

Are you buried in the validation process?
ISO 13485 certified and FDA registered
What is Process Validation?
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.”
Validation Required?
- PTI will perform heightened inspection on initial product lots to reduce risk and fill pipeline after successful tool transfer.
- Heightened inspection will continue for each lot produced to mitigate risk until completion of IQ/OQ/PQ.
- Inspection of first shot, last shot, and in-process samples
- First Article Report – 3 or 5 pcs per lot (optional)
- PTI has a highly experienced validation team that will:
- Review historical validation records (if applicable) to ensure all original requirements are covered.
- Expedite protocols, inspection and validation reporting.
- Leverage our in-house metrology lab
- Our validation engineers complete over 100 tool validations per year and will ensure your path to success.
Advanced precision inspection and testing abilities
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.
Learn more about the Life Cycle of Validation and review our white papers on this topic:
Reducing the Life Cycle Cost of Validation: Part 1
Reducing the Life Cycle Cost of Validation: Part 2
Reducing the Life Cycle Cost of Validation: Part 3
Team PTI has been featured online in the Medical Product Outsourcing website. You can learn more about their role with Molding Validation Optimization – A Medtech Makers Q & A.
To learn more about our validation processes, plastic injection molding, or any of our other services, please contact us today.
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Design For Manufacturing Guide
Made in the USA

Mold Design
Mold Design is a crucial step in the injection molding process. Once you’ve finalized your part in CAD software for fit and function, it must then be transformed into a design for molding to ensure the capture of all the specified details. In some cases, certain features of the part design may not be manufacturable via the injection molding process.
At PTI, we collaborate with you to achieve the best possible design for manufacturability. In fact, we have a FREE guide to help you with this.

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