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Process Validation as defined by the FDA is “The collection and evaluation of data, from the process design stage throughout production, which establishes scientific evidence that a process is capable of consistently delivering quality products.” PTI’s advanced precision inspection and testing abilities address a spectrum of dimensional and functional product specifications and requirements.Our capabilities support comprehensive inspection actions ranging from receiving to final audit, as well as first article layouts, full AIAG PPAP and IQ, OQ, PQ Process Validation Submissions.To learn more about our validation processes, plastic injection molding, or any of our other services, please contact us today.Mold Qualification Tech Mold’s in-house mold qualification and process validation facility – Tech Mold East – means that our OEM customers get the production-ready molds they require to meet fast production start-up and time-to-market schedules.Tech Mold’s mold qualification division provides standard qualification (mold sampling) or advanced services, depending on your requirements.Staffed by experienced mold set-up technicians, and using state-of-the-art injection molding presses ranging from 40-400 tons clamping force, Tech Mold can ensure that your molds consistently make conforming parts shot-after-shot before the mold arrives on your production floor.Customer qualification requirements are reviewed with Tech Mold’s engineering and molding technicians prior to mold sampling.
Tech Mold’s experienced process technicians can establish optimum processing parameters, and provide process validation criteria per FDA or other specifications.
With the mold qualified and the process validated, we can then ship the mold or the mold/press combination to your facility or to your molder’s facility in ready-to-run condition.
Systems Integration The decision to use integrated automated systems in a manufacturing cell environment is critical to the ongoing success of the program.
At Tech Mold, we don’t just stop with the mold build.
We can design and develop Integrated Manufacturing Systems, working collaboratively with the top suppliers in the injection molding and automation industries.
Tech Mold offers Automated Manufacturing Cell Development & Validation, which is then shipped to your molding facility, optimized and production ready.