DQS audit: Undergone successful re-certification

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DQS audit: Undergone successful re-certification

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.

High quality through certification

BGS: Your reliable partner in times of the corona pandemic

 

Dear business partners,

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.

Growth in the radiation sterilization business segment BGS records largest increase in turnover with biotechnological products

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.

In the BGS gamma systems, a wide variety of consumables for laboratory, biotechnology and medical technology are sterilized without residue.

Business segment radiation crosslinking: E-mobility and building sector ensure positive development

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 Beta Gamma Ueber uns - Bestrahlungsexperte
Pipe systems are irradiated using a special handling system at the BGS site in Bruchsal.

Everything at one location: BGS is centralising its order processing at the company’s headquarters in Wiehl.

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.

Compamed 2019: BGS is very satisfied with outcome of trade fair

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.

Sterilization of medical devices: Attention shifts to reducing failure risks

“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.

 

 

 

 

 

 

 

 

 

Professional article on the topic “Radiation crosslinking of films“ in the specialist magazine Kunststoffe international

Radiation crosslinking has long been used in the production of injection moulded parts. Radiation crosslinking of films, on the other hand, offers hitherto untapped potential for new appplications in the thermoforming of filled materials.

The following research results obtained at the Chair of Polymer Technology in Erlangen, Germany, together with BGS Beta-Gamma-Service, show among other things that the process window during thermoforming of filled films can be significantly widened by radiation crosslinking the semi-finished film articles.

You can download the complete article here as a PDF file.

(Kunststoffe international 10/2019, Authors: Lisa-Marie Wittmann, Dr. Dirk Fischer, Prof. Dr.-Ing Dietmar Drummer)

 

Compamed 2019: Radiation sterilization by BGS meets cutting edge medical technology

When it comes to sterile products for highly sensitive working areas, BGS is indispensable. Therefore, Germany’s leading provider in the industrial sterilization of medical products and lab diagnostics amongst other things is, with the help of its beta and gamma rays, once again firmly established at the Compamed in Düsseldorf. From November 18 – 21, 2019, BGS will provide information in Hall 08B, Stand 8BK16 about the capacity expansion that is being realised in Bruchsal with the reconstruction of the gamma facility; it will also provide advice to manufacturers of medical products concerning validation issues.

“In view of the medical-technical progress and the demographic development in the next years, the medical technology sector is and will remain an extremely successful growth and labour market,” comments Dr. Andreas Ostrowicki. “Without doubt, the demand for health care services and thus for medical products will continue to increase worldwide. According to estimates of the Federal Ministry of Health, there are already approximately 400,000 different medical products at present. Needless to say, the corresponding sterilization capacities have to keep up with this strong growth. BGS already invested in the expansion of facilities at a very early stage and is optimally equipped to support the market growth of the next years,”Ostrowicki continues to explain.

With the commissioning of the new gamma radiation facility, the company was already able to expand capacities for its customers to 80,000 palettes of sterile goods per year. In total, BGS operates two gamma plants and eight electron accelerators at three locations in Germany (Wiehl, Bruchsal, Saal). In these plants, medical products such as syringes, cannulas, catheters, and joint prostheses can be directly sterilized in the packaging within the shortest time and are ready for immediate use afterwards.

Based on the projected increase of sterile medical products, the topics of double qualification and back-up solutions for manufacturers of medical products will become even more significant in the future according to managing director 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. We, at BGS, have been following up on the “principle of redundancy” for years. For example, each of our three locations is in a position to assume the processes of the other locations, by means of which the failure safety in production can be significantly increased,” explains Dr. Andreas Ostrowicki. Given this fact, the company once again regards itself as a solution provider at the Compamed this year and is available to answer the questions of manufacturers amongst others, giving them advice about issues relating to validation.

About the Compamed:

The Compamed trade fair in Düsseldorf is the international specialist trade fair for the medical supply industry and product development. In two trade fair halls with exhibition space of over 13,000 sqm, more than 750 exhibitors from 40 countries are expected to participate in 2019. Amongst the focus areas at the trade fair are high-tech solutions, raw materials and precursors, structural elements, components and sub-products for medical devices, technical equipment and technologies for producing medical devices, packaging and services, micro systematics, and nanotechnology as well as contract manufacturing “Electronic Manufacturing Services” (EMS), and complex OEM partnerships. In addition, international speakers and leading experts will participate in forums that present current trends in medical technology. The Compamed takes place at the same time as the Medica – the world’s largest medical trade fair. More information about the Compamed is available at https://www.compamed-tradefair.com/.

 

 

 

 

 

K Trade Fair 2019: BGS provides information about new applications for radiation crosslinked plastics at the world’s largest trade fair for plastics and rubber

The developments in the mobility sector are increasingly placing more complex demands on plastics: The shift towards electrical drive technologies results in the fact that plastics, in addition to their good electrical properties, high non-inflammability and higher continuous operating temperatures, must also have a high chemical resistance against electrolytes and coolants. Moreover, there are high mechanical requirements for strengths, stiffnesses and abrasion due to the necessity for weight reduction. Crosslinking of technical thermoplastics through electron beams provides an alternative to the use of metallic materials and costly high-performance plastics. BGS experts will explain the role of radiation crosslinked plastics for future mobility concepts in Hall 8A / D47 at the K Trade Fair in Düsseldorf from October 16 – October 23, 2019.

“This year, we are not only providing information about radiation crosslinking in general and thus the refinement of various types of plastics using beta and gamma rays”, explains Dr. Andreas Ostrowicki, Managing Director of BGS.  “The focus is primarily on the potential that our technology brings about for electro mobility and light construction. Here, amongst other things, we see the potential in the field of energy distribution, storage or production of energy in batteries or fuel cells, but also for the use of thermoplastic composite materials and/or organic sheets in light construction.

Through radiation crosslinking, technical plastics receive the mechanical, thermal and chemical properties of high-performance plastics. After that, the products prove themselves for use under conditions which they would normally not withstand otherwise. Among the customers of the radiation expert that has been active since 1981 are well-known manufacturers from the electrical technology, automotive industry as well as building technology and mechanical engineering sectors.

Meet BGS at the K 2019! Via this link to our trade fair calendar, you can arrange your desired time slot with one of our radiation crosslinking experts.

About the K Trade Fair

The K is the world’s largest trade fair for the plastics and rubber industry, gathering the most important providers of plastics and rubber machines, raw materials and auxiliaries as well as semi-finished products, technical parts and reinforced plastic products in one place. The K is complemented by the special show “Plastics Shape the Future”, where current topics are discussed such as packaging waste and climate change on one hand as well as preservation of natural resources, energy efficiency and recycling management on the other hand. On the eight days of the trade fair, 3,000 exhibitors and more than 200,000 visitors from all over the world are expected to attend. More information about the K can be found at www.k-online.de.

Excellent innovative strength and innovative achievements: BGS is TOP 100 Innovator

In the 26th edition of the innovation competition TOP 100, BGS Beta-Gamma-Service GmbH & Co. KG has secured its position among the best:  At the awards ceremony held on June 28 in the Frankfurt Jahrhunderthalle, the company was officially honoured for its innovative strength by Ranga Yogeshwar, the mentor of the competition, and Professor Dr. Nikolaus Franke, the scientific leader of the contest. On the basis of a scientific classification, TOP 100 assesses the innovation management of small and medium-sized enterprises and the innovative accomplishments that emerge from this. In the independent selection process, BGS convinced the jury especially in the category “innovative measures to support top management” as well as with its external orientation.The company with currently 180 employees fits smoothly into the ranks of the innovation leaders of Germany’s small and medium-sized enterprises.

“We are very pleased about the award and consider it a confirmation of our work”, comments Dr. Andreas Ostrowicki, Managing Director of BGS. “At our company, innovative strength is not only reflected in our open-mindedness towards innovative ideas, but in particular, in the ongoing development of solution ideas for our customers and the continuous research of new application areas for our services.” 

In addition to the sterilization of medical devices amongst other things, the Top Innovator, founded in Wiehl near Cologne in 1981, has specialised in the processing of plastics for electrical technology, the automotive industry and mechanical engineering. Radiation crosslinking makes inexpensive commodity plastics more robust, heat-proof and resistant against abrasion and corrosive chemicals – the process is comparable to the tempering of metals. In this way, metallic materials can be replaced by plastics without using expensive high-performance plastics – a technology where Dr. Ostrowicki sees great potential in lightweight construction, for example in the automotive industry. Meanwhile, the company operates two gamma radiation plants and eight electron accelerators at its locations in Wiehl, Bruchsal and Saal a. d. Donau, and is Germany’s leading service provider for the treatment of products with accelerated electrons (beta rays) and gamma rays.

About the TOP 100 Competition

Since 1993, compamedia GmbH has awarded the TOP 100 seal of approval for outstanding innovative strength and above-average innovation achievements to small and medium-sized enterprises. Professor Dr. Nikolaus Franke has been head of the scientific management 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.

BGS Managing Director Dr. Andreas Ostrowicki (left) and Stefan Semmel, Director of Processes and Technology (right) with TOP 100-Mentor Ranga Yogeshwar. © KD Busch / compamedia