Training at Bausch + Ströbel
USA customer sends personnel to Ilshofen for intensive training on 10.5 million euro machine
A filling and closing line worth 10.5 million Euros for a US pharmaceutical company represents the result of an extremely intensive planning and realization phase of an individual order.
Already in 2006 the first negotiations started between the Ilshofen-based custom machine manufacturer and the US pharmaceutical company, whose name Bausch + Ströbel is not entitled to give away. As biotechnologically produced hormone drugs and medications for cancer therapy are to be processed, the requirements for sterility, traceability of every individual vial as well as for the checking stations are extremely high. As the products being filled are extremely expensive only marginal amounts may remain at the end of a batch. "One liter of residual product costs up to 2 million Euros", says Frank Härterich.
That's the schedule: In May 2007 the order was placed - and by the end of 2012 the production line is to start up at the customer's premises. The filling and closing technology is provided by Bausch + Ströbel, and the isolator which guarantees aseptic production conditions is delivered by the Swiss company Skan AG. "Usually isolator and machine are joined at site", says Werner Wieland, head of the construction department. However, the US customer wants to see the complete machine in action at Bausch + Ströbel. According to executive director Siegfried Bullinger the customer has provided packaging material (glass vials, stoppers and metal caps) worth 2.5 million Euros for the test runs which is thrown away afterwards.
Approx. 400 square meters are reserved for the line in the new production hall which was built in 2009. At the customer's premises the machines are located in three different rooms. In the first room the vials are unpacked, in the second room they are filled and closed, and in the third room the vials are packed in trays for transport and are counted by a camera.
How has Bausch + Ströbel attracted this US company as a new customer for this large-scale project? "The customer is confident that we are capable of keeping our promises", says Wieland in view of the strong competition. Bausch + Ströbel has already proved its flexibility: During the realization of the project the customer requested the individual coding of every single vial. The Ilshofen-based company solved it by applying a code to the closure with a laser coding unit. In this production line 36,000 vials per hour can be washed and sterilized and subsequently filled and closed under clean room conditions. Several long sleeve and glove assemblies permit intervention in the machine without impairing sterility. After the FAT the customer's qualified pharmaceutical personnel will stay for six months in Ilshofen for training on the machines during which test runs with the original product will also be carried out.
