite materials for applications in electronics and electrical technology. Key priorities were to develop a halogen-free flame retardant (additive) that can be used in bio-plastics if possible in low quantities and with low costs, and to clarify to what extent radiation crosslinking is able to further improve the flame retardancy of the material. “In the course of our sub-project on the effects of electron radiation on the new materials, we defined three objectives,” explains Dr. Dirk Fischer, head of application development at BGS. “Through crosslinking of the new bio-based material, we wanted to increase the flame retardant effect on one hand and on the other hand, achieve a bonding of the flame retardant to the biopolymer. In addition, we wished to verify the crosslinkability of biopolymers already available on the market, in particular, in different formulations and using wooden particles. The results with regard to the crosslinkability and the changes in properties arising therefrom make us confident that new applications for bio-based plastics formulations will emerge from this in the areas of electronics and electrical technology,” Fischer goes on to say.

Newly tested: Electron radiation crosslinking bonds flame retardants to bio-plastic polylactides (PLA)

In order to achieve optimal flame retardancy, it is necessary to distribute the flame retardants homogeneously in the biopolymer matrix out of PLA. The bonding with the biopolymer matrix should be achieved through the specially developed reactive flame retardants. As a new procedure for the bonding of the flame retardants to the matrix, radiation with accelerated electrons (electron radiation) was used. This non-thermic process has been used for many years to improve the properties of bulk plastics and technical plastics and is a standard technique in numerous industries; radiation crosslinking, however, has received little attention so far in the area of bio-plastics. The properties of the polymers are modified here by triggering controllable crosslinking and bonding reactions via the radiation dose. In the tests, an additive proved to be effective where the crosslinking reaction of the PLA demonstrably outweighed the degradation of the polymer through irradiation. Other additives were also tested extensively. “The results improve the level of knowledge about the additives partly used for the first time as well as the processes in the plastics processing,” explains Fischer. “In particular, we were able to demonstrate through this the effects of the irradiation on the crosslinkability of these new bio-based formulations.”

Compounding with bio-PA: Testing flame retardants and radiation crosslinking

In addition, flame-protected formulations were developed in the course of the research project on the basis of bio-polyamides (PA) for injection moulding, and the crosslinkability was examined for the first time under the influence of electron radiation. “It showed that the bio-polyamides used here, namely PA6, PA10 and PA11 can be very effectively crosslinked with the help of a crosslinking additive and have no disadvantages whatsoever compared to conventional fossil-based plastics,” according to BGS project manager Fischer. The positive effect of adding wooden particles to the flame retardant performance could also be demonstrated. As in previous tests with PLA and PBS, the heat release rates were reduced through the addition of wood while shortening the ignition times simultaneously. The promising results are the subject of further research activities. “The crosslinking of the developed materials results in a new properties profile. In the case of nearly all the PA-based formulations, we were able to document an increase of tensile strength and the elastic modulus under tension, with reduction of the notched impact strength,” explains Fischer. “The project has also proven that the production of crosslinkable formulations and their processing shows many parallels to well-known conventional plastics. Bio-based plastics can therefore replace conventional plastics in many applications and their properties spectrum can be further optimised through radiation crosslinking. This not only opens new possibilities in the areas of electronics and electrical technology, but also creates new areas of application in the automotive industry – there is enormous potential here.”

Funding

  • Project title: Development of new applications for bio-plastics and bio-composite materials in electronics and logistics using halogen-free flame retardant systems
  • Funding bodies: Federal Ministry of Food and Agriculture (BMEL)
  • Promoters: Fachagentur Nachwachsende Rohstoffe e. V. (FNR)

Project partners

  • Fraunhofer WKI
  • Fraunhofer IAP
  • Clariant Plastics & Coatings (Deutschland) GmbH
  • Linotech GmbH
  • Hesco Kunststoffverarbeitung GmbH
  • Kabel Premium Pulp & Paper GmbH
  • Hager Electro GmbH
  • Rettenmaier & Söhne GmbH
  • Georg Utz GmbH

Project team:

Front row from left to right: Dr. Jens Balko (Fraunhofer IAP), Marc Mohring (J. Rettenmaier & Söhne GmbH), Dr. Antje Lieske (Fraunhofer IAP), Jochen Rausch (BGS), Katharina Krupp (BGS) Michaela Loos (BGS); Back row from left to right: Reinhard Lorenz (Georg Utz GmbH), Bernd Nass (Clariant Plastics & Coatings GmbH), Dr. Arne Schirp (Fraunhofer WKI), Andreas Neufing (Hager Electro GmbH), Dr. Dirk Fischer (BGS).

New head of operations and production at headquarters in Wiehl

With Oliver Borsch, BGS has had a new head of operations and production at its headquarters in Wiehl (North Rhine-Westphalia) since the beginning of January. The trained engineer comes from the aerospace supplier Safran Cabin Germany where he was, amongst other things, head of supply chain management as well as most recently, director of operations. He will assume the management of production and logistics at the headquarters in Wiehl including personnel and technical responsibility. 

“I am fascinated by the underlying business idea at BGS, the variety of application possibilities radiation crosslinking and radiation sterilization offer, and the resulting diversity of partners and customers,” comments Oliver Borsch on his new position at BGS. “In my function as operations manager, it excites me to be able to incorporate my knowledge and experience, for example, in production organisation and shop floor management. Moreover, I am looking forward to discovering and learning new things, such as the technologies used by BGS.”

In his new position, Borsch considers himself responsible for the employees of BGS apart from his task of production organisation: “I have had good experience with continuous improvements of processes and workflows and would like to build on this. It is not about the big plunge that changes everything, but about regular small steps, based on ideas of the team that we pick up on and implement. The exchange with colleagues is important to me in this context: Colleagues imbue the corporate processes with life and are absolutely at the forefront for me as new operating manager,” emphasises Borsch.

“With his many years of experience in supply chain and production management, Oliver Borsch brings along all the requirements to look after production and logistics at BGS optimally, while observing our very high quality standards,” says managing director Dr. Andreas Ostrowicki. “Mr. Borsch is starting his job in a very active phase of our company: Currently, Wiehl is expanding its logistics and production spaces. In addition, we are expanding our laboratory capacities for radiation crosslinking,” Ostrowicki goes on to say.

More capacity through expansion at location in Wiehl

With the expansion of the laboratory and the spaces for logistics and production in Wiehl, BGS is meeting the increased demands placed on material tests for radiation crosslinking as well as the rising demand for sterilization services in the sectors of biotechnology, medicine and diagnostics. The additionally planned spaces amount to approximately 1,000 sqm. In total, BGS is making investments for the expansion in the mid-seven digit range. The work is to be completed by the middle of the year.

One of the best: two awards for BGS trainee

Outstanding performance: 522 trainees out of a total of 10354 examination participants in around 150 different professions completed their training with a “very good” in the 2022 final examinations of the Cologne Chamber of Industry and Commerce. The Cologne Chamber of Industry and Commerce celebrated this special achievement at the end of October together with the top trainees, their training companies, vocational schools and other guests. Also present at the award ceremony was our trainee Marko Kürti, who completed his training as a machine and plant operator in the field of plastics and metal with excellent results. Due to the very good graduation of our apprentice, BGS is at the same time one of the training companies that were honored for outstanding achievements in vocational training.

 

 

 

A lot of praise for Marko Kürti and three other year’s best there was then again last Tuesday, 13.12.2022 from the IHK Oberberg and the Wiehl mayor Ulrich Stücker. In the context of the meeting of the city council he presented certificates and gifts and congratulated warmly on the successful examinations. Ulrich Stücker wished all successful examinees continued success and joy for their professional and personal life. For more information, visit (text in German) https://www.wiehl.de/aktuelles/nachrichten/8210-viel-lob-fuer-die-jahrgangsbesten.html.

 

 

Photos:

Marko Kürti with Stefan Semmel, Head of Processes and Technology at BGS ©IHK Köln / Schmidt-Dominé

Mayor Ulrich Stücker honoring the best apprentices ©Christian Melzer

Discussions on security of supply dominate this year’s BGS Irradiation Service Days

Exclusive white papers, PDFs and videos for all presentation topics now available free of charge

Wiehl, 11 October 2022 – With the BGS Irradiation Service Days (ISDbyBGS), BGS Beta-Gamma-Service hosted a virtual trade fair on radiation sterilization at the end of September for the second time in a row. On 28 September 2022, experts from business, research and associations joined to analyse current trends and industry-specific themes in lectures, discussion forums and guided virtual tours that revolve around the use of beta and gamma rays in the sterilization of products for the medical technology and biotechnology industry. Exclusive white papers, PDFs and videos on all presentation topics may be called up free of charge until August 2023 after registering on our virtual trade fair platform at https://isd22.bgs.eu/.

The discussion panels at this year’s Irradiation Service Days were primarily dedicated to security of supply in the medical device market. Representatives from industry and associations discussed the current problems in the sector such as shortage of raw materials, supply bottlenecks and high bureaucratic hurdles in the transport of Cobalt-60 sources. The experts from BVMed, Ypsomed and BGS agreed that there was sufficient Cobalt-60 to operate the gamma irradiation facilities, but that due to tightened regulations for transportation companies, it could not be imported to Germany at the moment. This situation affected the entire industry in Germany and, at the same time, had an impact on the whole of Europe. Operators of gamma plants had been under pressure for months as a result of lacking reloads of their facilities.

In view of the Cobalt-60 deliveries, there was a consensus that bureaucracy severely disrupted the functioning of supply chains and made it increasingly difficult for providers of sterilization services and medical device manufacturers to remain operationally functional. “If politics does not take action soon, the lacking reloads will result in further capacity loss and continue to aggravate the already strained market supply of sterile medical devices in the coming months,” explained Thomas Oestereich, Distribution Manager at BGS.

The strained situation of sterilization capacities was also reflected in a survey carried out amongst participants of the virtual trade fair. Asked about the biggest challenge concerning the sterilization of their products, 33 percent stated the availability of sterilization capacities, closely followed by too little know-how about sterilization processes in their own companies (30 percent).

For about one year: Material for downloading free of charge

As of today, video recordings are available of all presentations in the virtual trade fair spaces. In addition, a number of exclusive white papers and complementary material can be downloaded free of charge. After registering at https://isd22.bgs.eu/, those interested can access all recordings and material until August 2023.

BGS Irradiation Service Days 2022: Two-thirds of the participants expect property improvements in applications using radiation crosslinking

Exclusive white papers, PDFs and videos for all presentation topics now available free of charge 

Wiehl, 11 October 2022 – With the BGS Irradiation Service Days (ISDbyBGS), BGS Beta-Gamma-Service hosted a virtual trade fair on radiation crosslinking at the end of September for the second time in a row. On 29 September 2022, experts from science and the industry joined to analyse current trends and industry-specific themes in lectures, discussion forums and guided virtual tours that revolve around the use of beta and gamma rays in the crosslinking of plastics. Exclusive white papers, PDFs and videos on all presentation topics may be called up free of charge until August 2023 after registering on our virtual trade fair platform at https://isd22.bgs.eu/

Visited by experts from the plastics industry, as well as the automotive, cable, pipe, and hose industry as well as mechanical engineering, the trade fair impressed its visitors in particular with the basic lecture “Crosslinking of thermoplastics and elastomers”. In addition, industry-specific presentations such as “Benefits of radiation crosslinking for automotive applications” and “Second source crosslinking of continuous products” convincingly illustrated the advantages of crosslinked plastics for numerous applications. Discussions about the basics, applications, plant technology, and process technology of radiation crosslinking revealed the high degree of knowledge among the participants who joined the live conferences.

Particularly well attended were the short impulses of experts from the University of Aalen, the Institute of Polymer Technology and Ascend Performance Materials on the future of radiation crosslinking. The lecture topics on recycling of radiation crosslinked polyamides, general application-related potentials of radiation crosslinking as well as concrete applications in the electrical industry also provided an introduction to the ongoing R&D projects of BGS with its research partners.

Potential of radiation crosslinking in the property improvements

According to a survey at the BGS Irradiation Service Days, two-thirds of the participants regard the largest potentials of radiation crosslinking in the property improvements of their products. At the same time, over half of those questioned said that they are not yet currently using the technology. “Transfer of knowledge and the personal exchange with customers as well as specialists in research facilities were in the foreground at this year’s BGS Irradiation Service Days. Together with our partners, we actively raise awareness about the benefits of radiation crosslinked plastics,” explained Managing Director of BGS, Dr. Andreas Ostrowicki.

For about one year: Material for downloading free of charge

As of today, video recordings are available of all presentations in the virtual trade fair spaces. In addition, a number of exclusive white papers and complementary material can be downloaded free of charge. After registering at https://isd22.bgs.eu/, those interested can access all recordings and material until August 2023.