In the pharmaceutical world, regulatory requirements are more and more time consuming, therefore companies need to invest into optimal solutions and processes.
Let’s take the example of the filter testing process from our consumer. The filters are used everywhere in the pharmaceutical production area: they are used for the sterilization of the product or for the protection of it (even exhaust). To ensure the filters efficiency, their integrity need to be tested before use. The results of these tests, evidence of the good GMP application must be linked to the batch report, consultable at any moment and understood by everyone.
These integrity tests take 20 minutes per run with an additional step of drying by oven of 13 hours for each filter.Everything is done manually by an operator (data encoding, test performing filter by filter etc.). This way of working is quite long and can be a source of mistakes, which does not ensure good data integrity.
That’s why RealDev has been contacted by one of the most famous belgian company in this sector.
The first challenge was to reduce the duration of the test and its drying. The team has designed a new skid and has manufactured it. This new design has several channels to test different filters at the same time and a compressed air inflow was installed for the drying step.
The second challenge was to update the software of the equipment in charge of the integrity test and make it fully automatized, user friendly and respectful of the data integrity rules. For these modifications the RealDev Team installed a PLC that pilots the new equipment designed by the team and implement the HMI. A barcode reader was also installed linked to a new software that communicates with a central database.
With this solution, RealDev produced added value by advising a new process approach and develop the appropriate solution. By taking care of the commissioning and validation, we did provide an end-to-end customer experience.
Realdev managed a cross-discipline project with IT, automation, mechanics and validation aspect and reached the target of our client. The duration of the test is still 20 minutes but 7 filters can be tested at the same time. The most signification improvement is the reduction of the drying duration which was reduced from 13 hours to 15 minutes.
Moreover, all the data are sent to the batch report automatically and the operator doesn’t need to encode manually any information of the filter anymore. The probability of making mistakes has radically decreased and GMP & data integrity are ensured.