Vetter Pharma-Fertigung GMBH & Co. KG, Contract Manufacturing Facility, Ravensburg, Germany

The German company Vetter Pharma-Fertigung GmbH & Co KG is one of the best-known companies in Western Europe for the contract manufacture and aseptic filling of pre-filled syringe devices for the burgeoning parenterals market.

In recent years they have been expanding their production capacity because the demand for their specialist services is so great. Consequently they now have a new facility near to their headquarters in Ravensburg. The new facility has been called Ravensburg Vetter South (RVS).

Vetter is a contract manufacturer specialist in the aseptic filling of liquid and lyophilised drugs for international biotechnology and pharmaceutical companies and a worldwide specialist in the aseptic production of FDA-approved pre-filled application systems.

The company employs over 1,800 employees and all of their established production plants are FDA approved. Before the new plant they had a total production capacity up to 400 million units per year.

The company currently manufactures 18 different client products with FDA approval. The company is a lyophilisation (freeze-drying) specialist and holds 127 patents including solutions for protection against copying and counterfeiting. Vetter has global experience and expertise with all of the recognised regulatory authorities across the world.

CONSTRUCTION

The New Facility Ravensburg Vetter South (located in the commercial zone Mariatal/Ravensburg South) took a total of 36 months from the start of the detailed design of the facility to the complete validation.

Detailed design started in November 2003 and construction started in February 2004 and completed by December 2005. Performance qualification (PQ) validation of the facility was completed by December 2006.

The total size of the facility is 16,000m² with the production area having a floor space of 2,920m². In addition to the main building, a technological building was built with steam production units and an emergency power supply. Also a laboratory building houses facilities for chemical and microbiological analysis.

The company began preliminary operations at the facility in October 2006 and its production site currently has two filling lines, which will be expanded to four by the end of 2007/start of 2008.

Production began properly in January 2007. The facility has benefited from over 25 years of experience in the pre-filling of syringes. The automation was planned throughout the facility, and includes door openers for use with the brand new Restricted Access Barrier System (RABS) on the filling lines.

The plant features maximum automation; high standards of sterility, safety and quality; self-sufficient production site with its own utility and power supply; unique production lines; and a capacity of 90 million units per year.

RVS was designed to meet all of the challenges that technicians and scientists are faced with when aseptically filling syringes, cartridges, and vials. The construction and outfitting of the new plant required an investment of €100m.

The new facility won the ‘Facility of the Year Award’ in 2007 for Process Innovation. In April 2006 Vetter Pharma-Fertigung GmbH & Co KG purchased land adjacent to the new Ravensburg Vetter South production plant.

The company plans to build a new facility for packaging and automated optical inspection, as well as to offer room to expand its aseptic production capacity when required.

CONTRACTORS

The architect and designers of the facility was the Vetter planning team at Ravensburg, Germany. Technical building management was the remit of Axima GmbH of Cologne, Germany. Structural planning was carried out by Schneider & Partner Planungsgesellschaft mbH of Ravensburg, Germany.

Other contractors for the project included SiGeKo (health and safety coordinator), Georg Reisch GmbH & Co KG, Friedrich Burk GmbH & Co KG, Dieter Eitle GmbH, Kirchhoff-Heine StraBenbau GmbH & Co, Manfred Wucher GmbH, Peter Wiedemann GmbH, Johann Engler GmbH, Heinz Müller GmbH & Co KG, Loos Deutschland GmbH, Ondeo Industrial Solutions GmbH, Stilmas Spa, Atlas Copco Kompressoren und Drucklufttecknik GmbH, Huber & Ranner GmbH, GSA Euro-Diesel GmbH, Elektro Stotz GmbH & Co KG, Siemens AG/SSG Starkstrom Systeme GmbH and Axima Refrigeration GmbH

These were joined by Adept Technology Inc, Robert Bosch GmbH, Binder GmbH, BHT Hygienetechnik GmbH, Belimed GmbH, Gastec GmbH, Föratec GmbH & Co KG, Hof Sonderanlagenbau GmbH, Inova Pharma Systems GmbH, Montech Deutschland GmbH, Motus Engineering GmbH & Co KG, Pink GmbH, Manfred Roth Edelstahl-Behälter und Apparatebau, Ruland Engineering & Consulting GmbH, SBM Schoeller-Bleckmann Medizintechnik GesmbH and Weiss GWE GmbH.

PRODUCTS

The facility is set up for the contract manufacturing of innovative pharmaceutical products for parenteral administration (syringes for injection). Products produced at the plant include filled dual-chamber syringes and cartridges containing lyophilised/liquid and liquid/liquid; filled vials with either lyophilised or liquid contents or filled liquid cartridges.

The production plant has a filling line for dual-chamber systems with and without lyophilisation as well as a combination line for cartridges and vials with and without lyophilisation; both have been in production since January 2007. The new Ravensburg Vetter South production plant has raised the companywide production volume of pre-filled syringes to a total of almost 400 million units, an increase of about 30% over the previous capacity of 300 million units.

The company has three other similar facilities in and around Ravensburg, including two aseptic filling facilities and one final packaging facility. The company believes it is important to concentrate production in the Ravensburg region.

The facilities are independent from each other but have almost identical production processes. This new increase of production lines gives operational back-ups and allows easy expansion of production if required.