Other Specialty Monomers & Custom Polymerizations
While glycolide and lactides are frequently employed in medical devices because of their versatility and proven track record, other starting monomers can be used as well. In addition to glycolide and lactides, Altasorb also offers other specialty monomers commonly used in the bioabsorbable material field. These include:
We also offer a line of custom manufactured reactive specialty fluoro-acrylates, methacrylates, and itaconate monomers in a variety of purities for use in polymer applications. Potential uses are:
Custom cGMP Manufacturing Services
Ortec can help you foster your product from early process scale-up through full production while maintaining confidentiality. We have the expertise to help you through process validations and qualification, and we've manufactured products under FDA Regulations CFR 210, 211, and 820. We constantly review new regulatory practices to ensure compliance.
Ortec has dedicated a 35,000 square foot, state-of-the-art facility to our cGMP manufacturing and related services. Located on 30 acres, this plant includes laboratories, pilot manufacturing suites and full-scale production areas. All chemical handling sections are designed as low particulate environments. Our 2,500 square foot clean room is validated to Class 100,000 (ISO 8) and contains USP Water for manufacturing use.
The laboratories contain several bench hoods for synthesis and development work as well as an assortment of instrumentation. There are also two isolated pilot and small-scale production lab suites. Each isolated suite contains two walk-in hoods supplied with steam, water, compressed air, and nitrogen.
Please contact us for your specific requirements.