Orthopedics - Bone Cement

Orthopedics – Bone Cement

Esschem, the most trusted source for high-grade acrylics for dental, cosmetic, and biomedical applications has a 30-year record of accomplishment as well in the production of polymer substrates and monomers for bone cement systems.

Key compounds produced by Esschem in this area include:

  • Polymethylmethacrylate (PMMA) homopolymer
  • MMA/Styrene copolymers
  • MMA/Methyl Acrylate copolymers
  • Precisely formed monomers

 

Consistent Quality:
Purity and Batch-to-Batch Consistency Set Us Apart

  • We use computer-controlled reactions and special sifters to produce polymers of precise particle size.
  • Esschem accurately controls the addition of benzoyl peroxide or other catalysts and/or radio-opaque materials such as barium sulfate.
  • Monomers are shipped in dedicated stainless steel drums to assure purity in transit.
  • State-of-the-art technology and strict adherence to the most stringent quality standards are a given at Esschem.

 

ISO Certification

  • Esschem embraces the practices and principles endorsed by the International Organization for Standardization (ISO).
  • We hold certification to ISO 13485:2016. Esschem chose to gain this certification to assist our customers whose products must comply with the Medical Device industry regulations.
  • Esschem has successfully achieved ISO 13485 certification for 25 years.

 

Esschem ISO 13485 Certificate

 

Full QC Analysis of Every Batch

  • Esschem’s bone cement production facility has been FDA-inspected and is available for regulatory and/or customer inspection
  • Each batch undergoes a full quality control analysis before shipping.
  • Certificate of Analysis documents the findings and is sent with every order.
  • We archive a product sample with the production records for traceability during the entire life of the medical device.