OUR CAPABILITES
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
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 & WHITE ROOM Assembly
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
Overmolding
ASSEMBLY & PACKAGING
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
3D-CAD DFM
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
Prototyping
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.
OUR PROCESS
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
Scope
Key Parameters Identified
Concept
Feasibility
Define Critical to Quality (CTQ) Characteristics
Special Process Identification
Sub-Tier Supplier Qualification (If Applicable)
New Product Integration (NPI)
New Product Development (NPD)
Qualification
Qualification
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 *
Tolerances
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
Validation
Validation
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
EXECUTION
Execution
Pre-Execution
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