PPQF


The Fine Chemicals Pilot Plant Unit is tasked with designing, synthesizing, optimizing, and scaling any organic molecule entity according to the user's needs, encompassing the requirements specified in the "ICH Guidelines." This includes elucidation, synthesis, and characterization of synthesis impurities, degradation products, nitrosamines, and drug metabolites, generating standards.
The Fine Chemicals Pilot Plant is primarily located in the northern part of the building. It consists of twelve fully equipped laboratories for chemical synthesis and eight ATEX industrial rooms with an area of 475 m². These facilities ensure the effective development of projects up to the pre-industrial stage, with efficient technology transfer from the CQAB to the company.
The laboratories are designed to house fume hoods suitable for the synthesis, optimization, and scaling of processes in reactors up to twenty liters in capacity, with working temperatures ranging from -90 to 170 ºC, which form the so-called Kilolab.
The industrial rooms are designed to accommodate reactors from 50 to 400 liters with working temperatures between +0 and +170 ºC.
The research laboratories and industrial rooms are entirely independent of each other, and the activities conducted within them are carried out under strict confidentiality measures and rigorous quality and safety standards, both for the researchers working there and for the products under investigation and/or development.
Adjacent to the area housing the Fine Chemicals Pilot Plant, there is a "bunker" type facility located at the rear of the building (west facade) designed to support processes requiring special safety measures. This is either because they involve the use of gases that require special precautions (hydrogen, ammonia, carbon monoxide, hydrogen chloride, etc.) or because they need to be conducted under high pressures (10-25 atmospheres). This facility, covering about 30 m², includes all necessary safety measures for this type of work and is duly authorized by the D.G. of Industry.