Pharmaceutical racking plant for pure space environment

On behalf a prominent Pharmakunden the Gerresheimer Medical plastic of system produced a complex medicine-technical product. Beyond the plastic-fair optimization, industrialization and manufacturing thereby by the Gerresheimer tool and automatic control engineering a pharmaceutical racking plant for the enterprise in the pure area of the ISO class 7 was conceived and built EN ISO 146441-1/EN. First, for studies and the clinical permission necessary test samples of the product were manufactured by Gerresheimer Regensburg. Subsequently, the misalignment and the structure took place with customer conception and development of the plant took place in close co-operation between the Gerresheimer Regensburg GmbH, the Gerresheimer tool and automatic control engineering as well as the customer. Since both the industrialization of the product and the development of the racking plant had to be realized under fastidious allowed time in the Simultaneous engineering, a detailed vote with the specialized divisions on customer side was indispensable. With the conception of the racking plant became the goods river, which and the air-lock technology of the pure areas considers existing transportation facilities. Additionally the pharmaceutical racking plant was coupled with the Blisteranlage downstream. Manfred Baumann, technical managing director of the Gerresheimer Regensburg GmbH, sees the vote of both plants as the largest challenge of the project: � the racking plant in the pure area of the ISO class 7 and the Blisteranlage in the pure area of the ISO class 8 are by an air-lock separate. Besides the cycle times of the two plants and the layer systems of the personnel on both sides of the air-lock are different. Here we developed a transportation concept, which solves this problem together with the HAW Amberg pastures. With the help of computer-aided simulation engineering we found buffer/stick solution, which makes a smooth sequential manufacturing possible. � the pharmaceutical racking plant corresponds to the requirements of the standard EN ISO 146441-1/EN ISO class 7th additional the standards of the Good Manufacturing Practice (GMP) and the Good automation Practice (GAMP) is kept. As a check of process risks with machines and plant extensive FMEA studies were accomplished. Data adminstration and data transmission take place via a special control engineering. The commercial filling will take place via the customer.

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