Nycomed

Most of us know at least one of Nycomed's products from childhood on: Sanostol, as a nutritional supplement, is an advertising icon from the 1970s and 1980s to the same extent as Buerlecithin, also produced by Nycomed, is for the older generation. To ensure that nothing makes you feel sick with anger in your professional life between these two periods, the portfolio of the international pharmaceutical company also includes numerous medical products, for example for stomach discomfort and diarrhoea. Further focal points of activities are medicaments for respiratory and cardiovascular diseases, pain therapy and osteoporosis.

In Germany, Nycomed GmbH operates from four locations. In Constance, research and development, marketing and distribution are bundled. Another location for further research activities is Hamburg. Production takes place in Oranienburg and Singen. While all kinds of solid forms of medicaments - meaning tablets, film capsules and capsules - are manufactured in Oranienburg, the activities in Singen focus on the sterile and non-sterile production of medicaments in bottles, ampoules, syringes or tubes.

Nycomed supplies medicaments which are only available on prescription to more than 100 countries worldwide. Therefore Nycomed, as a matter of course, is geared to meeting even the strictest international standards for pharmaceutical production. This applies to the production processes themselves as well as to supporting processes and the media supply. The specification for air for medical use concretely refers to the Pharmacopoea Europaea or to the United States Pharmacopeia (USP) and the National Formulary (NF) of the American Food & Drugs Administration (FDA), in accordance with which the production in Singen is certified. Expressed in the better-known ISO-8573 classification of compressed air quality, Nycomed defines class 1 as a requirement for the residual oil content, class 1 for particles and class 4 for the residual moisture content.

The Nycomed factory in Singen has two separate compressed-air systems with an operating pressure of 6 and 10 bar. The 6-bar system, which is fed by two compressed-air stations, supplies compressed air to the pharmaceutical production, the chemical production and the chemical pilot plant stations. There, the air serves as control air and as an energy carrier for the operation of pneumatic devices. In pharmaceutical production, the compressed air is used as a cleaner and dehumidifier for primary means of packaging such as ampoules, for the aeration of the sterilizer chambers and for product superposition in manufacturing. And it is exactly these processes where the extremely high demands on safety that Nycomed makes on the compressed-air supply. For the production, they need compressed air guaranteed free from oil, and this must be ensured 24 hours a day, seven days a week."

An elaborated and stringently planned safety solution for the compressed-air processing, one could already say at this point, but for the safety requirements according to the specifications of the technical department this does not suffice: to be prepared for all contingencies and for maintenance periods, the station also accommodates an additional activated-carbon adsorber made by BEKO with a CLEARPOINT activated-carbon filter 0.01 µm in the bypass. This "police" filter represents an additional firewall to protect the production against oil introduction via the compressed air. A downstream calibrated pressure dew point and residual oil content measuring device in the compressed-air manifold continuously monitors the pressure dew point and the residual oil content. If limit values are exceeded, an alarm is signaled to the control room via the central building control systems. Only after this safety level is the compressed air supplied via pressure vessels to the distribution system for the compressed-air consumers.