With Sarah Haufe, BGS has a new manager for quality assurance since mid-April. The engineer and trained quality auditor comes from Biovegan GmbH, where she was most recently responsible for quality management and the areas of production and storage as a member of the management board. At BGS, Sarah Haufe is in charge of quality assurance in the business areas of radiation sterilization and radiation crosslinking.
As head of quality assurance at BGS, Sarah Haufe works closely with all business divisions and is responsible for carrying out and monitoring external and internal quality management audits. She heads the department of quality management at the different locations and is responsible for all employees from the test laboratories, quality assurance and management departments at the company’s headquarters in Wiehl, as well as the sites in Bruchsal and Saal an der Donau.
“We are pleased to have been able to recruit Sarah Haufe, an experienced leader and quality manager,” said Managing Director of BGS, Dr. Andreas Ostrowicki. “We shall continue to develop the stringent quality system at BGS together with Ms. Haufe with respect to regulatory requirements and standards as well as the needs of our customers.”
“The creative opportunities and challenges at BGS as a strongly growing company are very appealing to me. As head of quality assurance, I am looking forward to being part of this development and continuously optimising the existing business processes in direct cooperation with the management,” says Sarah Haufe.
Quality assurance and certifications at BGS
BGS has a stringent and sophisticated quality system that is being consistently enhanced. The quality management system of our company is certified pursuant to the standards ISO 9001, DIN EN ISO 13485 and EN ISO 11137. In addition, BGS is registered with the FDA and has the JAPAN PAL certificate for all three locations, which is a prerequisite for the approval of medical devices in Japan.
BGS continues to expand: Following around ten months of construction, we have now taken a new logistics hall into operation at the Bruchsal location and with this addition, more than doubled the previous space.
The market for in-vitro diagnostics, laboratory supplies and medical devices is growing and for several years now, it has ensured a steadily rising demand for sterilization capacities. In addition to the gamma irradiation facility at the headquarters in Wiehl (North Rhine-Westphalia), BGS has been operating a new, ultra-modern plant at the location in Bruchsal since 2018 to manage these growing capacities. Its activity has increased continuously since then. “Of course, the increased output requires more logistics space, which led us to start the planning of a new storage hall on the existing premises of the company grounds already at the end of 2019,” explains Managing Director Dr. Andreas Ostrowicki. The start of construction of the new building in April 2020 was preceded by extensive demolition works of the old building as well as earthworks.
Further increase in expendable medical items during the corona pandemic
“Since the beginning of the corona pandemic, the need for laboratory consumables and primary packaging material for the pharmaceutical industry has risen significantly once again, and correspondingly, the need for sterilization capacities,” continues Andreas Ostrowicki. “Similarly, the increased demand for single-use products required for the production of corona vaccines is clearly evident. Through the construction of the new hall, we have created urgently needed storage space to cater to the further expansion of these capacities. Furthermore, the expansion allows an even more efficient handling of the flow of goods, while ensuring that regulatory requirements are fulfilled, for example, the separation of non-irradiated and irradiated products.”
Wiehl, 23 March 2021 – BGS Beta-Gamma-Service GmbH & Co. KG continues its expansion: In particular, the pandemic-related rise in demand for sterilization capacities for biotechnological products and pharmaceutical primary packaging material ensured sound revenue increases. Only last year in 2020 did BGS invest eleven million euros in the expansion of its facilities and locations. This year sees further investments in the mid-seven-digit range.
Health protection through sterile products: With the sterilization, for example, of medical disposables such as catheters or laboratory consumables, BGS provides a systemically relevant service not only in the pandemic. “Sterilization with rays is generally an indispensable method of producing sterile products for health care. In the past year, we were also able to record a significant surge in demand for biotechnology products, consumables for laboratories and primary packaging materials for the pharmaceutical industry,” explains Managing Director of BGS, Dr. Andreas Ostrowicki.
In addition, the stable development in the construction industry resulted in a slight increase of sales in the other business division, namely radiation crosslinking of plastics: “With the help of radiation crosslinking of tube and rod products to name a couple of examples, we ensure the usage properties of systems implemented in new buildings or renovation projects,” declares Ostrowicki. The high degree of material stability of crosslinked plastics is especially relevant for lightweight construction in the field of electromobility. BGS expects an increasing demand this year for radiation crosslinked components in the automotive industry.
Investments in expansion of capacities
In order to cater to the increased demand especially in the area of sterilization, BGS invested in the expansion of its capacities last year. “Our goal is to ensure long-term supply for our customers in the future. With this in mind, we have invested approximately eleven million euros in the expansion of our facilities and locations,” explains Managing Director Ostrowicki.
For the third time in succession, BGS has secured its position among the best in the TOP 100 innovation challenge. In the scientific selection procedure, our company was able to convince the jury in the size class B (51 – 200 employees), especially in the categories “Innovation-friendly senior management” and “Outward looking/Open innovation”. Among other things, it was our high degree of flexibility in dealing with the corona crisis in the business segment radiation sterilization that was decisive; in the business segment of radiation crosslinking, we were able to score particularly well with our numerous development projects in the areas of 3D printing, lightweight construction and recycling.
In the independent selection procedure, the innovation researchers based their choice on 120 assessment criteria from five categories. “Repeat winners” must have demonstrably improved in the process. “We at BGS are expanding and we are pleased that our willingness to invest in the expansion at our locations as well as our continuous commitment to digital advancement were among the decisive factors taken into account in the assessment,” commented BGS Managing Director Dr. Andreas Ostrowicki on the award.
Business segment radiation sterilization: High degree of flexibility in the corona pandemic
Due to the current situation, this round also featured a special section examining the entrepreneurial response to the corona crisis. “Our service, radiation sterilization, plays a major role in modern health care. Our technology is indispensable in pandemic times since it is an important building block in the production of vaccines – for example, we sterilize the disposable bioreactors in which vaccines against Covid-19 are produced. In this respect, we swiftly created capacities and switched production so that corresponding products could be treated with priority,” Ostrowicki continues.
The corona crisis, in particular, has demanded special flexibility and solutions for existing processes from the medium-sized company, in part due to massive entry and exit restrictions. “When we recharged the sources for our gamma facilities in Wiehl and Bruchsal in March and October 2020, we were not able to fall back on our partners abroad,” explains Ostrowicki. Following intensive negotiations, we were able to win over a domestic partner and successfully solve the issue with the experts and our own employees.”
Business segment radiation crosslinking: Numerous development projects in progress
In the radiation crosslinking business segment, BGS was able to convince decisively with its ongoing research projects, above all in the area of 3D printing. For example, in a project with partners, BGS succeeded for the first time in using radiation crosslinking for 3D-printed plastic components, thus significantly improving the range of material properties.
In the future as well, it will be important to continue exploring the potential of radiation crosslinking. “Whether it involves weight reduction and lightweight construction, dealing with strong electrical currents, batteries or new production processes: The materials used are exposed to high temperatures and have to withstand extreme conditions. Radiation crosslinking can provide solutions for a wide range of applications now and in the future,” explains Ostrowicki. Sustainability is also on the agenda of the TOP 100 innovator. In this respect, BGS collaborates with the Technical University of Berlin, the University of Aalen and the partner nylon polymers on a process for the mechanical recycling of radiation crosslinked thermoplastics; the first results are expected in the course of this year.
About the TOP 100 competition
Since 1993, compamedia GmbH has awarded the TOP 100 seal of approval to small and medium-sized enterprises for outstanding innovative strength and above-average innovation achievements. Professor Dr. Nikolaus Franke has been scientific director since 2002. Dr. Franke is the founder and director of the Institute for Entrepreneurship and Innovation at the Vienna University of Economics and Business Administration. With 25 research awards and over 200 publications, he is one of the leading innovation researchers in the world. Mentor of TOP 100 is the science journalist Ranga Yogeshwar. Project partners are the Fraunhofer Society for the Promotion of Applied Research and the German Association for Small and Medium-sized Businesses (BVMW). Two business magazines, “manager magazine” and “impulse”, support the company comparison as media partners. More information and registration at www.top100.de.
According to the DIN EN 556-1 standard, a medical product is claimed sterile if the theoretical probability of finding a viable reproducible germon the product is less than 1:1,000,000. In order to achieve this state, products have to undergo a subsequent sterilization process. Different procedures and technologies are available to this end. Among the most common is sterilization using beta or electron and gamma rays, since this process offers a number of advantages. X-ray sterilization is in the early stages of development. In addition, chemical processes can be used for sterilizing, for example, exposure to ethylene oxide (EO or EtO) or to heat.
What are the similarities and differences between electron and gamma rays? What are the prerequisites for the use of radiation sterilisation and what are the main advantages of the procedure?
You can download the complete article here as a PDF file.
When it comes to social media communications, BGS is taking a new direction, and to this end, it is relying on the expertise of the Hamburg agency, Bamboo Consulting. Following a comprehensive agency screening process, the agency that specialises in B2B communications delivered a convincing tailor-made communications strategy for the social media channels of BGS.
“We have found a true expert in Bamboo Consulting for the communication of products and services requiring explanation in business-to business,” explained Dr. Andreas Ostrowicki, Managing Director of BGS. “The team has impressed us with its very sound knowledge and experience in the international technology sector and has presented a convincing social media concept. We are confident that with this, we shall strengthen our position in the market for irradiation services, while also optimally promoting the topics of our two business segments, namely radiation sterilization and radiation crosslinking.”
As of now, Bamboo Consulting will assume responsibility for the entire social media communications of BGS at European level – ranging from strategy development over continuous consulting and ongoing training to content development and marketing, as well as performance measurement.
Many medical devices need to be sterilized before they are launched on the market or allowed to be used on patients. One possible procedure here is sterilization with beta or gamma rays. How does this technology function exactly? Which are the differences between the two types of irradiation, and how long does it take to sterilize devices?
In order to answer these questions, a camera team from COMPAMED.de visited BGS headquarters in Wiehl and interviewed our expert on radiation sterilization, Dipl.-Ing. Annett Heilmann. More information in the short video report “Radiation sterilization: Sterile medical devices quick and safe”.
Headquarters Wiehl: BGS moves into new administration building
Following a two-year construction period, BGS moved into the new administration building at the headquarters in Wiehl in August 2020.
A modern office world spread over two floors, which facilitates communication and inter-departmental exchange: We are proud of our new working environment and look forward to welcoming our business partners, customers and suppliers in the new building with immediate effect.
All the familiar contact details of the contact partners in our company will remain the same. Likewise, the entrance to our company has not changed (GPS: 50.967050, 7.530913). The address of our administration will be the following from now on:
BGS Beta-Gamma-Service GmbH & Co. KG Fritz-Kotz-Straße 12 51674 Wiehl
We explicitly point out that the address of our business premises (Fritz-Kotz-Straße 16) has not changed and therefore all quality-related authorisations and documents will retain their validity!
For the second time in a row, BGS was named TOP 100 innovator in the TOP 100 innovation competition. In the scientific selection procedure, our company convinced the jury in the size class B (51 – 200 employees), especially in the category “Innovation to promote top management”. BGS whose technology is employed both in the sterilization of medical devices amongst other things, and in the refinement of plastics, is currently involved in numerous development projects in the areas of lightweight construction and recycling.
“The TOP 100 award is a great opportunity for us to further raise awareness for our technology,” explains BGS Managing Director Dr. Andreas Ostrowicki. Taking a look at the innovations of the future, he sees great potential in replacing metals by processed plastics, for example, in the engine compartment of motor vehicles or in fuel cells. “Numerous R&D projects are currently running in the area of radiation crosslinking. Whether it involves weight reduction and lightweight construction, dealing with strong electrical currents, batteries or new production processes: The materials used are exposed to high temperatures and have to withstand extreme conditions. Radiation crosslinking can provide solutions for numerous applications now and in the future.”
In addition, the TOP 100 innovator is increasingly underlining the topic of sustainability. In this respect, BGS is presently collaborating on a process with the Technical University of Berlin, the University of Aalen and the partner nylon polymers for mechanical recycling of radiation crosslinked thermoplastics; the first results are expected in 2021.
About the TOP 100 competition
Since 1993, compamedia GmbH has awarded the TOP 100 seal of approval to small and medium-sized enterprises for outstanding innovative strength and above-average innovation achievements. Professor Dr. Nikolaus Franke has been scientific director since 2002. Dr. Franke is the founder and director of the Institute for Entrepreneurship and Innovation at the Vienna University of Economics and Business Administration. Mentor of TOP 100 is the science journalist Ranga Yogeshwar. Project partners are the Fraunhofer Society for the Promotion of Applied Research and the German Association for Small and Medium-sized Businesses (BVMW). As media partners, manager magazin, impulse and W&V support the comparisons between the companies. More information at www.top100.de.
Our company is focused on the satisfaction of our customers and the high quality of our services. In order to fulfil this quality claim, we have our company monitored annually by the German Institute for Audits and Certifications of Management Systems (Deutsche Gesellschaft zur Zertifizierung von Managementsystemen [DQS Med GmbH]) within the context of the ISO 9001, ISO 13485 as well as the ISO 11137 certification.
This year’s re-certification audit in March 2020 was carried out at the three BGS locations in Wiehl, Bruchsal and Saal on a total of seven days. As in previous years, BGS fulfils all the requirements of the mentioned standards and was successfully certified pursuant to DIN EN ISO 9001, DIN EN ISO 13485 and DIN EN ISO 11137.
A summary of the certifications
DIN EN ISO 9001
DIN EN ISO 9001 is an international standard which attests a high quality claim towards customers and third parties.
The certification serves as a specifications catalogue for our quality management system.
By complying with and implementing the test criteria, BGS benefits from optimised in-house processes, conservation of resources and increased customer and employee satisfaction.
The goal of the standard is to understand and implement the demands placed on the company by interested parties.
DIN EN ISO 13485 and DIN EN ISO 11137
DIN EN ISO 13485 is an international standard for the quality management system of medical devices whose objective is patient safety. It contains detailed demands on topics such as the architecture, manufacture and placing of medical devices on the market, and it establishes the basis for cooperation between manufacturers and suppliers.
In addition, DIN EN ISO 11137 determines the requirements for the development, validation and routine control of the application of a radiation sterilization process for medical devices.
In implementing the changeover to the Medical Device Regulation (MDR), it is crucial in medical technology to have a critical supplier with certified quality management as this is relevant for registration. Both certifications furnish proof of the reliability and safety of the radiation sterilization service provided by BGS.
We are very pleased to report on the excellent results of the audit. In future, we shall have the processes and structures of our company examined in annual monitoring audits and certification measures with the aim of constantly improving our services. You will find further information on our certifications here.