A pure heart

The construction of the cleanroom by Weiss Klimatechnik included everything from the screed to the complete ventilation system, electrical wiring, cleanroom and sluice furniture, safety cabinets, laminar flow system, and autoclaves.

General contractor Weiss Klimatechnik only needed eight months for the project – from contract award to GMP qualification.

With the introduction of the new cleanroom concept, the hospital pharmacy now meets not only the requirements of the Pharmaceutical Operating Regulations but also possesses one of the necessary prerequisites for obtaining a manufacturing license according to § 13 of the Medicines Act.

The climate control systems were adapted to the two functional areas of cytostatics and sterile manufacturing of the pharmacy.

Weiss Climate Technology, as general contractor, has equipped the hospital pharmacy of the Heart and Diabetes Center NRW (HDZ NRW) in Bad Oeynhausen with a new heart suite: a GMP cleanroom for the production of medicines for internal use as well as for external customers of the house. At the end of August this year, the Weiss Climate Technology team handed over the turnkey cleanroom.

The Heart and Diabetes Center NRW (HDZ NRW), Bad Oeynhausen, is one of the leading clinics in the treatment of heart, circulatory, and diabetes diseases. The range of services of the university clinic of Ruhr University Bochum is internationally known: With more than 250,000 heart catheter procedures and over 110,000 heart surgeries, the HDZ clinics in cardiology, thoracic, and cardiovascular surgery are among the leading heart centers worldwide. With over 70 procedures annually, the HDZ NRW is also the largest heart transplant center in Europe.

Clinic Pharmacy Business Area

A business area that is generally less perceptible to patients and visitors but very important for the clinic is the hospital pharmacy of the house, with around 20 employees (pharmacists, pharmaceutical-technical assistants (PTA), and pharmaceutical-commercial staff (PKA)). The pharmacy supplies the wards and functional units of the HDZ as well as 20 other clinics and facilities with medicines – including a hospital and several rehab clinics. Overall, they cover the needs of approximately 4,500 bed allocations, explains Anke Möller, specialist pharmacist for clinical pharmacy and head of the hospital pharmacy. About 75,000 medication packages are constantly in stock in the main warehouse of the pharmacy. The pharmacy dispenses approximately 1.2 million packages per year. Annually, about 450,000 items are distributed to the wards.

With the new cleanroom, as built by Weiss Climate Technology for the HDZ NRW, they are preparing for changes in the pharmacy operating regulations, explains Anke Möller. It sets new spatial requirements for the sterile production of medicines: certain cleanroom classes must be maintained – including a secure sluice concept. This applies, for example, to the cytostatic solutions produced in the pharmacy for the oncological rehab clinics and some special sterile medicines for the clinic for thoracic and cardiovascular surgery of the HDZ NRW.

Turnkey from the General Contractor

The decision to commission Weiss with the pharmacy project was made within a negotiation procedure, reports Marc Lohmeier, the technical manager of HDZ NRW. "Weiss Climate Technology convinced us with the best overall package and an economically and technically practical concept," says Lohmeier. This was complemented by Weiss Climate Technology's long-standing experience and its specialized knowledge in cleanroom and process technology. The center has been working with Weiss Climate Technology's Mediclean division for years – for example, in equipping with special operating room drapes.

For the 250 m² construction of the new pharmacy cleanroom, it was crucial for the clinic center that, in addition to complying with all legal regulations, the very high hygienic standards within the house were observed: "The entire construction process had to be designed so that other areas remained unaffected," says Marc Lohmeier. "The Weiss Climate Technology team, with its project manager Hans-Joachim Weitzel, managed this very well despite the existing time pressure. It also helped that the company acted as the general contractor and managed the entire project from building application to turnkey handover. But the very good communication between Weiss technicians and the pharmacy team was also decisive."

Qualified Cleanroom

The new cleanroom complex consists of two air-technically separated areas for sterile production and the manufacture of cytostatics. It is based on a room-in-room solution with an isolated and airtight wall system. The supply air is provided via HEPA filter outlets. Weiss installed the climate technology in the form of a space-saving, enclosed indoor central unit. The system – especially the ventilation technology – operates very energy-efficiently: Weiss Climate Technology has contractually committed to guaranteeing maximum energy consumption.

The wall and ceiling construction is surface-mounted and easy to clean. Access is via sluices – sluice controls prevent the simultaneous opening of sluice doors, ensuring the critical working area regarding room climate is securely isolated from the surroundings. Unauthorized access is also prevented by a dedicated access control system.

The climate systems have been adapted to the two functional areas of cytostatics and sterile manufacturing of the pharmacy. For the cytostatic area, a climate cabinet system with a pre-installed separate outdoor air preparation system, manufactured by Weiss, was installed. This supplies the cytostatic area with an outdoor air and exhaust air system. A portion of this outdoor air is used to supply the sterile area, providing the necessary outdoor air for the recirculation system, which is also equipped with a climate cabinet system, to ensure process exhaust air and maintain the required positive pressure.

Qualification and Service Management

Commissioning within the framework of the global flat-rate contract, with a volume of approximately €1.5 million, initially included the complete dismantling and decontamination of the existing system, as explained by Weiss project manager Hans-Joachim Weitzel. The construction of the room included everything from the screed to the complete ventilation system, electrical wiring, cleanroom and sluice furniture, safety cabinets, laminar flow system, and autoclaves. Additionally, a monitoring system with particle counters, required for A-grade cleanrooms, was installed. The project duration from order placement to GMP qualification (Good Manufacturing Practice) was only eight months: it includes the qualification stages DQ (Design Qualification), IQ (Installation Qualification), OQ (Operational Qualification), and PQ (Performance Qualification).

The system is contractually secured under Weiss service management. With service support points distributed across Germany, Weiss is always close to its customers. Well-trained staff, high security in spare parts supply, and quick response times are also important criteria for Weiss as the general contractor and service partner for the HDZ Bad Oeynhausen.

Weiss is known for managing projects of this size and complexity from planning to handover as the general contractor. "In our opinion, not only the climate technology expertise is important," emphasizes Karl-Heinz Lotz, head of the Strategic Business Area Cleanroom at Weiss Climate Technology. "Only when I, as a system builder, master the necessary processes and procedures or understand them, can I as a planning company create an optimal layout. This layout, along with the applicable regulations, standards, and technical requirements, guides the equipment of the system, e.g., climate technology or process media supply and equipment."

Ready for Expansion

With the introduction of the new cleanroom concept, the hospital pharmacy now meets not only the requirements of the pharmacy operating regulations but also has the spatial prerequisites for obtaining a manufacturer’s license according to § 13 of the Medicines Act. "This manufacturer’s license," says pharmacy director Anke Möller, "could, for example, make us a manufacturing facility for clinical trial preparations. Currently, there are very few of these in Germany."

In the future, the hospital pharmacy will also produce parenteral nutrition for the pediatric cardiology clinic of the HDZ NRW – the cleanroom is also a prerequisite for this. "Thanks to the new cleanroom concept," says Anke Möller, "we are able to supply sterile medicines to potential new customers as well. This will allow us to expand our service scope in the long term."