Our technical staff makes project transitions seamless across our North American and European footprint. Our expertise enables us to scale up your process, and we’ll be there for you every step of the way. We also ensure that your work is held in the highest confidentiality.
In highly regulated markets, it is critical to have chemical manufacturing and research partners who understand the breadth of requirements to meet your needs.
HOW CAN
ORTEC HELP?
Ortec can help you foster your product from development to early process scale-up through full production while maintaining a high level of confidentiality. We have the expertise to help you through process validations and qualifications, and we’ve manufactured products under FDA regulations CFR 210, 211, and 820. We constantly review new regulatory practices to ensure compliance. Ortec has two cGMP-dedicated state-of-the-art facilities in our cGMP manufacturing and related services portfolio. Located on 45 acres, our Piedmont facility is 85,000 sq. ft. and includes laboratories, pilot manufacturing suites and full-scale production areas. Our Newcastle West, Ireland facility is 26,000 sq. ft. All chemical handling sections are designed as low particulate environments with 95% filtered air. Our Piedmont, SC facility includes three ISO 8 clean rooms, with one containing USP water and UV-filtered lights and windows and our Newcastle West, Ireland facility includes two ISO 8 clean rooms with USP water and two cGMP blending rooms.
The innovative work our PhDs and chemists produce continues to expand the range of chemistry capabilities we can offer, such as:
- Free Radical Polymerizations for Emulsions and Solutions
- Condensation Reactions and Polymerizations
- Acrylic Urethane and Silicone Polymers
- Monomer Design
- Extraction and Purification processes
- Blending Operations with organic solvents and USP-grade water
At Ortec, we realize it is not what we can do, but how we do it that makes a difference for our customers. For more detail on our capabilities, please click on the links below.
HOW CAN ORTEC HELP YOU?
Are you considering outsourcing your chemical manufacturing? Want to free up your assets to focus on other projects? Need a partner who has the quality systems and regulatory knowledge to meet your demands? Someone who can hit specs, improve efficiencies, and get you quickly to market without going over budget?