Enhanced Quality
Qualified implementation of OptiworX to standardize manual processes for format changeovers in an inhaler filling isolator for one of the world’s 20 leading pharmaceuticals companies, headquartered in Germany.
The Situation
Pharmaceutical manufacturing and packaging activities, particularly production and filling processes under clean room conditions, require strictly regulated conditions according to GMP. As is required in regulated areas, the filling line needs to meet the highest quality and safety standards. This automatically implies that there is no margin for error in manual processes such as refitting the line. Any process deviation would shut down the system.
The Solution
After the implementation, which fulfilled the client's high requirements for pharmaceutical processes, OptiworX ensured that the validated SOPs (standard operating procedures) are now followed in any shift, by any employee.
In this implementation, existing standards are supported by OptiworX so each employee, whether newer worker or supervisor, is keeping the standard procedure for any task. In this way, lesser trained workers in particular, obtained greater security and were more motivated in performing the approved procedures. Furthermore, time for supervision of lesser skilled could be reduced.
Next steps
After the implementation in the primary inhaler filling isolator was successfully completed, OptiworX has now also been expanded into the secondary packaging areas.