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Same space – three times the output

Tailor-made vial filling line for powdered drugs
Same space – three times the output

Designing a line that exactly fits into an existing space and boosts productivity at the same time is a challenging task. Despite the demanding set-up and a tight time frame, Bosch Packaging Technology accepted the challenge. Thanks to a consolidated effort, the processing and packaging specialist installed a tailor-made vial powder filling line for Tabuk Pharmaceuticals in Saudi Arabia within only a few months, while increasing the output to three times its previous amount.

Author Peter-Christian Rehm Project Manager Bosch Packaging Technology

The Saudi Arabian drug manufacturer Tabuk Pharmaceuticals produces its cephalosporin drug, an antibiotic, as a powder filled in sterile vials, enabling high stability. Cephalosporin is used to prevent infections before, during and after surgery as well as to treat respiratory tract, skin or other kinds of bacterial infection. By receiving the drug as powder, physicians are able to store it conveniently and only need to add a suitable solvent or water for injection (WFI) to make it ready for usage.
Despite its relatively short history, which began in 1994, Tabuk Pharmaceuticals is one of the largest drug manufacturers in the Middle East and North Africa with subsidiaries in over twenty countries. The company develops, manufactures, markets and distributes branded generics and licensed pharmaceutical products globally. At its site in Tabuk, the cephalosporin powder-type drugs used to be processed and packaged on stand-alone machines for each process step. As a consequence, the existing powder filling equipment, consisting of separate machinery, only achieved a maximum output of 60,000 vials per day. Rising market demand and an improvement in the process quality were the factors that triggered Tabuk’s decision to replace its existing equipment.
Decision for a big change
“Our project had two main goals: to upgrade overall capacity and improve product quality”, explains Dr. Hussein Mahmoud, Vice President Tabuk Plant Operation. Hence, the experts from Bosch were asked to develop a tailor-made line concept that fitted exactly into the 450 m2 production space where the existing machines were installed. After a thorough review of both the offer and the project schedule, Tabuk Pharmaceuticals decided to put the challenging plans into practice.
The new line consists of a large number of different components:
  • Washing machine and sterilisation tunnel manufactured by Bosch, Crailsheim
  • Filling, closing and capping machines also made by Bosch Packaging Technology
  • Pure media system and sterilisation equipment from Pharmatec and Schoeller-Bleckmann, two Bosch subsidiaries
  • Inspection and labelling machines from a third party supplier
“In Bosch, we found a supplier with profound line competence. They managed to integrate their own equipment into the limited space available perfectly within a tight time frame”, Hussein continues. “That way, we received exactly the filling line we were looking for, combined with excellent project management and engineering know-how.”
The new powder filling line includes an RRN 2053 washing machine and an HQL 3480 sterilisation tunnel to clean, sterilise and depyrogenise the containers. The heart of the line is an AFG 3020 powder filling machine, which operates according to the vacuum compressed air principle. It fills the powders into sterile injection vials with the highest precision possible without any dust. After the vials have been closed with rubber stoppers, the VRK 2005 capping machine makes sure that they are reliably sealed. Apart from these line components, Bosch also provided a complete solution for generating, storing and distributing water for injection (WFI) and pure steam. WFI is utilised in the washing machine as well as for cleaning certain format parts.
To prevent contamination, an autoclave is used to sterilise the format parts of the filling machine. The 250-S4 type WFI generation unit produces the steam required for the autoclave. Thanks to its special design, it is able to generate either WFI or pure steam – or both simultaneously, depending on the production requirements. After filling, the vials are inspected for container and product integrity, then labelled before they are ready for secondary packaging. The whole production line can be monitored from a centrally located office, where all process parameters are displayed on a single screen. This gives the plant manager a detailed overview of the filling process at all times as well as the option of controlling all steps carefully. One of the biggest challenges Bosch faced when planning the project was to keep production downtime to a minimum. The regular production processes of Tabuk Pharmaceuticals had to be affected as little as possible. “Since the experts provided a very detailed schedule, we were able to control all steps precisely, including the plans for the required cleanroom technology. This made the switch to the new line as smooth as possible”, says Hussein. Bosch started with the installation of the first new equipment components in July 2014. Only four months later, the site acceptance test (SAT) for the final line components was successfully concluded. “We are well aware that it usually takes more time to install such a line. However, Bosch managed to replace the existing equipment with production down for only eight weeks”, Hussein emphasises.
Working with experts pays off
When Tabuk Pharmaceuticals began production with the new line in December 2014, the first challenge entailed testing the weight variation of certain products, some of which needed further adjustment. The Bosch experts supported Tabuk Pharmaceuticals in finding the right dosing pestles for the different prod-uct types. Following this final optimisation, the newly installed line achieved the desired output of 300 vials per minute – nearly three times the figure for the previous equipment. “This is an astonishing result”, Hussein remarks. “It was definitely a big change to our facility, but it was well worth it. Apart from achieving a capacity boost, we now also have the most advanced GMP-compliant technology installed at our facility.”
“We were especially impressed with the detailed project management by the Bosch team. They not only planned every aspect carefully; they also implemented the project precisely”, Hussein concludes. “It was conducted in a very professional way. The short time frame combined with limited space capacities was a major challenge.”
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