Concord, ON, May 14, 2021 – A recently completed expansion of Sterling Industries’ ISO Class 7 Clean Rooms enable the company to significantly increase its contract manufacturing capabilities for medical devices and sub-components.
The increased Clean Room space means the company can now undertake an increased range of specialized manufacturing activities: packaging (including Tyvek-sealed containers), ultrasonic welding, low-pressure molding, complex assembly and testing, and UV bonding and curing. These enhanced capabilities, optimized for the newly expanded Clean Rooms, are only the latest in a series of growth-related developments for Sterling, which announced it added a new manufacturing facility in the Toronto area in February. The enlarged Clean Room in Toronto resumed operating this month, and complements the company’s new Clean Room in Kalamazoo, Mich.
“Our expanded Class 7 Clean Rooms underscore our intent to grow our operations to meet accelerating demand from a broad range of medical device clients,” says Sterling Industries CEO David Van Slingerland. “Besides supporting our capacity to undertake specialized production activities, our expanded facilities and capabilities are part of a broader growth plan that includes hiring 50 or more new full-time manufacturing and engineering staff by 2022.”
A Clean Room is designed to maintain extremely low levels of particulates, such as dust, airborne organisms, or vaporized particles. An ISO Class 7 clean room is a specialized facility that uses HEPA filters to maintain air cleanliness levels of a maximum of 10,000 particles (≥0.5µm) per cubic foot. HEPA filtration systems must provide filter coverage of between 15 and 25 per cent and a minimum of 60 air changes per hour. The standard air flow rate for an ISO 7 filtration system is nine to 16 CFM per square foot.
About Sterling Industries
Established in 1984, Sterling Industries (sterlingindustries.com) provides end-to-end contract manufacturing and assembly of medical devices and components to Fortune 100 OEMs, as well as mid-size medical device OEMs and fast-growing “scale-ups.” Registered with the U.S. FDA and Health Canada, Sterling helps clients deliver successful products through its vertical integration, managing the entire process, including the supply chain, manufacturing, assembly, testing, labelling, packaging and shipping. The company operates from facilities in the Toronto area (Concord and Woodbridge) and Kalamazoo, Mich. Sterling manufactures success.
