Vial and ampoule filling lines

When hameln pharma decided to build a new sterile facility factory to increase their production capacity in Hameln, Germany, they started looking for a reliable supplier of vial and ampoule filling lines who offered a short delivery time as well as compact design, energy efficiency and less training time for operators.

Hameln pharma, part of Hameln Group, has been focusing on the development, production and distribution of pharmaceuticals for over 50 years. Specialising in the contract manufacturing of parenteral medicines predominately used in hospitals and intensive care in more than 70 countries worldwide, hameln pharma has worked with Bosch Packaging Technology for many years. Currently, the oldest Bosch ampoule line still in use was purchased in 1985.

In 2006, hameln pharma decided to build a new sterile facility factory to increase the production capacity in Hameln, Germany. Within that new facility additional filling lines were planned to be installed so they started looking for a reliable supplier of vial and ampoule filling lines who offered the benefit of a short delivery time. Other critical process parameters in choosing the lines included compact design, energy efficiency and less training time for operators. After making comparisons, hameln pharma decided on Bosch.

In November 2006, hameln pharma ordered a vial filling line equipped with a universal washing machine, drying and sterilising tunnel, filling and closing machine and capping machine, and Bosch delivered within 12 months. During this time, in April 2007, hameln pharma ordered another ampoule filling line equipped with a universal washing machine, drying and sterilising tunnel, filling and sealing machine and colour coding machine. This time Bosch was able to deliver in December 2007, an even shorter delivery time than for the previous order.

The most important features of the vial and ampoule lines are the U-Shape with wall installation, and the inclusion of Restricted Access Barrier Systems (RABS) and Cleaning-In-Place and Sterilizing-In-Place (CIP/SIP).

To achieve maximum production efficiency, the vial and ampoule lines are set up in a U-shape with wall installation in order to greatly reduce the space required in the highest cleanroom class. The cleanroom class zone grade A can be kept smaller when using wall installed machinery, and maintenance measures inside the filling and closing machines can be partially carried out from cleanroom zone grade D, which reduces the contamination risk in zone grade B during maintenance or in case of repairs.

Another benefit of U-shape with wall installation is increasing the employee’s productivity. There is less movement needed for the operators in the cleanroom, especially between different cleanroom zones, increasing productivity and efficiency. The complete monitoring of the actual filling process in cleanroom class A can be done by the employee who remains in the neighbouring class B cleanroom.

“We met with Bosch extensively at machine manufacturing sites in Crailsheim and at Hameln to discuss our needs during the project planning, and we are very satisfied with Bosch’s fast delivery of vial and ampoule filling lines with our required U-shape and wall installation. This helps us to increase productivity and efficiency while meeting the cleanroom standards.” says Dr. Simone Dahlmanns, Operations Director from hameln pharma.

RABS further reduces the risk of contamination in cleanroom zone grade A since most of the production process can be carried out with the doors closed. Additionally, the filling machines are equipped with CIP/SIP equipment which further reduces the risk of contamination.

With the U-shape vial and ampoule lines with RABS, hameln pharma will expand their production capacity to handle a broader variety of container formats, batch sizes, potencies, formulations and product types. The efficient and flexible sterile facility has won the 2009 Facility of the Year Award for Operational Excellence.

“We have always trusted the reliability of the machines and service provided by Bosch. Their quick response time in answering questions, replying to our urgent requests and supplying solutions for special needs was critical to the success of this project. The lines from Bosch have created a positive experience for us based on the reliability of the machines. Furthermore, the modular build of the machines allow for lower storage levels of spare parts in Hameln, and in urgent cases, Bosch can deliver critical parts within 24 hours,” says Dr. Simone Dahlmanns, Operations Director from hameln pharma.