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Pharmaceutical Manufacturing and Packing Sourcer

The Challenge of Biotechnology

Helmut Sommer of Christ Water Technology Group examines the treatment of critical waste water in the pharmaceutical industry

Today, biotechnology plays a major role in the pharmaceutical industry. Many products, especially vaccines and therapeutical substances, are manufactured with the aid of biotechnological methods. New production processes and technical advances, the human genome project, for example, are contributing further to this development. In the next few years, an annual growth of about 15 per cent is predicted for biopharmaceuticals, while the growth rate for conventional pharmaceutical products is expected to be only about five per cent. However, this increase also means that attention must be paid to the biologically contaminated waste water generated by these processes. This article presents the state-of-the-art decontamination process technology and describes the advantages offered by systems in which all stages – from the production of ultra-pure water to the disposal of the waste water – are supplied by a single manufacturer.

SPECIFIC PROBLEMS IN THE MANUFACTURE OF BIOPHARMACEUTICALS

Biopharmaceuticals are manufactured by fermentation with microorganisms or viruses. The production methods for such products thus differ greatly from those used for conventional pharmaceuticals. If, for example, a plant produces vaccines, the waste water from the fermentation stage must be examined and treated very carefully.

Depending on the biological safety class (BL 1, BL 2 or BL 3), all waste water from a biotechnological production system must be treated – in general, this means sterilised – such that no microorganisms can enter the factory’s waste-water treatment plant and that there is absolutely no potential contamination hazard for the environment. This decontamination of the waste water is generally carried out with a batch-mode or continuous sterilisation system.

The waste water frequently contains a mixture of fermentation residues, as well as microorganisms and the water used for flushing and CIP. Its composition may vary widely and it may also contain solid particles. The treatment systems must therefore be very robust and designed to be extremely safe. The treatment of biological waste water is thus a key function of a biotechnological production system.


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Helmut Sommer, Sales Manager at Christ AG, graduated with a degree in Mechanical Engineering from the Polytechnic Institute of Braunschweig, Germany. After this he worked in digital imaging processing and automation systems at Mc Cune & Stewart as a Project Engineer and Technical Manager. Helmut then worked at Pharmaplan and Pharmatec in Bad Homburg and Dresden, planning and developing water plants, in particular WFI and ultrapure steam generators. He has been at Christ AG, Switzerland, since 2003, as a Sales Manager for pharmaceutical plants, and is responsible for the further development of Multitron and Vapotron.
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Helmut Sommer
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