High Potency Active Pharmaceutical Ingredients (HPAPIs) are generally defined as API that have an occupational exposure limit (OEL) of less than 10 μg/m3. They require the minimization of risks associated with occupational exposure and contamination. In addition, there is a growing demand for the consideration of raw materials with an OEL of 100 μg/m3 (OEB Level 3) or less as HPAPIs and for the requirement to work in safer facilities.
The handling of HPAPIs requires specialized infrastructure for safety, containment, and analysis, as well as highly trained personnel.
Our company has facilities for the safe handling of HPAPIs, and we have developed processes at laboratory, pilot, and commercial scales (from 10 g to 50 kg) for a variety of HPAPIs above OEB Level 3
Our highly trained personnel are also capable of handling HPAPIs in compliance with GMP
| BAND | OEB1 | OEB2 | OEB3 | OEB4 | OEB5 |
|---|---|---|---|---|---|
| OEL | ＞1000 -5000 ㎍/㎥ |
＞100- ≤1000 ㎍/㎥ |
＞10- ≤100 ㎍/㎥ |
＞1- ≤10 ㎍/㎥ |
＞1.0- ≤0.001 ㎍/㎥ |
