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!
Lightweight materials can be a central component in climate-neutral production. Plastics are often effective in this context. However, depending on the application, they have to stand up to high temperatures and extreme conditions. Radiation crosslinking of thermoplastics offers new potential for lightweight construction as conventional plastics can also be qualified for demanding tasks with this refining process.
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.
The corona pandemic is a new challenge for all of us, in particular for the global healthcare sector. Numerous customers of ours from the areas of medicine technology, biotechnology, pharmaceutics, and research – and thus BGS as a partner and provider of sterilization services – have a special responsibility during these times: Our joint task is to provide supplies.
We would like to assure you as customers and business partners: At BGS, we are doing everything to make sure your orders are processed as quickly as possible and in the usual high quality. To this end, we have expanded our production capacities in the last weeks by reloading cobalt-60 at our gamma facility in Wiehl, we have established additional shifts, and increased among other things, the utilization for irradiation of medical consumables and in-vitro diagnostics by 25 to 30%.
Based on recommendations of the RKI (Robert Koch Institute) and the respective recommendations of operative pandemic planning, we have taken extensive preventative measures concerning the coronavirus. Our priorities are to protect our employees against an infection and to reduce the risk of an interruption of operations to a minimum. At the moment, the measures we are taking put us in a position to act and deliver to the fullest extent. We continue to observe the situation closely and will adjust our measures at short notice if need be.
Your contact person and our staff members from customer service are at your disposal and will be happy to answer any further queries.
Let us work together to deal with this exceptional situation in the best way possible – we are grateful for the trust you have placed in us.
The market for medical biotechnology in Germany is growing – and with it, the need for sterilization services. In 2019, for example, BGS recorded an increase in turnover of around 30 percent with products from the biotechnology area. Bioreactors and culture media used in microbiological testing are some of the most frequently treated items.
In the business segment of radiation sterilization, BGS saw further significant increases in 2019 of approximately 24 percent for products from the areas of pharmaceutical primary packaging material and medical devices. The increases are attributed to the excellent situation in the medical technology market and the increased demand for gamma and beta sterilization as the preferred sterilization method of many manufacturers.
Business year 2020: Setting the course for market growth
The increases in the business segment of radiation sterilization provide for a steadily increasing capacity utilization of both gamma facilities at the locations in Wiehl and Bruchsal. “The positive development encourages us to pursue the path we have embarked on and shows that our investments of the last years have paid off,” comments Dr. Andreas Ostrowicki, Managing Director of BGS. The company commissioned a second gamma facility in 2018, and with the introduction of a modern ERP system, optimised numerous business processes and further improved the service quality. In order to ensure long-term customer support and promote market growth, BGS is investing 7 million euros in the current business year for the expansion of its capacity. The productive capacity of both gamma facilities will be increased, for example, through reloads using cobalt-60. In addition, a new logistics hall is being built in Bruchsal that will offer about 2,700 square metres of extra warehouse space by the end of 2020.
With the help of gamma and beta rays, BGS refined about 10 percent more injection-moulded components in 2019 than in the same period last year. The increase in turnover is attributed to the increased demand in the automotive industry. This branch has a growing need for lightweight materials as steadily increasing demands are placed on the thermal, mechanical and chemical resilience of components. Furthermore, BGS recorded ongoing good growth with the crosslinking of piping and rod products used in district heating and cooling technology of urban infrastructure projects.
Automotive industry shows strong interest in radiation crosslinking
Numerous components manufactured from radiation crosslinked plastics are already being used in the engine compartment, for coverings, fastening elements, as well as for components in the interior and exterior area. “We recorded increased demand from automotive suppliers in 2019 and more projects in the area of injection moulding,” explained Dr. Andreas Ostrowicki, Managing Director of BGS. Radiation crosslinking offers new possibilities, especially for lightweight construction, as conventional plastics can also be qualified for demanding tasks using this refining technique. Crosslinked components show significantly improved properties in terms of heat and abrasion resistance, mechanical stability and creep behaviour. Ostrowicki also believes radiation crosslinking is becoming more interesting for the automotive industry in view of growing cost pressure: “Depending on the amount of the procurement costs for high-performance plastic, substituting it with a crosslinked material can lead to substantial direct savings. Other factors include reduced process costs, since radiation crosslinked compounds distinguish themselves through easy processing (e.g. low processing temperatures compared to high-performance plastics).”
Building sector also provides for increased turnover in area of radiation crosslinking
BGS registered a further increase of piping and rod products (around 10 percent) in 2019 over the previous year. The increases in this segment can be ascribed to a continuing good economy in the building sector – in particular, district heating and cooling systems of urban infrastructure projects process crosslinked piping. Radiation crosslinking ensures the performance characteristics of piping systems over a long period: It provides for improved creep behaviour at high temperatures and internal pressure, and consequently higher aging resistance. A major part of the piping systems is irradiated in Bruchsal with the help of a special handling system that tolerates dimensions of up to 12 metres for pipes and rods.
Business years 2020 and 2021: Modernisation and expansion at locations
After extensively modernising the electron accelerators at company headquarters in Wiehl, BGS is also investing millions of euros in the modernisation of the facilities and handling technology at the locations in Bruchsal and Saal a.d. Donau. Planning is underway in Bruchsal for the construction of a new logistics hall: A total of 2,700 square metres of new warehouse space will be created here by the end of 2020.
BGS has been a leading service provider in the area of industrial applications of beta and gamma rays for many years and it continues its steady expansion course. This also means that processes are regularly reviewed and continually optimised – especially for our customers. Apart from reliability and flexibility in the processing of orders, it is important to have constant contact persons – across all our locations.
As a result, BGS is further consolidating its administrative order processing. At our plant in Bruchsal, we have already completed this step successfully starting 1 November 2018. We are now taking the next step and shifting the administrative processing of orders from our location in Saal a.d. Donau to our headquarters in Wiehl.
The centralisation will take place on 1 April 2020. The processing of all customer orders, coordination of dates, invoicing, as well as customer service will be exclusively controlled from the company’s headquarters as of this date, irrespective of the location where the goods are irradiated.
We have informed our customers by post in calendar week 7 about the centralisation of the order processing. We are happy to answer any questions about the changeover under +49 (0)2261 7899-0.
Wiehl, 22 November 2019 – Compamed is over and Dr. Andreas Ostrowicki, Managing Director of BGS, sums up the trade fair positively. On one hand, the company was able to welcome more visitors to the BGS stand than in previous years. On the other hand, there was increasing interest in alternative sterilization methods and advice regarding second-source solutions following the ongoing critical coverage on ETO sterilization and facility shutdowns in the US market. Under the motto “Energy that changes everything”, BGS actively contributed to creating awareness for themes like validation and process integration of radiation sterilization, as well as giving advice on the related regulatory requirements.
“As leading provider of sterilization services and solutions in the area of industrial application of beta and gamma rays, Compamed is a fixed date each year for BGS,” comments Dr. Andreas Ostrowicki. “The trade fair has high priority for us as a platform to exchange views and ideas with industry representatives and business partners. Despite sustained growth in the industry, the mood among medical technology companies was slightly subdued. One of the main reasons for this is the transition period of the EU Medical Device Regulation which will soon be expiring, combined with the ensuing uncertainty of marketing medical devices.” Many manufacturers fear they will not be able to place their devices on the market in a timely manner due to longer evaluation procedures. Central themes of concern in the industry were also the question of ensuring the necessary sterilization capacities commensurate with market growth, as well as establishing second sources for sterilization.
“The talks at the trade fair showed that the demand for double qualifications and back-up solutions for manufacturers of medical devices is becoming increasing relevant,” explained Ostrowicki. “In the context of risk assessment, every manufacturer should ask himself what would happen if there was a shutdown in the plant commissioned with the sterilization services. The most recent cases in the US show that longer shutdowns not only result in severe financial losses, but may in certain circumstances also lead to considerable supply gaps on the market; creating a second source is therefore absolutely advisable. Here, it was necessary to examine in each case whether the device in question at the existing service provider could be qualified for a second facility, whether contracts should be concluded with an additional provider, or whether a qualification for another method of sterilization was the best prevention to forestall failure risks. BGS has been following the principle of ‘redundancy’ for years now. This means that each of the three locations of the company is able to take over the processes of the other locations, thus increasing the reliability in the production.
You will find further information about radiation sterilization of medical devices and consumables for laboratories and biotechnology, amongst other things, here.