Quality, safety and reliability

In an increasingly expanding market, pharmaceutical companies are coming to rely on contract services providers, such as B. Braun, which offer expertise, products and services.

In the global economy, extended supply chains mean that firms no longer have to manufacture every component of the products that they supply. Instead, they can access the expertise of specialist companies to source goods and services, often at less cost and with better quality. ‘This is particularly useful in the healthcare sector where quality, safety and reliability are paramount,’ says Dr Thilo Brinkmann, vice-president of OEM Europe and Asia Pacific at healthcare firm B. Braun.

Healthcare specialist
B. Braun is one of the industry’s leading healthcare companies. With over 170 years’ experience, B. Braun supplies products and services to the specific areas of medicine: hospitals, surgery, private practices and extracorporal blood treatment. Through its OEM Division, it allows industrial customers to access this concentrated expertise. The OEM business specialises in three main areas:

• pharmaceutical solutions, particularly infusion solutions, injectables and irrigation solutions
• medical devices, notably syringes and needles, infusion and irrigation systems, venipuncture and infusion pumps
• products for disinfection and hygiene.

‘We offer B. Braun’s products, capabilities and services to industrial customers so that anybody can take advantage of the experience we have in the field of infusion technology, either from the pharmacological side or from the medical devices/technical side,’ says Brinkmann. ‘They get products, expertise and additional services such as registration support, codevelopment, adjustments or specific customised changes in our product range as well as private label. The customer can use us as a workbench or as a contract manufacturer.’

The two main areas that the OEM business is involved in are contract manufacturing of infusion and injection solutions, and supplying secondary packaging material: everything that is needed to infuse or inject drugs, including products for drug withdrawal and admixture, infusion and transfusion accessories, IV administration and access, covering a portfolio of over 30,000 items.

Essential standards
B. Braun places a strong emphasis on quality, safety and reliability, an essential factor for industrial clients. ‘Our quality standards meet all the necessary industry standards, and we try to exceed them whenever we can,’ says Brinkmann. ‘We have a sustainable approach to quality, meeting US FDA requirements wherever possible. Our team is experienced and has successfully dealt with many customer audits. We even have medical and pharmacological compound production experience for the Japanese market, one of the most demanding in the world.’

Quality makes a big difference even down to the smallest detail. ‘For a high value and safe drug application, it is important to have a good quality medical device,’ says Brinkmann. ‘A pharmaceutical company with a high value drug needs adequate application devices to guarantee constant quality, safety and reliability.’

Safety for B. Braun means not only ensuring safety through higher production quality, but also continuously innovating and improving products regarding the safety aspect, focusing on patients as well as healthcare personnel. For example, the firm’s latest IV catheter, the Vasofix Safety, incorporates a self-activating mechanism that automatically covers the tip of the steel cannula used to pierce the vein when the catheter is used. While this may seem like a small innovation, in Germany alone the associated costs to ensure those people who have needlestick injuries are tested for infection can reach over €10 million, covering 500,000 professional incidents a year. ‘That is just those that are documented; many more go unreported,’ explains Brinkmann. ‘It does not cover the ongoing costs and personal distress for those people where a problem is picked up on testing.’

The firm’s relentless focus on quality, safety and reliability is one of the reasons that, whether it is assisting with product variation and combination, common development, contract manufacturing, logistics, packaging, sterilisation, private labelling or quality control, B. Braun OEM is the partner of choice for the healthcare sector.