Why Cytotoxic APIs Need Special Handling
Due to their biological activity, cytotoxic APIs pose significant health risks if not properly contained during micronization and handling.
Jetpharma’s Expertise in Cytotoxic Micronization
We offer:
- Closed isolator systems for OEB5 handling
- HEPA filtration and negative pressure areas
- Glovebox operations for zero direct contact
- D10/D50/D90 precision control
Each process is backed by full GMP validation and cleaning procedures.
Regulatory Assurance for Oncology Product Development
All micronization steps are fully documented for FDA, EMA, and local regulatory inspections, facilitating smooth submissions.
Rely on Jetpharma for safe, validated cytotoxic API micronization.