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