A cleanroom almost like paradise

Fig. 1: New building with manufacturing and technical center (© Becker)

Fig 2: View into the front area of the GMP class "C" (© Becker)

Fig. 3: Sterile production GMP Class "A" in B" for cytostatics, BECKER Quickout pass-through on the right in the image (© Becker)

Fig. 4: Loading side of the Quick-Out lock in the "B" area (© Becker)

Fig. 5: Discharge side of the Quick-Out lock in the "CNC" area (© Becker)

Fig 6: View into the technical control room: from here, all cleanrooms are supplied energy-efficiently (© Becker)

"Not exactly in paradise, but in the 'Pharmacy at the Monastery of Paradise,' we were allowed to build a new cleanroom for sterile manufacturing," says Dirk Steil, Managing Director of BECKER Cleanroom Technology, proudly referring to the project recently put into operation near Soest.

The Pharmacy at the Monastery of Paradise is located on the grounds of the former Dominican Monastery in Soest-Paradise. It belongs to COMBIMED, the umbrella brand group of A&D Apotheken OHG, owned by pharmacist Hubertus Ahaus. A team of specially trained specialists ensures high quality in the in-house production of sterile preparations according to GMP standards, such as cytostatics, parenteral nutrition solutions, specialized pain therapies, and intravenous antibiotic therapies.

BECKER Cleanroom Technology received the order as early as 2019 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 demand to work together with the client to find an optimum for process workflows and logistics, ensuring that manufacturing remains efficient and cost-effective over many years in the future. The focus of BECKER technicians was also on the energy efficiency of the entire systems to minimize ongoing costs. Thus, a "custom-fit" was created for the client's cleanroom production. Last but not least, the client was supported throughout the entire process, including overcoming formal hurdles and obtaining official approval.

The core of the manufacturing process includes three GMP class "B" production rooms, where up to nine workstations operate in sterile and safety cabinets of GMP class "A." The areas are separated into TOX and NONTOX to ensure product protection as well as personnel safety and to prevent cross-contamination. The total area of the classified core cleanrooms exceeds 200 m². Additional logistics areas are located adjacent to the cleanrooms.

To minimize manufacturing costs, it is essential to implement a highly efficient material flow that saves time and money. Investments in smart technology are amortized in the shortest possible time. A significant highlight is the patented and TÜV-certified Quick-Out shuttle by BECKER Cleanroom Technology: it allows goods to be discharged across multiple cleanroom classes immediately after production, without the risk of recontamination. This is a real benefit for Combimed and generally for all customers who want to manufacture cost-effectively.

Operational safety of the systems is of fundamental importance in manufacturing. After all, ad hoc preparations often involve life-and-death situations. To ensure this, specially developed and built ventilation devices guarantee continued operation of all areas in case of a component failure, without incurring double investment costs.

In addition to the initial investment costs for a cleanroom, the ongoing costs of these systems are also crucial and are often overlooked in investment decisions. In this flagship project, they were a top priority from the start: the technical control center was placed directly above the cleanrooms, making the routes for energy-intensive air transport particularly short. This saves electricity 365 days a year. An equally effective way to save energy is through intelligent control of the down-time operation: individual areas can be lowered independently and re-validated before being brought back online.

The BECKER concept also considered the staff: the cleanrooms have a high degree of transparency among each other, creating safety and a sense of well-being — especially when one can look directly from the cleanrooms out into the greenery of the Paradise courtyard.