High potency APIs
Providing our customers with additional HPAPI manufacturing capabilities.
In 2015 Esteve Química decided to increase its current manufacturing capabilities with potent compounds. To this end, the decision was made to install the following units:
- A laboratory for high-potency APIs located at our R&D center in Barcelona. This laboratory is equipped to work with OEL above 1 μg/m³ and performs process development (under cGMPs if needed) with the possibility of manufacturing under future cGMPs very low commercial HPAPIs (annual quantities below 500g).
- A manufacturing unit allowing HPAPIs to be manufactured under cGMPs with OEL above 1 μg/m³. The batch size for this unit is between 3-15 kg. Reactors are equipped with isolators for loading and sampling with containment, and the facility is also equipped with several isolators for the filtration and drying of the products in an enclosed Hastelloy filter dryer, one of them equipped with a multi headed mill for milling and sieving and one isolator for sampling, dispensing and packaging.
- A Quality Control laboratory for high-potency APIs. This Laboratory is equipped with safety cabinets for the handling, samples preparation and the most usual technics and equipment for the analysis of HPAPIs.