Introduction:
Manufacturing cytotoxic APIs involves working with substances that can be hazardous even in microgram quantities. Effective containment is not just a regulatory requirement it’s a moral responsibility.
Key Points:
- OEB Classification: Cytotoxic APIs often fall into OEB4 or OEB5, requiring specialized containment systems like isolators and glove boxes.
- Facility Design: Negative-pressure cleanrooms, unidirectional personnel/material flow, and HEPA-filtered HVAC systems prevent contamination.
- Operator Safety: Personal protective equipment (PPE) is essential, but engineering controls take priority in minimizing exposure risk.
- Depth Medicare’s Measures: Our facility integrates sealed process equipment, air jet mills with closed transfer systems, and validated cleaning protocols for cross-contamination prevention.
Closing Thought:
Containment is the backbone of cytotoxic API production ensuring product purity, operator safety, and environmental protection simultaneously.
