from Molecule to Market with Innovation

from Molecule to Market with Innovation

Parenteral Formulation Compounding

A dedicated multi-disciplinary team to develop a challenging project: a huge emulsion plant. A project started from green field, a process plant whose peculiarities lie in its majesty, in the ability of managing the engineering, the electronics and the automation, while guaranteeing a high level of flexibility in the transfer systems.

Fully customized, compliant with cGMP and GEP specifications and requirements. A sophisticated automation system connected to the beating core of the plant: a block valve skid, that manages the whole transfer system of the plant.

Two CIP Skids that operates in different areas of the plant at the same time to reduce down time.

Virtual Commissioning has been managed before plant construction to analyze process phases, identify and solve bug before the real start-up step.

The Emulsion Plant is composed of three process rooms, two compounding rooms and one holding room.

In the formulation rooms the main part of the process takes place: the oil solution in the 500L tank and the water solution in the 2800L tank are mixed and, through sterile filtration lines, sent to the third 3000L tank. The solution obtained is then passed through a high shear mixer, later through a high-pressure homogenizer. The mixture obtained, is stored in the holding room (four 3000L tanks), ready for the filling lines.

Piping from compounding and holding rooms is connected to the Block Valve Skid; the Mix Proof Valve Skid manages cleaning and sterilization instead.