Considerations For High Potent API Safety And Production

By Pere Hernández and David Fernández, Esteve Química

Working with High Potent Active Pharmaceutical ingredients (HPAPIs) requires thorough risk assessment, fit-for-purpose facility design, and significant investment in equipment and installations. Additionally, HPAPI handling implies meticulous operator training, wide procedure policy, and a strong safety culture.

While protecting operators is mandatory, HPAPI containment also serves to maintain product quality, prevent cross-contamination, and protect the environment. Containment strategies are designed to address various aspects of manufacturing, including material storage and transfer, sampling, waste management, and cleaning procedures.

Underestimating the complexity and challenges associated with HPAPI handling can lead to inadequate risk assessment, insufficient training, or inappropriate facility design. Accordingly, it is crucial to engage — as part of the project team — professionals such as process safety engineers, industrial hygienists, and containment experts who can provide guidance and support in understanding the requirements and implementing robust HPAPI-handling practices.

Regardless of a client’s experience with or concerns surrounding HPAPIs, Edsteve is enthusiastic to help them along the most efficient, effective path to achieving production at any scale. Our organization is ideally sized in having the resources to serve a variety of client needs while not being bogged down by the kind of high-level bureaucracy that slows decision-making. From lab scale to commercial production reactors, we can manage OEL 30 ng/m3 highly potent ingredients.