After investigating the user requirements specification, we started a couple of years ago on a project that became a great success with in the end a very satisfied customer. The specification described the requirements for a combined assembly and packing line to assemble and pack a pharmaceutical product inhaler. Within the package a desiccant sachet had to be included.
We could fulfil the URS with available standard modules. With our experience in auto-feeding sachets onto running products we delivered our modular product infeed system, type RT-48 with an automatic sachet feeder. The sachets, which are supplied in one large string, are cut and fed on top of the running inhalers. The inhalers with sachets are then wrapped in a hermetic sealed wrap approved by the flowpack machine.
After translating the URS into a traceability matrix we had an overview of what we had to implement extra into our special pharmaceutical software platform, what kind of tests had to be created and what had to be documented as evidence. With our internally trained personnel, who were then qualified to work on this project, we started engineering after approval was given in the first periodic project review.
Our modular built software, according to IEC61131, is written in line with GAMP requirements. Thanks to this modular designed software and well qualified engineers, we were able to create the total customized package very easily.
During the project we built together with the customer the final Qualification Documentation Package. The complete package documented the evidence on how the equipment was designed, that all key aspects of the hardware and software installation adhered to appropriate codes and approved design intentions and that the equipment-related system or subsystem performed as specified throughout representative or anticipated operating ranges. The testing specifications verify the design and function specifications and the requirements of the user. In the end, in good collaboration with the customer, we delivered a customized documented evidence package that fulfilled all user requirements.
After a successful factory acceptance test (FAT) with the customer, the equipment was shipped to the customer’s premises ready for a site acceptance test (SAT). With help from our qualified field service engineers, the customer preformed his SAT successfully.
This project has been successful for both parties. It has reinforced trust and it has lead to two identical orders for this packing line up till now.
Startpage Bosch.de
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