Every supplier you're evaluating will show you an equipment list. Ours comes with a structural difference: one engineering team, one ISO 13485 quality system, and one molding floor that runs everything from a first article to full commercial volume. Molded in the USA, in San Clemente, California.
ISO 13485:2016 · BSI FM 590598/
FDA-Registered/
ISO Class 8 Cleanroom Environment Molding/
Made in the USA/
24/7 Operations
When a part fails in the field, the failure always traces back to one of the four. So that's how our capabilities are organized. We take ownership of all four, so you own none of them. The depth lives on each capability page; this page is the map.
Late-model LIM presses, fully automated work cells, robot demolding, in-mold vision systems, cleanroom environment molding, and 24/7 operations when the program demands it.
Molding & MaterialsClass 101 and Class 102 tooling stewardship end to end: mold design, DFM, cavitation strategy, vendor management, validation, and transfer.
Engineering & ManufacturingLSR from every major supplier, HCR gum silicone, EPDM, fluorosilicone, conductive grades, organic and synthetic rubber, and custom elastomer formulation to spec.
Molding & MaterialsValidated (IQ/OQ/PQ) using scientific molding methods, lean, and flashless where it matters.
Engineering & ManufacturingLiquid injection molding, gum molding, compression rubber molding, transfer molding, and flashless molding all run under one ISO 13485:2016 quality system. Certificate scope: “Custom Critical-To-Function Engineered Components.”
Your part arrives as a print. Between that print and a validated production cell sits the work that decides whether a program holds for years: technical sessions where our engineers deep-dive the design, manufacturability review that surfaces problems before steel is cut, and program management that carries the part from first article through full production. It's what separates IRP from the commodity shops below us, and from the contract manufacturers above us.
You own the component design. Our engineers make it moldable, measurable, and repeatable, recommending changes so the part can actually be made at your tolerances and volumes.
Technical sessions that deep-dive the design before tooling: geometry, material selection, cavitation strategy, and how every critical-to-function dimension will be measured.
Every step IRP absorbs, from tooling management and validation to sterilization coordination and packaging, is a step your team doesn't have to source, qualify, and manage.
These run side by side on one floor, under one quality system. No geometry gets forced into the wrong process, and no material gets chosen for our convenience.
Two-part liquid silicone rubber, metered, mixed, and injected into heated precision tooling, automated end to end for critical-to-function silicone components.
Where rubber is molded. Rubber isn't injected, it's compression molded: organic and synthetic rubber compounds, and larger silicone geometries, formed under heat and pressure.
Tighter dimensional control for multi-cavity work and molding around inserts, including flashless transfer tooling.
Silicone or rubber bonded to metal, plastic, or another silicone: one bonded, validated sub-assembly from one supplier.
High-consistency gum silicone for parts that need physical or chemical properties liquid silicone can't deliver, with compounds formulated to your spec.
Flash controlled at the source: tooling that molds the part clean instead of paying to deflash it downstream. In a medical device, flash is a contamination risk, not a cosmetic one.
A molded part often isn't a finished component. Cutting, converting, joining, and packaging usually mean another vendor, another PO, another quality handoff, and one more supplier inside your audit scope.
Every operation on this line is one your team doesn't have to source, qualify, and manage. The more steps we absorb, the fewer suppliers you carry, and the smaller your audit scope gets.
Precision slitting that turns molded stock into finished valves and components.
Components converted to final shape from molded sheet and stock.
Flash removed where the process can't eliminate it at the source.
Molded components joined and delivered as one validated sub-assembly.
Custom inspection solutions engineered per program, including vision processes for parts standard inspection can't see.
Coordinated through a qualified partner.
Device packaging, done where the part is molded.
Sub-assembly and packaging aren't an accommodation here. They run inside the same ISO 13485:2016 quality system as the molding floor.
Explore Secondary OperationsMost customers first buy a single part, a valve, a seal, a septum, and assume that's all we make. Custom silicone and rubber components from this floor run across every application area medical devices touch.
IRP sits in a specific place: above the commodity shops that take a print and ship parts, below the contract manufacturers that build entire devices. Here is exactly where the lines sit.
Send the PrintWhat we bring is design for manufacturability and mold design: technical sessions, manufacturability review, recommended changes so the part can actually be made, and the tooling engineered to make it.
We mold thermoplastic substrates in service of an elastomer component: the plastic half of an overmolded part, produced so both halves of the bond carry one accountable name.
If you're outsourcing the entire device, you need a contract manufacturer. We make the custom components the device can't function without, delivered as parts or sub-assemblies.
If the part is commodity rubber bought on price, we're not your molder, and we won't pretend to be. But if the part is small on the BOM and total on the function, send the print.
New program or supplier transfer,
it starts with the print.
From clinical builds to commercial scale, engage our engineers at the print.
Start Your ProgramRevalidation is a given. We plan it around your inventory bank, so your line keeps running while we qualify.
Transfer Your Program