IRP MEDICAL
Capabilities · Secondary Operations

Secondary Operations

A molding supplier who ships parts and stops there hasn't finished the job — they've handed it to you. Every operation that happens after molding — cutting, finishing, inspecting, sterilizing, packaging — becomes another vendor for your team to source, qualify, audit, and manage. We finish what we mold, so those steps never land on your desk.

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Secondary Operations Hero Visual
Real-floor photography: precision-slit components, die-cut parts, or a packaging station in the secondary cleanroom.
ISO 13485:2016 Certified FDA Registered ISO Class 8 Cleanroom Environment Molding US Manufacturing — San Clemente, CA Since 1980
After the Molding

Every operation we absorb is one your team doesn't have to source, qualify, and manage.

This page is not a service list. It's an accounting of the vendors, purchase orders, and audit scope your program doesn't need when the molded part and the operations that follow it stay with one supplier. Each operation below sits downstream of the molding itself — liquid injection, compression rubber molding, overmolding / insert molding, and silicone extrusion — under the same roof and the same quality system as the engineering that started the program.

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Operations Lead Visual — Slit Component Examples
Real-floor photography of precision-slit components — the finished result of the slitting operation, alongside die-cut parts.

Precision Slitting

Molded stock isn't a finished component until it's slit — and a slitting operation is exactly the kind of small, specialized step that otherwise means a converting vendor your team has to find, qualify, and add to its audit calendar. Our precision slitting turns molded stock into finished, functional components — including slit valve geometries — in the same building where the part was molded.

Die Cutting

Gaskets, seals, and custom flat components cut from molded sheet stock usually mean a separate die-cutting house and one more quality handoff between molding and your receiving dock. We die cut in-house: the material, the cut, and the inspection stay inside one quality system, and the part arrives finished.

Deflashing

Compression rubber molding and transfer molding leave flash at the parting line — that's the physics of the process, not a defect of the supplier. The question is whose problem it becomes. If your molded parts arrive with flash, your team inherits a trimming operation and an incoming-inspection burden it never budgeted for. We deflash before shipment, so the part that arrives is the part on the print.

Complex Inspection

Some components defeat standard inspection — optically clear silicone, tight Critical-To-Function dimensions, geometries a caliper can't touch. Handing that problem back to the customer is the industry default. Instead, we engineer custom inspection solutions per program, so the verification burden stays on our side of the dock.

Inspection lives inside our quality system, not alongside it — see Quality for how it's built and defended.

Sterilization

Sterilization is one of the heaviest steps an OEM can carry: a specialized vendor to source, qualify, audit, and schedule, on top of everyone else. We take that step on. Sterilization is delivered through a qualified partner, stated plainly: we don't run a sterilization chamber, and we won't pretend to. What we do is manage the partner, the qualification, and the logistics, so a process as big as sterilization is one your team doesn't have to do.

Delivered through a qualified partner

Packaging

Packaging sounds like something that isn't a big deal — until your team has to spec it, source it, and validate it as a separate program. It's a very big deal precisely because it's another thing you don't have to do. Finished components are packaged in a cleanroom environment and arrive ready for your line, not ready for another vendor.

Sub-Assembly

Component-level sub-assembly — with the boundary drawn where it belongs.

A bonded overmold is already a sub-assembly: silicone molded onto a metal cannula or a plastic housing, validated as one component, from one supplier. We carry that further — joining and building molded components into component-level sub-assemblies, so what arrives at your line is ready for the next step in your process instead of a bag of pieces and a work instruction.

The boundary matters, so here it is plainly: we build sub-assemblies at the component level. We do not perform final device assembly. Building the finished device is contract-manufacturer territory, and IRP is not a contract manufacturer — we make the components and sub-assemblies your device can't function without, and we hand them off exactly where a component supplier should. Being precise about that line is part of why sourcing engineers trust the rest of this page.

Sub-assembly and packaging aren't an accommodation here — they run inside the same ISO 13485:2016 quality system as the molding floor.
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Sub-Assembly Examples
Bonded overmold sub-assemblies — silicone over a metal cannula, silicone over a plastic housing — and a multi-component build.
FAQ

Secondary operations, answered.

Does IRP do sub-assembly?

Yes — component-level sub-assembly, including bonded overmolds and multi-component builds joined from parts we mold. We do not perform final device assembly; sub-assemblies leave here ready for the next step in your process, not as finished devices.

Can IRP sterilize parts before shipment?

Yes. Sterilization is delivered through a qualified partner. We manage the partner and the logistics, so your team doesn't have to source, qualify, and audit a separate sterilization vendor.

Does IRP handle packaging?

Yes. Finished components are packaged in a cleanroom environment before shipment. Packaging is easy to dismiss until your team has to source and validate it separately — handled here, it's one more step that never lands on your desk.

What's included in secondary operations?

Precision slitting, die cutting, deflashing, complex inspection, component-level sub-assembly, packaging, and sterilization through a qualified partner. The molded part and the operations that follow it stay with one supplier.

Is IRP a contract manufacturer?

No. IRP is a custom component supplier: we mold silicone and rubber components and carry them through component-level sub-assembly, packaging, and sterilization coordination. We don't build finished devices and we don't perform final device assembly — that's the boundary between a component supplier and a contract manufacturer, and we stay on our side of it deliberately.

Quote the finished component — not just the molded part.

Slitting, die cutting, sub-assembly, packaging: tell us where your part needs to end up, and we'll quote the operations that get it there.

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