New head of quality assurance at BGS Beta-Gamma-Service

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.

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Location in Bruchsal: 2,700 square metres of new logistics space for sterile products

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.”