Hazardous chemistry- from process development to large scale production
Hazardous chemistry- from process development to large scale production
Hazardous chemistry, involving the use of highly energetic reactions and/or hazardous reagents, is a key technology in the process development toolbox, with potential to improve process cycle time, purity & yield, reducing both operational costs and environmental impact. Its use is well established for the commercial synthesis of APIs & intermediates, and offered by specialist CDMOs such as Novasep, with a strong safety culture & benefitting from decades of expertise.
In some cases, the innovative use of hazardous chemistry can contribute to a significant reduction in the number of synthesis steps. The amount of impurities and by-product generated may also be limited leading to cost-effective syntheses affording the targeted compound in high yields.
A recognized expertise in hazardous chemistry
Novasep is a world leader in the production of hazardous compounds. We have a proven track-record in developing and manufacturing APIs using hazardous chemistry:
Over 35 years of experience in commercial manufacturing
- Manufacture of APIs & cGMP intermediates using hazardous chemistry
- More than 20 APIs produced every year
Outstanding quality assurance track record
- Facilities inspected by the US FDA, National Health Authorities (EU) and PMDA (Japan) accredited: download our brochure about to learn more!
Depth of HSE culture & know-how
- Deeply ingrained safety culture
- Excellent HSE track record
- Methodology for risk analysis
- On-site safety testing
- Authorisation for explosives manufacture on our
Expertise in hazardous chemistry legislation
- Hazard evaluation and knowledge of regulations
- Reports accepted by authorities (REACH BAM, BZR)
- Ability to offer regulatory support to our customers
Support for freight & logistics of dangerous goods
- Dangerous goods classifications
- Expertise and support with transport
Strength of hazardous chemistry process development
- Process development expertise with a wide range of highly energetic reactions and compounds
- Wide experience with process scale-up, validation & commercial production at a wide range of scales
Flexible and collaborative approach
- Experienced Project Managers
- Reactive to changes in customer needs
Our specific know-how in hazardous chemistry
We have specific expertise in handling:
- Explosive compounds
- Shock & friction sensitive chemicals such as
- Self-igniting gases and liquids
- Thermally sensitive compounds
- Toxic materials
- Highly exothermic reactions
We are experienced in highly hazardous chemistry such as:
Our expertise also includes:
- Alkyllithium handling
- Hydroxylamine chemistry
- Sodium metal handling
- Lithium aluminium hydride (and other hydrides) handling
- Highly exothermic reactions
- The handling of explosive compounds
- The handling of highly toxic materials and thermally/mechanically unstable
