Transparent Quality

B. Braun is one of the leading providers worldwide of solutions for the healthcare market and supplies users and patients with products and product systems for anesthesia, intensive care, cardiology, extracorporeal blood treatment, or surgery, as well as services for hospitals, outpatient doctors, and the homecare sector.

In constructive exchange with customers and partners, B. Braun develops effective solutions for the healthcare market as a "system partner in healthcare" that protect and improve people's lives around the world. For B. Braun, this means "Sharing Expertise".

With competence and "Sharing Expertise" to success

The new construction of B. Braun's subsidiary PNS (Professional Nutrition Services GmbH) is an example of how "Sharing Expertise" has not only been practiced with customers and partners but also influenced the development process of the new production facility at the company's site in Melsungen.

Since 2003, B. Braun has operated a "Compounding Service" with PNS, which supplements the company's product portfolio with individually prepared parenteral nutrition. After more than ten years of continuous production at the old site, an upgrade to the current state of technology, as well as further development and optimization of production processes, became necessary.

Compounding is for critically ill, malnourished patients with specific nutritional needs (e.g., liver or kidney failure) who require tailored dosing of macronutrients and electrolytes. An aseptic manufacturing process for these medicines requires a cleanroom system according to EU-GMP standards. Production is carried out according to strict GMP guidelines (Good Manufacturing Practice) and with maximum requirements for cleanroom conditions (Class A cleanroom), ensuring safe patient care. With the construction of a new building for patient-specific nutrition solutions, a production facility was created in close collaboration with construction and project partners that meets the latest technical standards and the highest quality standards. This applies not only to the production equipment but also to building design and materials.

Corporate design in all areas

From the beginning of planning, dialogue with international B. Braun colleagues in Great Britain, Ireland, Italy, Poland, Spain, and the USA influenced the construction concept. Ideas, suggestions, and experiences from already completed compounding production facilities are exchanged, and "Sharing Expertise," the company's guiding principle, is lived in practice.

The new compounding factory is characterized by clear architecture, an optimized production process, and modular expandability. The building adopts the company's design language and follows the prescribed architectural patterns. It has the recognition value as a B. Braun plant. What has already been built in the "large" LIFE plants is reflected here on a smaller scale: the same colors and materials, the same transparency concept, the same material quality. The entire building is planned as a simple cube with plenty of light and open design.

The new production site serves as a case study for other locations with similar cleanroom concepts. The Melsungen construction demonstrates that the transfer of the concept in terms of transparency, modularity, quality, and sustainability is successful.

The modularity facilitates the reproducibility of the system; an expansion or extension of the production facility is thus possible without interrupting ongoing operations. The building geometry and equipment are designed so that realization is also economically feasible in other countries.

Without disturbing operations, customers and interested parties can gain direct insight into production through a glass visitor walkway, follow each manufacturing step, and be convinced of the high standards of production. The visitor area exemplifies the transparent design of PNS.

In the cleanroom, transparency and quality are indispensable

The heart of the PNS production facility is the production room, where the requirements for cleanliness, transparency, quality, and reliability are highest. The desire for transparency is achieved at PNS through a maximum glass content in interior design. In production, visual contact between employees is a prerequisite for smooth communication and a high safety standard. Thus, there is a clear line of sight from the pre-disinfection area through the production room to the finished product inspection.

The production room must ensure germ-free conditions for manufacturing. The interior design of the production facility is therefore based on a "onion skin" principle and divided into different areas. In the "black" area, which is less controlled, are the office rooms, material storage, restrooms, technical areas, and visitor walkway. The "white" area includes the production and quality control sections, with further cleanliness levels from GMP Class D to Class A within the "white" zone. This division allows strict separation of work areas and prevents the spread of germs and contamination. The cleanroom zones are only accessible via personnel and material sluices.

For the production room, with a volume of 200 cubic meters on a 63-square-meter footprint, a specially developed ventilation technology was designed and installed to ensure ideal air distribution. The hygiene zone and pressure differential concept are prerequisites for successful and hygienic work. The technology must permanently maintain the required room pressure differences between rooms of different cleanliness classes. The cleanest room has the highest air pressure and must be supplied with nearly germ- and dust-free air. The design of a high-performance cleanroom monitoring system (RRMS) in collaboration with an external company ensures that all relevant parameters, such as airborne particles, room pressure, and temperature, are continuously measured and ultimately maintained.

Quality furniture with antibacterial coating

Cleanrooms are characterized by cleanliness, openness, and functionality. These properties are also reflected in PNS in the specially manufactured furniture in the production area. Besides being functional, the furniture must withstand years of intensive contact with cleaning and disinfecting agents and meet strict pharmaceutical GMP requirements. These requirements are best fulfilled with materials such as HPL compact panels with antibacterial coatings. The processing of this material requires a high level of technical expertise and solutions that harmonize design and function. B. Braun relies on a long-standing regional partner for this.

A seamless process – from order to patient

The production process of a nutritional solution begins with an individual prescription for a patient, which the pharmacy forwards to PNS. After verifying the formulation, production starts with assembling the starting products, mostly sourced from B. Braun's own manufacturing. The starting products are transferred from storage via a material sluice into pre-disinfection, then into disinfection, and finally through a specially developed, particularly wide pass-through sluice into the GMP Class B production room. Staff access the production room via a multi-stage sluice. Inside, computer-controlled filling machines are located at the clean workbenches. The disinfected starting products are connected to the machines and filled into sterile bags according to the prescription. The bags are then hermetically sealed and ejected through a second material pass-through from the production room. Each finished bag is inspected, labeled, and sealed in a foil bag. Systematic quality checks verify correct dosing and sterility. Finally, the nutritional solution is stored overnight in the cooling sluice. The next day, the compounded product is shipped via express delivery in specially tested cool boxes to the pharmacy.

Quality and safety are top priorities

There are no compromises in pharmaceutical manufacturing. Together with partner companies, B. Braun has created an innovative site that combines quality, safety, and transparency. PNS stands for the highest technical standards and customized services with high-quality products. The new facility is therefore not only a successful investment in the region but also in the future of patient-specific medical care.