Biomerics operates three controlled environment manufacturing rooms. Each room is dedicated to specific manufacturing processes and is designed to meet the corresponding quality and cleanliness standards.
3,500 square foot Salt Lake City clean room. This Class 100,000 registered clean room specializes in biomaterial polymerization, compounding, and injection molding operations. It is monitored monthly for particulate, and daily to assure cleanliness compliance. It has a controlled water system to manage bioburden during the pelletization process.
3,000 square foot Salt Lake City assembly room. This white room specializes in secondary operations and product assembly.
10,000 square foot Ashaway extrusion room. This white room specializes in extrusion, pad printing, tipping, and other secondary operations.
Each room is designed with a dedicated Hepa filter air handling systems, controlled water systems, side gowning facilities, and supporting gray room utility rooms. Biomerics has the clean room capabilities to meet both FDA's Medical Device Regulations 21 CFR Part 820 and ISO 13485:2003 quality requirements.