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
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.
Multiple ISO Certifications
- Esschem embraces the practices and principles endorsed by the International Organization for Standardization (ISO).
- We hold both ISO 9001:2008 and ISO 13485:2003 certifications. The latter is not required for bulk suppliers, but Esschem chose to gain this certification as well to assist our customers whose products must comply with the Medical Device Directive of the European Common Market and require the CE mark.
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.