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.
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.
