Quality assurance is top priority
In pharmaceutical production quality assurance plays a fundamental role, because fluctuating quality can have a direct impact on the health of the consumer. A quality management system that complies with good manufacturing practice (GMP) ensures product quality and meets mandatory health authority requirements. Furthermore, pharmaceutical manufacturing approval processes require flawless documentation. Experts are required here – our employees. They know the processes in detail and thanks to their professional project management; they supervise plant construction in detail – from planning to the start of production.
provide exemplary insights into the diversity of projects as parts of a broad spectrum of experience. Further references on request under firstname.lastname@example.org.
Conversion of an existing chemical facility into a sealed production line (dust, liquids, steam) during operation, the integration of new apparatus and capacity expansion of reactor plant units.
These products are produced in the world’s biggest facility of its type. Modern process control systems run the production facility economically and efficiently. Specifically locally installed and centralised environmentally friendly technologies avoid or minimize emissions.These large-scale production lines for the manufacture of vitamins are maintained, repaired and modernized on an annual basis to meet current demand and achieve a high yield.
The production process of the substance was overhauled and a second production line is being implemented on top of the first three. Afterwards the production process will be integrated into the existing processes. To do this, unnecessary parts of the system must be dismantled, new ones introduced, and the system installed and put into operation. The ongoing production on the first production line severely restricts the work.
Construction of a biotechnological pharmaceutical production facility for the production of monoclonal antibodies for the treatment of cancer.
Construction of a pharmaceutical facility for the production of medicine in Singapore.Over multiple planning stages the final layout for this investment project for a site for biotechnological production lines was developed and realised.
The project expands the manufacturing of an insulin product to two production lines with all the necessary plant technology upgrades. To do this the building must be expanded, the facility assembled and connected to the existing one and qualified. Because production line 1 must continue producing, the work must be sealed off from the clean rooms so as not to endanger production. The project includes two shut downs in which connections and commissioning have to be implemented under high time pressure.
The pharmaceutical giant GlaxoSmithKline (GSK) isn’t shying away from the much-maligned pharmaceutical location of Germany: for more than 90m euros the British company enlarged its production facility for flu vaccinations in Dresden. By the 2008/2009 flu season annual production of the vaccine had been doubled.
Novartis AG is investing in its Stein site in the construction of a new solids launch facility, a production facility for solid medicines. The multi-level construction is 160 meters long and 80 meters wide. In the future on a total area of approx. 60,000m2 it will house production and quality control as well as administrative functions.
The project involved the production of a new clinical sample production area. To this end, a complete floor (1700m2 GFA) will be expanded in an existing building and the current old plant closed.
In the clinical sample production area there is no clearly defined product portfolio, therefore used process technologies and stages can vary. The focus of the facility is on the provision of the widest possible range of production technologies, not maximum productivity.
In the new clinical sample production area highly potent substances (OEB 4/5, MEL 4) are handled, the GMP standard improved and the employee safety brought up to the latest technical standards.
Implementation and management of safety features on pharmaceutical packaging.
Implementation of a system for online coding, serialisation, product tracking, feature verification and OPN – Online Printer Novartis.
Project for the implementation and management of safety features on pharmaceutical packaging. Global roll out of the features on all packaging production sites worldwide. E.g. for the U.S. market 45 lines (incl. 23 contractor lines) at 15 sites in 6 countries were modified.
The increasing demand for the traceability of pharmaceuticals from manufacturing to the consumer require the construction of complex tracking tools via packaging labels and underlying data that are available to users worldwide. In the project created for this purpose the regulations required on the basis of each country’s legislation are implemented and incorporated into the global structure of the pharmaceutical company. In a change process all affected production areas and departments are integrated and trained in this process.