ISO Class 8 and Class 7 Cleanroom Manufacturing.
Precision cleanroom injection molding for medical device, biopharmaceutical, and diagnostics manufacturers.
Balda C. Brewer operates one of Southern California's largest cleanroom injection molding facilities, serving regulated customers across the Americas and Europe from Ontario, California.
Scale that meets the demands of regulated manufacturing.
Six decades of investment in capacity, controlled environments, and process discipline quantified.
Balda C. Brewer Is Now Part of Craftech Holdings
Balda C. Brewer is now part of Craftech Holdings, joining a precision injection molding platform with facilities in Ontario, Anaheim, and Tijuana. The combined platform offers customers ISO Class 8 and Class 7 cleanroom production in the US and a nearshore cost option under a single commercial relationship. Our team, our programs, and our commitment to regulated manufacturing continue without interruption.
Built for regulated
manufacturing.
Medical device, biopharmaceutical, and diagnostics products demand more than standard injection molding. They demand controlled environments, validated processes, and a team that understands what is at stake in every part. Balda C. Brewer has spent over six decades building exactly that capability, and today operates more than 40,000 square feet of ISO Class 8 and Class 7 cleanroom manufacturing space dedicated to regulated markets.
- Controlled ISO Class 8 & 7 environments
- Validated molding processes & IQ/OQ/PQ
- In-house metrology and quality engineering
- Over six decades of regulated program experience
Six integrated capabilities.
One accountable partner.
From cleanroom construction to validated production, every step of your program lives under one roof and one quality system.
Cleanroom Manufacturing
40,000+ sq ft of ISO Class 8 & 7 certified molding and assembly space.
White Room Manufacturing
7,000 sq ft of controlled white room production for defined cleanliness requirements.
Precision Injection Molding
80+ molding machines from 20 to 350 tons, engineered for tight-tolerance, high-volume production.
Tooling & Engineering
In-house toolroom with mold design, mold flow, and maintenance supporting design through validation.
Assembly & Secondary Ops
Manual, semi-automatic, and fully automatic sub-assembly, plus ultrasonic welding, pad/UV printing, and over/insert molding.
Quality & Metrology
In-house metrology labs with CMM and state-of-the-art Keyence measuring equipment and onsite quality engineering supporting validation through production.
A controlled path from first article to full production.
Talk to engineering →Program Scoping
Define tolerances, regulatory class, volumes, and cleanliness targets with your engineering team.
Tool Design & DFM
In-house mold flow, DFM review, and tool build plans aligned to your validation strategy.
Validation
IQ / OQ / PQ protocols executed in our Class 7 and Class 8 cleanrooms.
Production
Controlled, monitored production with statistical process control and lot traceability.
Precision for the industries that can't afford to compromise.
Medical Device
Engineered components and assemblies for devices where precision and repeatability are non-negotiable.
- Engineered components and assemblies
- Precision and repeatability for regulated production
- Validated sub-assemblies
Biopharmaceutical
Cleanroom-molded products supporting drug delivery systems and pharmaceutical manufacturing.
- Drug delivery devices
- Cleanroom-molded pharmaceutical components
- Process consumables
Diagnostics
High-volume precision parts for in-vitro diagnostics and laboratory platforms.
- Lab automation trays
- High-volume precision parts
- Microfluidic components
Part of the Craftech Holdings platform.
Balda C. Brewer and Craftech are part of Craftech Holdings, a precision injection molding platform with facilities in Ontario, Anaheim, and Tijuana, Mexico.
Together, the platform offers customers US-based cleanroom production and a nearshore cost option under a single commercial relationship, with more than 250,000 square feet of combined manufacturing space across the United States and Mexico, including over 60,000 square feet of cleanroom capability.
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.
Start your next program with us.
From first article to full production, our team is ready to discuss your requirements.