Mold design validating how to
In the world of medical device manufacturing, the control over changes in manufacturing are restrictive, forcing manufacturers to prove that changes introduced to the process will not impact the design or performance of the device.While necessary to ensure patient and consumer safety, in the case of injection molding, these requirements are costly and create a significant strain on resources—both at the OEM and supplier level.The MOEMC focused on reproducing a consistent “end result” based on the transfer of a DC2 process via machine independent variables (MIV) and verification of what was happening in the cavity using technology, instead of machine inputs/settings for a defined process.The event took into consideration the applicable regulatory requirements outlined in 21 CFR part 820 as it relates to molded plastic components typically assembled into a finished device.The 1.4g part (drive clutch) was molded in an Acetal grade material.The mold that produced the part was a 16-cavity, direct valve gate, hot runner mold with an A-side lifter and B-side actions.Additionally, each cavity was equipped with force sensors to read plastic pressure.The additional data provided by technology increased confidence that the original validated process was being replicated in Trials 2 through 4.
The mold had flow meters and temperature sensors to monitor the water cooling circuits and temperature of the cavity/core steel.
The idea for the new approach for moving molds between machines was then reviewed with individual medical device OEMs over the next year.
That is also when the Consortium was proposed—to enable the OEM members to physically test the concept first hand.
Each OEM was required to have representation from quality or they could not attend; the perception that “it can’t be done” is the challenge the industry has to overcome.
The premise of the Consortium was to prove that Rod Groleau’s (founder of RJG Inc.) white paper, “Location Independent PPAP Streamlined for Global Manufacturing” (presented at the University of Michigan Automotive Conference in August 2000), could also apply to the medical device industry.