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Process Worldwide-02-2002

Flexibel for individual customer requirements
Qualification Solutions for the Secondary Packaging of Pharmaceutical Products


All component systems of a packaging line for pharmaceutical products must be validated and certified. The packaging company Gerhard Schubert not only offers customers in the pharmaceutical industry completely validated machines, but also, in cooperation with affiliated companies, undertakes the integration and validation of outside components for a complete production line.
There is a world of difference in qualification of primary and secondary packaging equipment!" least this was my opinion before I was hired by Gerhard Schubert to organize qualification department at his facility. the same time Schubert was involved in big project with Uhlmann for Wyeth Pharmaceuticals in Ireland. It consisted of complete blister packaging line where blisters, coming directly from a thermo former, were being transported into a Schubert SMB Wallet Machine where they were placed onto paper sleeves forming "wallets", which were then cartoned in a downstream machine. The requirements for the documentation and qualification of the Schubert machine were the same as the requirements for the thermo former. Code verification on blisters and sleeves, camera verification of placed blisters, counter control for all reject stations, etc. were just some of the GMP issues to be dealt with. Schubert not only delivered the required documentation and qualification on time, but also performed the qualification at Wyeth's site.


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