Cream, gel and suppository plants have to daily handle high-viscosity products. The engineering has to therefore take into account the physical characteristics of the product and the interaction of the various ingredients, in order to design a plant which will produce a smooth and stable drug or cosmetic. To this extent, top mounted agitator and high-speed homogenizer are usually applied. Temperature Control Module is fundamental too, because it allows to melt excipients – where the API is added, to keep the temperature stable and to have a full control of temperature settings.

Ideally the plant has to be equipped with a CIP station, where acid and base additions can assure the cleanliness of vessels and distribution piping.

The Suppository Plant has been designed to be a “plug-n-play” model: full pre-assembled and cabled in the workshop, immediately operative once at customer’s site.

It’s composed of one 750 L homogenizer fixed tank jacketed; heated loop to filling line; stainless-steel skid; one temperature control unit; a rotor/stator homogenizer with AISI 316L impeller, max. product viscosity 100 cP, max. speed 2.800 rpm; one anchor mixer for max. product viscosity 100 cP, polish: Ra<0,5 µm; load cell weighing system; one CIP SKID (stand-alone unit).

Automation system is compliant with GAMP 5 and FDA 21 CFR Part. 11 and is based on modular PLC interfaced with I/O devices. The plant is equipped with multiple HMI and managed by a full SCADA for recipe, batch management, data storage and reporting.