

Quality parts start with our premium in-house tooling department.
ISO 13485 certified and FDA registered
Plastic Injection Molding for Medical Devices
PTI Engineered Plastics is an industry 4.0 supplier, providing medical device manufacturers the advanced product development that they demand, more quickly and efficiently than ever before.
Having served the medical industry for over 40 years, we’ve perfected medical device manufacturing. By pushing the technology of Plastic Injection Molding, it remains a top manufacturing method for precision and cost-efficiency.
Utilizing injection molding allows medical design engineers the freedom to design complex parts in a variety of materials. The consistency of the plastic injection molding process is ideal for both low and high volumes production, setting your medical device up for immediate success.

Tool Makers
Complex tooling and molds are where we specialize
Materials
At PTI, we use an array of materials from aluminum, mild steel, hardened steels, stainless and copper beryllium to create prototypes, low volume, hybrid and production tooling
Mold Bases
SPI CLASSIFICATIONS
101, 102, 103, and 104.
Runner Systems
Cold runner.
Hot drop and hot manifold systems with valve gate options.
Keys to Success
Made in the USA

Mold Design
Our competent designers know what questions to ask by providing design recommendations, viable alternatives and practical assistance to assure that the customer’s requested part design or model meets their specifications. Part design is never sacrificed to fit a simple one-size-fits-all mold build concept. Each customer has their own list of unique requirements, and it is the goal of PTI to continually meet or exceed those requirements in molding design.
Bad Designs Can Cost You!
The advantage of good designers will save you thousands of dollars by eliminating quality issues and long cycle times. Often plastic parts are not designed with a manufacturing mindset. With 30+years design experiences our skilled designers recognize what it takes to deliver a design capable of producing a quality part.

Tool Makers
Let Us Manage Your Tool Transfer
When your current manufacturer is unable to continue production or supply final molded parts, transferring a tool or mold can rescue a company from losing precious production time and quality.
During the process of transferring your tool to our molding facility, we’ll conduct a thorough evaluation of the tool to establish a proactive maintenance program, all while maintaining smooth production operations. Our in-house tooling team will promptly address any necessary repairs and swiftly return the mold back into production to minimize downtime. Additionally, regular preventative maintenance will be carried out more efficiently throughout the production process.
Our Tool Making Is a Cut Above the Rest

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 will be conducted, with 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 and leverage our in-house metrology lab, where our validation engineers complete over 100 tool validations per year to ensure your path to success.

IQ OQ PQ Validation
Process Validation
In many cases, our medical device customers look to process validation to ensure quality parts. After all, patients lives depend on PTI to deliver high quality parts each and every time.
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.”
Process validation is the best way to ensure the production of safe parts, to reduce rejection rates, to prevent part failures in the field and to ensure the part meets with application, specification and regulatory obligations.
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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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