Gerresheimer develops pharmaceutical filling line for cleanroom environment

Düsseldorf/Regensburg, December 16, 2011 - Gerresheimer Medical Plastic Systems produced a complex medical technology product on behalf of a leading pharmaceutical company. In addition to the optimization for plastics processing, industrialization and production, Gerresheimer Werkzeug- und Automatisierungstechnik planned and built a pharmaceutical filling system for clean-room operation to ISO class 7 EN ISO 146441-1/. Gerresheimer Regensburg loaded the first clinical samples, which were required for clinical studies and approval.

The line was developed and designed in close cooperation between Gerresheimer Regensburg GmbH, Gerresheimer Werkzeug- und Automatisierungstechnik GmbH (the mold and automation department of Gerresheimer Medical Plastic Systems) and the customer. As both the industrialization of the product and the development of the filling line were subject to a tight schedule and carried out by simultaneous engineering, a detailed coordination between the involved departments and the customer was of utmost importance. The filling line concept took into account the flow of goods, the existing transport equipment and the airlock technology used in the pharmaceutical company’s clean rooms. The pharmaceutical filling line was also coupled with the downstream packaging line. Manfred Baumann, COO/CTO of Gerresheimer Regensburg, explains why he considers the coordination of both lines as one of the major challenges of this project: “The ISO class 7 filling line and the ISO class 8 packaging line are separated by airlocks. Moreover the cycle times of both lines and even the breaks of the staff operating on both sides of the airlock are different. Together with the university of applied sciences HAW Weiden-Amberg, we developed a transport concept to solve this issue. Computer-aided simulation engineering helped us to develop a buffer/stock solution which ensures a smooth continuous production process.”

The pharmaceutical filling line complies with EN ISO 146441-1/EN ISO class 7 and meets the standards of Good Manufacturing Practice (GMP) and Good Automation Practice (GAMP). Extensive FMEA assessments were carried out so as to control the litigation risks of machines and equipment. A special control system is responsible for data management and transmission. Commercial filling will be performed by the customer.

About Gerresheimer

Gerresheimer is an internationally leading manufacturer of high-quality specialty products made of glass and plastic for the global pharma and healthcare industry. Our comprehensive portfolio of products extends from pharmaceutical vials to complex drug delivery systems such as syringe systems, insulin pens and inhalers for safe medication dosage and application. Together with our partners, we develop solutions which set standards and have role model status in their respective market sectors.

Our Group has production operations at 45 sites in Europe, North and South America and Asia. It realizes sales of around one billion euros and has 10.000 employees. We use first-rate technologies, convincing innovations and targeted investments to systematically consolidate our strong market position.

Press contacts
Marion Stolzenwald
Gerresheimer AG
Benrather Straße 18-20
40213 Düsseldorf
Phone +49 211 6181-246 
Fax +49 211 6181-241 
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Karin Strasser
Gerresheimer Regensburg GmbH
Bischof-von-Henle-Straße 2b
93051 Regensburg
Phone +49 941 7058-140
Fax +49 941 7058-146 
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