FROM CONCEPT TO
FINISHED PRODUCT.
Custom injection molding for medical and industrial OEMs. Two ISO 9001-certified U.S. facilities run under one quality system, with Class 8 cleanroom molding at both. New programs and transferred tools both start with a documented review, and traceability begins at the first shots off the tool. The engineers who review your part for DFM stay with the program through production.
One quality system.
Five markets.
Medical component programs and industrial production run in the same buildings, on the same quality system, with the same engineering team. Start with the market that matches your program.
The right people at the right stage.
A CAD model never flashes. Gate locations, wall sections, and resin choice get challenged before steel is cut, by the person who will stand at the press when the tool runs. That is the cheapest hour in the program.
Engineering capabilities
Prototype speed.
Production confidence.
Design validation on printed parts is validation of the wrong process. Incepta Tooling puts steel bridge tooling under your part in 4 to 6 weeks, running your production-intent resin, so pilot builds, design validation, and early launch volumes happen on real process data.
Explore Incepta ToolingEvery part, documented.
We maintain traceability beginning with the first shots produced from new tools, as well as transfer tools, and continue this traceability through all subsequent production lots. Each production lot is documented and controlled to ensure that the material and finished product can be traced back through the manufacturing process.
Traceability
01All materials and products are identified by lot and maintained within our quality system. A Certificate of Analysis (COA) is provided to the customer with each applicable lot to document the material specifications and support complete material traceability.
Validation support
02IQ/OQ/PQ execution support, PPAP, and First Article on programs that require it. We support your validation. We do not own your regulatory approval.
Change control
03As an ISO 9001 certified company, we maintain a controlled change notification process to ensure that our customers are informed of any changes that may affect the materials, tooling, manufacturing process, or final product.
Material control
04We maintain a controlled material management and traceability system for all manufacturing materials, from industrial-grade resins to Class VI medical-grade materials. Material lots are tracked from receipt through finished production, with certificates and supporting documentation available upon request, subject to applicable confidentiality or contractual requirements.
Full sourcing disclosure available during qualification, under NDA.
The quality systemYour program
always has
a path.
Two U.S. facilities under one ISO 9001 quality system, about 1,000 miles apart. If a schedule is at risk at one site, the program has somewhere to go: the same certified standard, the same documentation, the same color specs, and the same engineering team. No new supplier, no requalification.
Continuity is planned before you need it.
Our facilitiesPittsfield, MA and Ormond Beach, FL. About 1,000 miles apart. More production flexibility. Programs can be matched with the location, equipment, and capabilities that best fit the project.
The same ISO 9001-certified standard governs every run at either site.
The same engineers on your program at either site. No handoff, no relearning the part.
Programs we run.
Representative part families. Customer devices and products stay under NDA.
“As a result of the supplier evaluation performed in September 2019, your company was given an overall score of 100 out of 100. With this result, you are one of the top-performing suppliers. The purpose of this communication is to inform you of your rating and to say Thank You for the excellent performance. As a result of your ongoing strong performance, your Company will be a preferred option for potential new business in the future.”
How a program starts.
Five steps between the first call and the first production run. No configurator, no instant price. We protect your intellectual property and review your program before providing a quote.
Conversation
Tell us the part, the volumes, and where the program stands. Sales and engineering are both on the first call, so commercial answers and technical answers come out of the same conversation.
NDA
Executed before drawings change hands. Your paper or ours.
Engineering review
Moldability, gate and wall feedback, resin recommendation, and the risks we would flag before anyone quotes a number.
Tooling path
We walk the options before steel is committed. Whether you need Incepta Tooling for validation and early production, a long-term production mold, or a combination of both, we match the tooling investment to your timing, volumes, and program goals.
Qualification and production
Tool qualified in our toolroom, then documented process control on every run, in either facility.
Have a Plastic Project to Review?.
Send us your part files and program requirements. Our team will review the design, recommend the right tooling and molding approach, and provide a clear path to quotation.
