Syrup and Suspension process plant is usually designed following exactly the same high-quality standards as for sterile process, in order to ensure compliance with GMP standards for customers too.

Manufacturers tend to produce syrup on their own, as this allows to have better control of final product. Syrup is produced by blending the API with water, sweeteners, flavour concentrates and minor excipients. 

On the other side, aqueous suspension preparations for injection are often a water-insoluble local anesthetic and/or narcotic analgesic in form of particles. In suspension, sedimentation and agglomeration of particles of active agents can occur, thus leading to clogging of injection needles or catheters.

The use of in-line homogenizer and mixer becomes essential during the process to ensure dissolution of the sugar in syrup preparation and to maintain the suspension stable.

The Syrup and Suspension plant is composed of 3 areas (Transfer station, Manufacturing and Filling areas) plus CIP unit, everything fully compliant with GMP standards. Manufacturing area is in turn divided into two areas. In process area there are three 5.000 L and one 6.000 L fixed vessels; four transfer pumping systems and four CIP return pumps. In the holding area there are four 5.000 L fixed tanks, two transfer pumping mixer and two CIP return pumps. At the beginning of the process, a vacuum sugar conveyor with rotating arm transfers dust bags to the emptying hopper and thus to process tanks through the valves group, together with liquid loading.

The Process basically consists in filling the tank with PW and other ingredients (i.e., kaolin, saccharin, sodium citrate, glycol etc.) while employing the in-line homogenizer and heating at predefined temperature for fixed time.