Elkem Silicones Advanced Specialties Manufacturing

Elkem Silicones Advanced Specialties (ESAS) manufacturing facility was specifically designed and constructed to produce ultra-high purity silicone materials that meet the requirements of the MedTech and Pharma markets. The facility is dedicated to the production of Elkem’s Silbione™ Biomedical product range including medical grade liquid silicone rubber (LSR), high consistency rubber (HCR), silicone adhesives and dispersions. Elkem remains committed to providing best-in-class materials and services to life sciences industry leaders, enabling them to improve the lives of patients around the world.

• 18,000 square ft state-of-the-art manufacturing facilty with lab and warehouse space
• Class 7 and Class 8 clean rooms
• Quality Management systems meetings ISO 9001 and ISO 13485
• Follows IPEC and GMP standards
• Dedicated anayltical equipment for quality assurance
• Approximately 20 employees covering the functions in Quality, Regulatory, Engineering, and Manufacturing
• Elkem Silicones Advanced Specialties production site is dedicated to the production of high purity medical grade silicone material

Safety

• Toxicology management
• Procedural management
• Processes
• Safety/Training
• Product stewardship

Hygiene

• Industrial Hygiene Program
• Noise
• Chemical Exposure
• Health Monitoring
• Integral to product development and design

Environment

• Regular monitoring of key indicators
• Storm water, Haz,Waste

Quality

• Certification ISO 9001
• Certification ISO 13485
• Continuous Improvement EBS