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What We Do

From development to finished products, Gracon Manufacturing is here to support you in producing high-quality injection-molded plastic parts. From low volume production to larger projects, we deliver results and peace of mind at a competitive price. 


Injection Molding

Cleanroom Injection Molding

At Gracon Manufacturing, we offer cleanroom injection molding and assembly in our ISO Class 7 Cleanroom. We follow strict standard operating procedures (SOPs), including gowning procedures, work instructions, and quality records for cleaning and maintenance. Assembling components within a cleanroom environment offers consistency of quality. 

Traditional Injection molding

Our team gives you access to the right equipment to reliably make your parts. From 10-ton to 250-ton presses, our fleet of injection molding machines can make anything from 1 square inch to 1 square foot.


Cleanroom and White Room Assembly

We offer both cleanroom and white room assembly. Our dedicated assembly teams meet customer requirements and support small or large batch projects. We test to customer specifications and use customer designed testing equipment where required.

We care and clean our white room to the same SOP standards as our ISO 7 cleanroom.

Injection Molding


Cleanroom Production (ISO Class 7)

Non-Cleanroom Production 

White Room Assembly

Short Run Molding

Insert Molding




Product Assembly

Product Labeling

Product Packaging

Bulk Packaging

Secondary Operations


Ultrasonic Welding

In Mold Labeling (IML)

Pad Printing/Hot Stamping

Part Labeling

Product Development

Product Development

We understand the importance of the design and development of your product. Design impacts quality, reliability, functionality, and manufacturability. In addition, 80% of plastic injection molded parts’ cost is determined by design.

If you are ready for product development, our team will assist and make recommendations for your designs and materials to reduce production and secondary service costs. 

Our Product Development Services include:


Rapid Prototyping

Benchmarking of Products and Materials in Different Models


Pilot Production

Process Validation

Scalable Tool Designs and Optimization for Volume Production

Support From Our Third-Party Partners for Regulatory Requirements Such As Accelerated Aging Tests, Biocompatibility Tests, Packaging, and Transportation Simulation, Sterilization Validation, etc

Support and Creation of Documentation As Needed per Applicable Regulatory Standards

Reverse Engineering

Design for Manufacturing



Prototyping is a critical part of the design and development process. We leverage 3D additive manufacturing to expedite this process and reduce costs. After design drawings are approved, we create physical prototypes to physically test and evaluate the design concept from a fit, form, and function standpoint and make sure everything works as intended.  

Our rapid prototyping can accelerate your time-to-market and avoid unnecessary costs and delays in production. The complexity of your part, the surface quality, quantity needed, and time or costs restraints are all considered when designing and testing a prototype before going to market. 

Prototype Tooling

Prototype Tooling

We leverage 3D additive manufacturing to expedite the process and reduce costs for molding prototypes.  We evaluate program requirements and timelines, allowing us manufacturing options from the use of custom 3d printed and aluminum insert plates along with standard base and top plates through full-hardened steel tooling to accommodate your medical or rapid prototyping goals.

When you are ready to transition to production, our network of highly skilled mold makers has the knowledge, experience, and equipment to produce and maintain molds across classifications. We partner with our customers to streamline the development process and allow you to be only as involved as you need or want to be.



How We Work

Our process begins with understanding your needs. This includes all quality requirements, documentation, and support with any regulatory responsibilities. We have a proven record of meeting these expectations and quickly adapting when needs or conditions change.

Customer Needs

Customer Needs

Whether our team is helping you transform an idea into a reality or transferring a tool to our production facility, your needs guide our path forward. 

Contract Review

Project Timeline Evaluation

Risk Management Plan

Quality Requirements


Key Parameters Identified



Define Critical to Quality (CTQ) Characteristics

Special Process Identification

Sub-Tier Supplier Qualification (If Applicable)

New Product Integration (NPI)

New Product Development (NPD)



Prototype Meets Intended Form Fit Function

Testing Preformed

Mold Flow Analysis

Tranfer Tool Qualification

Supply Chain

Opportunity to Look For Cost Savings

Satisfies All Applicable Regulatory Requirements *


Sustainability Review

Design Failure Mode Effects Analysis (DFMEA)

Production PLANNING

Production Planning

Production Part Approval Process (PAPP)

Process Flow Chart (Including Assembly, Conveying, Packaging if Applicable)

Process Control Plan

Quality Management Plan

Design of Experiments (DOE)

Measurement System Analysis

Sampling Inspection (If Applicable)

CAPA Planing

Supply Chain Risk Management

- Final selection of pre-qualified suppliers
- Secondary suppliers will be used for high-risk/critical



Production Part Approval Process (PAPP)

Special Process Validation Approval

Process Failure Mode Effects Analysis Diagram (pFMEA)

Process Capability Performance Study (CpK)

Lot Traceability Plan

Finalize Process Parameters

Process Validation (IQ, OQ, PQ)

Production Process Meets QC Objectives and AQL (Accepted Quality Level)

First Article Layout (FAL) Inspection Submission




Production Process Controls

Work Instructions Finalized

Travelers Created

Installation, Inspection, and Testing Instructions

Acceptance Processes (Incoming, In-process, Final Acceptance)

Production Record Retention (Quality and Device History Records)

First Order Manufactured and Fullfilled

Continual Improvement

Continual Improvement

Plan, Do, Check, Act

Preventative Action Corrective Action (PACA)

Corrective Action Preventative Action (CAPA)

CAPA Trend Analysis

Customer Feedback of Performance in the Market

Supply Chain Reviews

Statistical Process Control (SPC)

Change Management

- Continuous improvement efforts to manage cost, quality, delivery, and technology.

Non-Conforming Product Monitoring

- Non-conforming product is replaced free of charge.

Management Review

Let's Work Together

We want to understand your business and needs to deliver the best solutions. Get in touch to discuss your project or reach out with questions, requests, or more information about our capabilities.


130 Miners Drive
Lafayette, CO 80026

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