Cleanroom Injection Molding & Assembly

About Cleanroom Injection Molding

Seaway Plastics maintains high standards and rigid certified quality assurance to ensure that our facilities meet all demands for cleanroom injection molding and assembly. The Seaway Advantage provides complete in-house injection molding services that protect the integrity of your product and reduce overall production costs. Between Seaway Plastics, Wright Engineered Plastics, and MME Group, we meet ISO Class 7 & 8 specifications for cleanroom injection molding processes. 

 

Both classes of ISO certification define the need to control the particulates and contaminants that can enter the room before, during, and after molding. To control contaminants, cleanrooms exchange air significantly more frequently than the 2 to 4 hourly cycles of a standard room. To remove contaminants and preserve a sterile environment, Class 8 cleanrooms exchange air ten to twenty-five times every hour, and Class 7 rooms cycle air thirty to sixty times in the same time. Our Class 7 cleanrooms are climate-controlled with special HEPA filters that remove airborne particles as small as 0.3 microns, and our Class 8 cleanrooms have filters that remove particles as small as 0.5 microns. The pharmaceutical industry, biotechnology companies, and other medical applications require sterile cleanroom injection molding environments to prevent any possible contamination. Specific products manufactured in these conditions can include surgical instruments, implantable medical devices, cardiac products, pediatric devices, dental products, and fluid delivery containers. 

All facilities meet the ISO 13485 certification standards required to manufacture most medical devices. This certification requires Seaway to demonstrate the ability to provide medical devices and services that consistently meet customer and regulatory requirements throughout the entire “life-cycle” of the product from development to storage and distribution. Our cleanrooms also meet the needs of businesses in other industries that require a sterile environment for the production of precision electronics, pharmaceutical packaging, and more.

Clean Room Molding Seaway

Cleanroom Injection Molding Machine Sizes & Capabilities

To meet our customers’ cleanroom injection molding needs for different size products and varying production volumes, our in-house cleanroom injection molding equipment ranges from 44 to 180-ton machines, and our capabilities include:

 

  • Silicone Injection Molding (LSR)
  • Low to high-volume production
  • Tight tolerances
  • Material and product traceability
  • Specialized packaging including sterile kit packaging
  • Vacuum system with deionized air blasting compliant with federal regulations
  • Vacuum bag sealer
  • Four-stage compressed air filtration system
  • Full range of value-added and post-production molding operations
  • Complete clean room kit assembly

 

From concept to delivery, our cleanroom injection molding certifications and standards maintain the integrity of your products to their final destination. Seaway Plastics Engineering, Wright Engineered Plastics, and MME Group have exclusive teams trained in cleanroom operating procedures, and we never compromise on safety or quality.

 

We provide a competitive advantage for our cleanroom molded plastics by getting involved with our customers early in the engineering phase and providing them with design for manufacturability, project management, in-house mold building, and support selecting materials.

Clean Room Molding

WIDE RANGE OF CERTIFICATIONS

An Outstanding Commitment to Quality

Ready to Discuss Your Injection Molding Project?