Cleanroom Injection Molding & Assembly

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.