Reinstes Do-it-yourself

Figure 1 Weiss Pharmatechnik: WIBOjekt laboratory workstation in GMP design, Type TGRJO 120/64.

Figure 2 Weiss Klimatechnik: The new cleanroom for CuraFaktur.

Figure 3 Weiss Pharmatechnik: Product protection workbench, Type KVF, according to EN ISO 14644-1, customized, mobile version with electric front panel, double workstation open at the back, here for sterilization filtrations under ISO Class 5.

Figure 4 Weiss Klimatechnik: The climate control center with Weiss recirculating air climate compact units, a central outdoor air treatment system, and a separate humidification system.

Weiss Climate Technology designed, planned, and turnkey constructed a state-of-the-art cleanroom with air handling systems for the laboratory service provider CuraFaktur in Heilbronn. The subsidiary Weiss Pharmatechnik supplied the appropriate safety cabinets and workbenches. The CuraFaktur laboratory is available to doctors and authorized persons for the non-permitted self-production of medicines.

Many people associate homemade products with quince jam or crookedly assembled bookshelves, less often with the professional production of modern medicines: medicine usually comes in colorful boxes from the pharmacy. However, many doctors have far-reaching demands — the offerings of pharmaceutical manufacturers are not sufficient for them, so they often produce certain medications themselves. The reasons are varied: the doctor may find the quality available on the market insufficient, or they may not get the desired concentrations and combinations — or the doctor wants to develop and produce a patient-specific medicine.

In many cases, this requires a modern and well-equipped cleanroom laboratory. Only here are doctors and authorized persons allowed to produce medicines under their direct professional responsibility, because German pharmaceutical law does not see much value in mixing healing potions in the tea kitchen.

Quick success as a start-up

This need inspired the founders of CuraFaktur in Heilbronn: not every doctor has access to a cleanroom laboratory with the necessary equipment to produce individual medicines for personalized therapy concepts. Dr. sc. hum. Rebekka Zirbel and Dr. biol. hum. Thomas Fink founded CuraFaktur in Heilbronn a few years ago. It provides doctors with laboratory capacities at a high level — with state-of-the-art equipment. Additionally, they offer a qualification and training program to acquire and deepen the expertise required for non-permitted self-production of medicines.

New building with rental concept

The idea proved to be extremely successful — by July 2016, CuraFaktur celebrated its five-year anniversary. After just two years, due to high demand, the premises had to be expanded — the company moved into new spaces in the Heilbronn industrial area. Here, CuraFaktur operates with a model as innovative as the founding idea itself: the new building was specially constructed for CuraFaktur by the local developer Stadtsiedlung and leased to the company — a unique model in this form.

Weiss Climate Technology, as general contractor, initially designed the layout of the new building structurally to precisely match the company's processes, as Karl-Heinz Lotz, Head of the Strategic Business Area Cleanroom at Weiss Climate Technology, explains. "When designing the cleanroom laboratory for CuraFaktur, we faced processes that deviated significantly from the usual. The cleanrooms, which are rented out to CuraFaktur clients, required a complex, tailored structure," says Karl-Heinz Lotz. Together with Stadtsiedlung, the building was then planned around this layout concept.

The result is two floors — with administrative rooms on the ground floor and technical rooms with the cleanroom on the upper floor: here, there is a generous 270 m² of classified cleanroom space and 140 m² of auxiliary space for laboratories, storage, and more. From the beginning, CuraFaktur's cleanrooms met the requirements of the EU-GMP guidelines, from GMP Class A to D. The laboratory has been operational, qualified, and handed over to CuraFaktur since December 2015.

Qualified cleanroom

The cleanroom complex designed and built by Weiss Climate Technology for CuraFaktur consists of two air-handling separated areas for sterile production and the manufacture of toxic products. It is a "room-in-room" solution with an isolated, airtight wall system. The supply air is provided via HEPA filters. Weiss installed the climate technology in a space-saving, enclosed internal central unit. The system — especially the ventilation technology — operates very energy-efficiently.

The wall and ceiling construction is seamless and easy to clean. Access is via personnel and material airlocks, which are equipped with interlocked doors to prevent simultaneous opening. This ensures that the critical working area regarding the room climate is securely isolated from the environment. Access to the cleanroom and laboratory areas is regulated by electronic access control for authorized personnel.

"As a result, it is guaranteed — as recommended by GMP guidelines — that material and personnel flows are separated, so that neither the medical staff working here, nor cleaning personnel or technicians, can introduce particles into the room," explains Dr. Thomas Fink from CuraFaktur. The layout of the cleanroom has been specifically designed so that different products or production steps can be processed simultaneously at various workstations. The different cleanroom classes are separated by corresponding sluices — especially the flow of goods in and out occurs via two separate routes. The same applies to the pre-preparation stations, where customers weigh and fill the substances needed for their medicines.

WIBOject safety workstations from Weiss Pharmatechnik GmbH

The Weiss Pharmatechnik GmbH, formed in 2015 from the merger of Weiss subsidiaries BDK in Sonnenbühl and Weiss GWE in Hude, was involved in the project as another key partner for the supply of workbenches.

All WIBOject safety workstations in GMP design and workbenches from Weiss Pharmatechnik required for this project were custom-made at the Hude and Sonnenbühl locations, installed on-site, and put into operation. The selection and equipment of the workbenches took into account frequent product changes and the need for specific small batch production.

Perfect collaboration under tight schedule

The entire project benefited from the excellent partnership between Weiss Climate Technology and Weiss Pharmatechnik in planning and technical execution. This was evident in the intensive collaboration on planning documents, clarification of airflow interfaces, and coordination of assembly sequences, so that mutual obstructions could be avoided. The employees of the main suppliers involved have known each other for a long time and are also active in the VIP 3000 association — the interest group for pharmaceutical construction. Throughout the process, especially in scheduling, everyone worked in unison, ensuring the ambitious timeline was met.

Dr. Thomas Fink from CuraFaktur is fully satisfied with the process. "We examined quite a few companies beforehand. Weiss Climate Technology convinced us from the start, despite our quite complex requirements. During the planning phase and throughout the entire construction, the staff of Weiss Climate Technology and Weiss Pharmatechnik demonstrated their high competence and flexibility in designing and setting up demanding cleanrooms. The project was then completed on time and within the planned budget."