No off-the-shelf cleanroom

Fig. 3: View into one of the manufacturing rooms for cytostatics

Fig 4: Sterile production for parenteral nutrition,

Fig. 5: patented BECKER QuickOut lock: loading side in GMP "B" area (shown on the right in the picture)

Fig. 6: Discharge side of the Quick-Out lock in the "CNC" area

Fig. 7: Cleanroom elevator from the logistics area "CNC" to the preparation class "C"

Fig 8: Photo motifs in the cleanroom walls create a sense of well-being among employees

Fig. 1+2: New construction project "GS28" at Gebhardtstraße 28 in Fürth

Figures 1+2: New construction project "GS28" at Gebhardtstraße 28 in Fürth

"We accepted the challenge and explored many new paths. The result is cleanrooms of the highest class!" says Dirk Steil, Managing Director of BECKER Cleanroom Technology, proudly referring to the project recently commissioned at ABF in Fürth.

ABF is a family-run company that, in addition to traditional pharmacy operations, specializes in highly specialized, patient-specific solutions for selected pharmaceutical issues. The company, with over 40 years of experience, currently employs more than 250 staff members.

The ABF cleanroom laboratory focuses on preparing individual, patient-specific formulations in outpatient therapy, such as cytostatic supply, parenteral nutrition, pain therapy, antibiotic therapy, Desferal therapy, and antiviral therapy.

To adequately accommodate the growing demand, a new building has now been commissioned. The "GS28," a modern building at Gebhardstraße 28 in Fürth, offers innovative companies a representative home for creative work. The detailed architecture and the perfectly coordinated interior design, down to the smallest detail, create extraordinary accents.

But not only the interior design is extraordinary. The building also features state-of-the-art cleanrooms.

BECKER Cleanroom Technology received the order in 2017 for comprehensive planning and turnkey construction of all GMP cleanrooms. The starting point was the famous "green meadow." The challenge was to consider, coordinate, and find solutions for numerous interfaces with the architecture of the new building. On the other hand, there was a particular goal to work together with the client to find an optimum for process workflows and logistics, ensuring that production remains efficient and cost-effective over many years. The focus of BECKER technicians was also on the energy efficiency of the entire system to minimize ongoing costs. Thus, a "custom-made" solution was created for the client's cleanroom production.

The core of the manufacturing includes three GMP class "B" production rooms, where nine workstations operate in sterile and safety cabinets of GMP class "A." The areas are separated into TOX and NONTOX zones to ensure product protection as well as personnel safety and to prevent cross-contamination. The total area of the core cleanrooms exceeds 400 m².

In addition to the cleanrooms, laboratory rooms, cooling cells, server room cooling, storage cooling, and office cooling were also supplied — no problem for the Saarland-based company, as BECKER Group has nearly 95 years of experience in climate, ventilation, and refrigeration technology. "For many customers, our climate/ventilation expertise is also very valuable outside of cleanroom technology because we can provide a tailored overall concept and deliver everything from a single source," says Steil.

Back to the highlights of the cleanroom technology: what sets this project apart from "off-the-shelf" cleanrooms, which are often equipped with aluminum profile systems simply fitted with FFUs to offer the lowest possible price? The answer: many things, if not everything!

To minimize manufacturing costs, it is essential to implement a highly efficient material flow that saves time and costs. Investments in smart technology are quickly amortized here. One first highlight is the patented and TÜV-certified Quick-Out isolator by BECKER: it allows goods to be discharged across multiple cleanroom classes in a short distance after manufacturing, without the risk of recontamination. A real benefit for ABF and generally for all customers who want to produce cost-effectively.

Cost savings can be achieved not only through rapid horizontal material flow but also vertically. In ABF's new building, the cleanrooms and logistics areas span several floors — short distances save money, but as always in cleanroom technology: safety is paramount, and contamination must be avoided. For this purpose, a cleanroom elevator was planned and installed in Fürth, which can deliver directly from the logistics zone on the ground floor of class "CNC" to the GMP class "C" preparation area in a validated process. Faster and safer is not possible.

Operational safety of the systems is of fundamental importance in manufacturing. After all, ad hoc productions often involve human lives. To ensure this, specially developed combinations of ventilation devices were built that ensure continued operation of all areas in case of a component failure, without incurring double investment costs. There are also emergency switching scenarios for cooling with special hydraulic circuits and setpoint shifts. The same applies to the heating medium, which has an emergency pressure hold in case of failure. Even particle monitoring is redundantly implemented. To complete the safety measures, emergency switches are installed in critical manufacturing areas, which activate the appropriate ventilation steps in an emergency.

In addition to the investment costs for a cleanroom, the ongoing costs of these systems are also of fundamental importance and are often still neglected in investment decisions. In this flagship project, they were a top priority from the start: cooling is provided through free cooling via heat exchangers and plate heat exchangers, which is the most efficient cooling method given the external conditions. Another highly effective energy-saving measure is intelligent control of setback operation: individual rooms and areas can be lowered and re-energized in a validated manner, independently of each other and across multiple floors.

In a comprehensive concept of this quality level, ergonomic and comfort factors for employees were also considered. Alarm messages are not sent via horns and flashing lights as usual, but manufacturing staff receive alarm messages directly on a display at the workstation, in plain text, allowing individual responses without disturbing the manufacturing process at the bench.

Inside the safety cabinets, cameras are installed to secure and optimize the manufacturing process and to be used for training purposes.

Under the motto "The eye produces with...", a comfort factor for the employees' eyes was created in the cleanrooms: selected areas of the rooms feature GMP-compliant photographic motifs integrated into the cleanroom walls.