Invest - In the production of pharmaceutical substances, water is one of the main raw materials and, as such, subject to strict quality requirements. Its treatment is thus of extreme importance, and the use of innovative technology ensures very high and reliable quality and efficiency.

The manufacture of pharmaceuticals is subject to a constant flood of new regulations and incurs great responsibility with respect to customers and patients. Sandoz has complied with these requirements for many years and thus invest continually in new high-tech solutions. Kundl, a small town in Tyrol with about 4,000 inhabitants, is home to the largest Sandoz development and production facility in the world. The facility was originally founded in 1946 under the name Biochemie and today employs about 2,400 people. In addition to antibiotics, it produces enzymes, hormones and biotechnical substances. The indispensable high quality pure water also has to be produced on-site.

The highly automated production equipment therefore includes a pre-qualified, GMP-compliant compact system for the production of purified water (PW) in accordance with USP. Since 2007, the two existing water-treatment systems have been supplemented by an Osmotron 9000 Pharmaline from Christ. The quality of the PW produced in Kundl is in the order of ≤1.3 µS/cm and <100 ppb TOC. It is used at Sandoz for the manufacture of pharmaceuticals, as the basis for the production of water for injection, for the production of pure steam and for cleaning the production equipment. The PW is stored in a tank with a capacity of 100m³ and distributed from there to the various production buildings via a loop with a total length of 1.6 km.

Investment in Quality

Christ Pharma & Life Science was elected to be the supplier for the expansion of the pure-water production capacity at the Sandoz factory. Christ provided a matching solution in the form of an Osmotron 9000 Pharmaline. Georg Fuchs, manager of the energy division at Sandoz in Kundl, selected this unit because the total costs were lower than those of systems offered by other suppliers. "The unit was easily connected to the existing systems and its use helped to optimize our operating expenses. From a technical viewpoint, we were pleased by the short delivery time and the compact design of the unit, and also by the execution and documentation of the component qualification. In addition, our factory in Schaftenau had already purchased similar products from Christ and was very pleased with them."

The Osmotron 9000 Pharmaline consists of a water softener, a reverse-osmosis stage and an electro-deionisation (EDI) unit. In addition, in accordance with the requirements of Sandoz, it has an integrated membrane degassing module. The compact system which is easy and safe to operate is made of high-quality stainless steel and polypropylene and has no dead legs. It thus fully complies with the GMP (Good Manufacturing Practice) guidelines. All components are easily accessible for any necessary inspection and maintenance and can be cold-sanitised with hydrogen peroxide. This compound of hydrogen and oxygen has a strong bactericidal effect and thus permits environmentally friendly and technically simple disinfection. A facility for extraction of samples after each process step stage ensures compliance with the highest hygienic standards.

Professional Project Execution and Commissioning

In the period between award of the contract to Christ and the final inspection, the project team was faced with a very tight schedule. The Osmotron 9000 Pharmaline was delivered to the installation site in Kundl and had to be lifted with a crane and lowered through the roof into its installation location. The unit was installed and commissioned one week later. All necessary on-site work was carried out without disturbing normal production. „The unit was installed, connected and activated while the plant continued operation. FAT and SAT guaranteed rapid and simple commissioning," confirmed the Sandoz project manager.

All system components are pre-qualified at Christ Pharma & Life Science in a factory acceptance test (FAT). This is done in the factory, using original service media, making it possible to carry out some phases of the IQ (Installation Qualification) earlier. The inspection checks that all components are correctly installed, that the system functions correctly and that the system documentation is complete and correct. Thus, any functional defects or non-compliance with the specifications are detected before the system is commissioned. This, in turn, means that activation of the system can be done more quickly and that the number of risks is reduced. Christ was also present in Kundl for the site acceptance test (SAT).

Fully Automatic Control System

Special requirements exist for the control and monitoring of the PW supply at Sandoz. Operational safety, data security, reliability and ease of operation play a special role. Due to the fully automatic operation of the Osmotron, the risk of incorrect operation is minimized.

The compact system is controlled by the control system WinCC; it is operated and monitored with the aid of an integrated touch-panel PC 477 with a 12-inch screen, on which the current operating status of the water treatment systems and the process systems can be visualized at any time. The optical operating panel permits the graphical display of all functions and the system status at a glance.

At Sandoz in Kundl, the three systems are controlled via the central process control system (PCS) of the factory power department. The PW production is controlled on the basis of the level in the 100m³ storage tank. If the level in this tank drops to 85%, the two existing systems (each with an output of 8m³/h) are first started, since their outputs can be regulated in the range 5-8 m³/h. If the level in the tank drops further to 80%, the Christ system is started up and continuously produces 9m³/h of PW.

The monitoring of all documents and data files, and also the logging of all modifications, is carried out automatically and without time-consuming manual intervention. Additional process-control modules make it possible to trace all operator actions and changes to the project. All modification data are stored in a database, the audit trail. The generated data is stored in a tamper-proof form in accordance with CFR Part 11 and cannot be manipulated or deleted.

Partner for Water Treatment

From the very beginning, Christ Pharma & Life Science was a competent and reliable partner for Sandoz - from the planning phase to the commissioning of the compact system. The project management at Kundl was not only pleased by the fast and easy integration of the new Osmotron into the existing system, without interruption of normal production but also with the uncomplicated fulfillment of individual customer wishes and the efficient optimization of processes and costs.