AFC has a long history of successful production of highly potent compounds, including cytotoxic compounds. AFC maintains the required knowledge, experience, and facilities necessary to safely handle the commercial scale production of these compounds. Specialized process development and analytical capabilities for highly potent compounds are also maintained at AFC. We ensure that all potent compounds are handled safely by optimized process design, use of appropriate engineering controls, and adherence to strict administrative controls and procedures.
Occupation Health Categorization and Handling Practice Systems:
- Consistent sensitivity to people, ethics, and regulatory compliance while handling potent compounds
- Management of liability and productivity while handling highly potent compounds
- Systematic approach to classifying compounds and monitoring exposure situations
- Potent Compound Handling Programs specifically designed to ensure consistent controls and communication of risks
- Several isolated and independent facilities for the manufacture of highly potent compounds
Through three independent levels of control, our isolated and independent facilities have safely handled products with an Occupations Exposure Limit (OEL) as low as 0.5 µg/m3.
- Level One Control focuses on process design with an overall goal to avoid the exposure of the room and personnel to product
- Level Two Control focuses on engineering controls and facility design elements to isolate the room and personnel from the product
- Level Three Control focuses on procedures to ensure consistent communication, consistent processing procedures, monitoring for verification of containment, and appropriate use of personal protective equipment to protect against an equipment or procedure failure
In addition to the independent cGMP compliant manufacturing facilities for highly potent compounds, AFC maintains R&D laboratories designed and dedicated for high containment chemistry and a dedicated facility for the preparation and handling of highly potent compounds.