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Pharmaceutical Processing News
News Release from: Werum Software and Systems | Subject: Werum PAS-X
Edited by the Processingtalk Editorial
Team on 02 March 2005
Pharmaceuticals facility uses PAS-X MES
The infusion solutions produced at the B Braun Melsungen pharmaceuticals facility are manufactured by means of a highly automated process in a validated production environment, using Werum PAS-X
The German MES specialist Werum Software and Systems completed the installation of its Manufacturing Execution System (MES) PAS-X in the new pharmaceuticals facility of B Braun Melsungen AG at the end of 2004 In August 2002 B Braun began building a new facility in Melsungen, Germany
This article was originally published on Processingtalk on 13 Jul 2006 at 8.00am (UK)
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The project is referred to as LIFE (Leading Infusion Factory Europe).
After its official inauguration scheduled for April this year, LIFE will be Europe's largest factory producing infusion solutions.
The plant has been designed under consideration of the latest achievements in work organization, pharma technology, IT and logistics.
The project volume for the new facility is the largest investment in B Braun's history.
Within the overall IT concept of the factory PAS-X is the central system to coordinate the ERP system SAP R/3, the various process control systems on shop floor level and the system controlling the material transport technology.
The infusion solutions are manufactured by means of a highly automated process in a validated production environment.
Using the electronic batch recording functions provided by PAS-X B.
Braun has achieved a paperless and GMP-compliant documentation of the manufacturing process.
Apart from archiving of the raw data according to 21 CFR Part 11 requirements, the system also archives the operating data delivered by the production equipment and places them available for analysis.
On this basis the system enables a complete electronic batch tracing, which is available at the click of a button.
Manufacturing is started up in several steps; the first production line became operational in October 2004, two more lines will follow in April.
The produced Ecoflac plus PE bottles contain infusion solutions which are delivered to hospitals as mass product.
On the three production lines up to 150 mn.
infusion bottles in sizes of 100, 500 and 1000 milliliters will be produced each year for the world market.
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