Capabilities.
Cleanroom molding, white room production, tooling, assembly, metrology, and program management under one roof in Ontario, California.
Cleanroom Manufacturing
Our cleanroom operation is the core of the business: more than 40,000 square feet of ISO Class 8 and Class 7 certified manufacturing space purpose-built for medical device, biopharmaceutical, and diagnostics production. Molding, assembly, and packaging take place in controlled environments with documented monitoring and validated processes.
- ISO Class 8 and Class 7 certified cleanrooms
- 40,000+ sq ft of cleanroom manufacturing space
- Cleanroom molding, assembly, and packaging
- Dedicated post-molding operations areas in ISO Class 8 and Class 7 environments
- 24/7 production from small scale to mass production
White Room Manufacturing
For components that require a controlled environment without full cleanroom classification, our 7,000 square foot white room provides a cost-effective production path with defined cleanliness and handling protocols.
- 7,000 sq ft of controlled white room space
- Defined cleanliness and handling protocols
- Cost-effective path for components with cleanliness requirements
Precision Injection Molding
More than 80 injection molding machines ranging from 20 to 350 tons give us the flexibility to run everything from micro-scale precision components to larger structural parts, at volumes from pilot builds to full-scale production. Our molding teams include RJG Certified Master Molders running scientific molding processes with in-cavity process monitoring, supported by an Operational Excellence team driving metrics-based continuous improvement.
- 80+ injection molding machines
- 20 to 350 ton clamping range
- Over molding and insert molding
- Multiple high-cavitation molds running cycles under 6 seconds
- RJG Certified Master Molders and scientific molding practices
Tooling & Engineering
Our in-house tooling, process, and automation teams support programs from initial design through validation and ongoing production. With decades of tool building experience on site and a fully staffed toolroom, we control quality and lead time at the point where most molding programs succeed or fail: the tool. In-house tool designers experienced in design for manufacturability work alongside established relationships with leading tool suppliers, with in-house mold flow analysis validating every design before steel is cut.
- Fully staffed toolroom: in-house mold makers, mold repair specialists, and polishers
- Management of new tool builds, domestic and overseas
- CNC mills, sinker EDMs, lathes, and precision surface grinders
- SolidWorks and Mastercam design environment
- In-house mold flow analysis and DfM support
- Individual tool maintenance strategies with updated spare-part catalogs to protect production continuity
Assembly & Secondary Operations
Beyond molding, we offer customized, flexible assembly options that scale with each project phase, from manual benches through fully automatic assembly lines. A dedicated post-molding operations area handles manual assembly and ultrasonic welding, and our design for assembly expertise ensures robust, repeatable manufacturing processes.
- Manual, semi-automatic, and fully automatic sub-assembly
- Ultrasonic welding, pad printing, and UV printing
- Complex high-speed cavity separation and part inspection
- Design for assembly (DfA) expertise
Program Management
Every program is led by a dedicated program manager who serves as the single point of contact from kickoff through commercial production.
Quality & Metrology
The principle of continuous improvement is embedded within our certified quality management system. Onsite quality engineering, quality control, and quality assurance teams support customer validation, production, and quality needs, with in-house metrology labs in both cleanroom and white room environments equipped with coordinate measuring machines (CMM) for highly efficient data acquisition. Our teams are experienced in maintaining device master records for specifications, production processes, quality assurance, and packaging, and a professional regulatory affairs function supports customer regulatory paths under MDR and IVDR.
- ISO 13485:2016
- ISO 9001:2015
Tell us about your program.
Whether you're scoping a new medical device launch or transferring an existing tool, our engineering team is ready to help you evaluate cleanroom options, validation strategy, and production capacity.
Tell us about your program.
Whether you're scoping a new medical device launch or transferring an existing tool, our engineering team is ready to help you evaluate cleanroom options, validation strategy, and production capacity.