PTA Pharma-Technischer Apparatebau installs new weighing system at pharmaceutical manufacturer CESRA

Construction of the PTA laminar flow system within production. (Image: CESRA)

With CESRA Arzneimittel GmbH & Co. KG (CESRA), another renowned pharmaceutical company relies on the modern cleanroom technology from PTA Pharma-Technischer Apparatebau GmbH & Co. KG (PTA). The specialist for the production and distribution of phytopharmaceuticals uses a PTA - Laminar Flow System for the efficient weighing of high-quality raw and active ingredients. The new system replaces a solution provided by PTA years ago, with the goal of modernization and increasing capacity due to CESRA's strong growth. The decisive factors for the new order were, in addition to the high processing quality and the use of pharmaceutical stainless steel, mainly the satisfaction with the previous system and PTA's customer-oriented service policy. The system was installed at CESRA in February of this year.

CESRA ("Corpus et Sanum Rastatt") was founded in 1929, is a traditional specialist in the production and distribution of phytopharmaceuticals according to GMP guidelines, and has a state-of-the-art production facility in Baden-Baden. Since 1996, CESRA has been using PTA's laminar flow technology for processing pharmaceutical raw and active ingredients. As CESRA claims to rely on "state-of-the-art" technology in its production, they decided to replace the aging system. Another important point, according to Torsten Zoller, Technical Project Manager at CESRA, was the company's strong expansion, especially into China, where CESRA has already become a market leader with one of its products.

Thus, the new system, a free-standing weighing station as an exhaust cabinet with a workspace of 3,700 x 2,700 mm, is four times larger than the previous one under the downflow. Additionally, CESRA has placed increased emphasis on product and personnel protection: The new PTA laminar flow system offers exceptionally high protective features for the products, operating personnel, and the associated production environment. Due to the partial irritant effect of the substances processed, extensive safety functions and a total of three filtration stages, including a particle filtration, were implemented. Energy-efficient fans, which consume significantly less power, as well as energy-saving LED lamps, complete the sophisticated equipment.

Special system concepts for complex spatial challenges

To achieve CESRA's goals, it was necessary to install the system directly into the pharmaceutical production area, considering the spatial conditions. This proved to be a conceptual challenge from the outset, as the planning of the system modules required integrating the raw ceiling construction and existing ventilation ducts, so that, for example, the downflow module had to be carefully adapted to one of the existing ventilation ducts. The implementation of the project also proved to be extremely demanding: while the system was brought in via a crane through the open facade, PTA also had to set up a chilled water unit with buffer tank on the roof to establish a completely independent cooling water cycle. CESRA placed great importance on excellent cooling options to create ideal climatic working conditions for personnel in the weighing cabinet, as such workplaces are often very warm. Additionally, PTA installed a hydraulic softener in the mezzanine to reduce pressure fluctuations, power consumption, and noise, as well as to increase the lifespan of the system.

In everyday operation, the new PTA laminar flow system impresses, among other things, with its simple operation and trouble-free operation. The SPS control is via Simatic S7 with a touch panel, which visualizes operating parameters on a compact surface without impairing readability. Furthermore, the system's large surfaces and few joints make it easy to clean, which was also very important for CESRA. CESRA is very satisfied with the execution: "We requested several suppliers before purchasing. PTA convinced us again with the consistently high quality of the system," said Torsten Zoller. "For us, PTA is a cooperative and competent business partner who has flawlessly met our sometimes very complex requirements in terms of technology, conception, and implementation of the system."

Rüdiger Dilg, owner and managing director of PTA, explains: "We are very pleased with CESRA's repeated decision to choose PTA. Highest product and processing quality, as well as the use of state-of-the-art technologies, have always been our core competencies, which are repeatedly confirmed through our long-standing customer relationships." Dilg further states: "We are strong in the conception and realization of systems that need to be integrated into existing production environments. We have extensive experience and solid expertise gained from many complex projects. That’s why we can offer solutions even in very challenging production environments, as in this CESRA project."

PTA Laminar Flow Systems

Laminar flow systems (or sample, test, or weighing cabinets) are used where pharmaceutical active ingredients and substances are processed, and both these and the personnel involved need protection from contamination.

In PTA systems, process air is recirculated (room-to-room system) via HEPA filters with low turbulence, directed downward in a vertical flow. The constant recirculation ensures that substances released during operation are directed downward. This keeps personnel safe and reliably protected from inhaling particles of the substances being processed, and also shields the installation room from contamination. Finally, the pure weighing cabinet from PTA offers the highest protection for the active ingredients being processed, thanks to recirculation and displacement airflow concepts, preventing contamination from particles in the production environment. The use of PTA systems achieves the highest product purity.

The systems (stainless steel 1.4301, also in ATEX) are manufactured according to ISO 14644-1 and VDI 2083, as well as customer-specific specifications. The complete project execution is carried out in-house (design, manufacturing, and functional testing) in Germany ("Made in Germany"). PTA also handles assembly and commissioning and offers extensive service and maintenance programs.