Product Transfer for Two New Industrial / Pharmaceutical Filter Assembly Line
The first challenges were to start-up and validate a newly designed corrugating machine for filters manufacturing. Product had tolerances and parameters which the machine needed to comply. Therefore and engineering study was developed in order to obtain the process capability of the machine. Once machine was up and running the parameters obtained during engineering study were validated during machine qualification. An Installation qualification and an Operational Qualification were performed.
This machine/process was followed by the packing machine which inserted the media between a core and a cage with a fixed amount of force. Once again in order to obtain the proper force to which filter media insertion needed to be, an engineering study was performed to obtain parameters, these were obtained by performing a DOE. These parameters were then qualified in an Installation/Operational Qualification.
Filters needed a top and bottom seal, which was performed in a machine that also required a DOE. Our personnel worked in conjunction with R&D and MDE in order to obtain the optimal parameters for these seals to be within specified product tolerances. These were then validated during and Installation and Operational Qualification.
Some tolerances required measurements which were given by a machine on which our personnel performed a Gage R&R to prove that this machine was capable of providing an accurate measurement with correct tolerances.
Finally filters were leak tested on a machine that also required a Gage R&R Nested and Crossed. After proving machines capability and passing the Gage R&R it was then validated during an Installation Qualification and an Operational Qualification.
Later a Process Qualification was performed for filter assembly. Batch and output also had parameters that required a Process Capability. All manufacturing requirements were met and all deadlines as well.
For Final Products, Plastic Welding was performed on a machine. Welding parameters were obtained during engineering study which required obtaining optimum temperatures, pressure and welding times. A DOE was performed to obtain such parameters. Later these were cross validated on additional two welding machines. Through a Hypothesis Test it was later determined that not all three machines behaved the same with the same parameters therefore additional DOE's were performed on each plastic welding machine. These parameters were then validated during an Installation / Operational Qualification (IOQ) for each of the three plastic welding machines.
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