High Potent APIs are becoming increasingly important in pharmaceutical development, with a growing market, particularly in oncology, immunotherapy, and hormonal treatments, due to their effectiveness in small doses. These compounds, while therapeutically powerful, pose significant risks during manufacturing due to their toxicity and potential to cause harm at low exposure levels.
Mitigating the risks of handling high potent APIs in pharmaceutical facilities requires stringent safety protocols, such as:
- Containment systems like isolators, closed processes, or closed transfer systems to minimize exposure.
- Engineering controls including proper ventilation and high-efficiency particulate air (HEPA) filtration.
- Personal protective equipment (PPE) for workers, combined with regular training and monitoring to ensure safe handling.
- Dedicated production areas to prevent cross-contamination with other products.
By implementing these safety measures, pharmaceutical facilities can protect workers and maintain product integrity while handling high potent APIs, ensuring both operational safety and regulatory compliance.
At Glatt Pharmaceutical Services, we mitigate these risks by using an OEL-OEB calculator, Decontamination Airlocks, Closed processes, Mini-scale, or Innovative handling systems to be able to work with APIs up to OEB Class IIIb but also IV on a case-by-case basis.