INOXPA finished a turnkey project (in Spain) of a pharmaceutical plant covering production, storage and filling line for pharmaceutical syrups, suspensions and preparations for drinkable ampoules.
INOXPA carried out the entire project starting from the initial basic design and finishing with putting the plant into operation and its validation.
Description of the plant
Preparation. Four 3000L preparation reactors were installed and provided with a load cell weighing system to control the addition of the ingredients for 14 different preparations. The reactors are designed to resist vacuum and are provided with heating/cooling jackets; every reactor is equipped with 8 diaphragm valves, one of them is a bottom valve.
The addition of the solid and some liquid ingredients is made in vacuum through the lower part of the preparation reactors. The addition of the ingredients is performed from the two attached clean rooms, from these rooms, the ingredients can be added to all four preparation reactors.
Syrups and suspensions are homogenised and dispersed by means of bottom saw-tooth propellers, magnetic agitators and mixers. The anchor type agitators installed in the reactors for preparation of viscous products are provided with nitrogen barrier mechanical seals.
There are two reactors designed for other preparations, a manifold with twelve diaphragm valves and two inline mixers were installed for this purpose; this equipment permits the selection of a tank, recirculation in the same tank and selection of a reactor while the preparation is homogenised.
Transfer and filtering. The final product is transferred from the reactors to the storage tanks by means of a distribution manifold supplied with forty diaphragm valves that permit the transfer of the product from the four reactors to five storage tanks through two transfer lines.
Two BioClean 3-50 lobe rotor pumps are used as transfer pumps.
Between the preparation reactors and the storage tanks, there is a filtration system - a flow divert panel with bends - that provides three filtering options.
Storage and bottling line. The final product is stored in three tanks, one for 3000L and two for 6000L, provided with tank bottom magnetic agitators. Two tanks for highly viscous products are supplied with anchor type agitators with nitrogen barrier seals.
These five storage tanks can simultaneously feed two filling machines, one for syrups and the other for drinkable ampoules, by means of 35 valves that connect the tanks with the filling lines, not all the tanks are connected to the filling lines but the design of the manifold permits its possible ampliation. The pumps used are the same transfer pumps used to transfer the product to the storage tanks, BioClean 3-50 lobe rotor pumps.
Sanitation and cleaning. A CIP unit was installed to perform cleaning and sanitation of the plant: cleaning cycles with two different cleaning agents, rinsing and sanitation at 85 ºC. The cleaning process conforms to the pharmaceuticals methods, thus, no substances are recovered to avoid cross contamination. The cleaning unit consists of a purified water storage tank for 100L connected to the transfer pump, dosing pumps, instrumentation and the heating system.
The KH single seat valves of the manifold are connected to the flow divert panel for selection of the line or tank for cleaning.
Plant. The components in contact with the product as well as reactors and storage tanks were designed in compliance with the BPE and GMPs regulations. The material used is AISI 316L with Ra ≤ 0,5 µm surface finish and orbital welding was applied to weld pipes.
For the assembly of the plant, about 400 m of the BPE pipe and some 600 BPE fittings (bends, liners, etc.) were used. The plant was constructed on 200 m² space.
Control system. The control system controls the entire plant and consists of the central Siemens 300 PLC with WinCC acquisition. In every clean room and bottling room, there are panels to control the processes performed there. The Profibus network communicates the PLC with the SCADA as well as all the load cells (nine load cells) and five control boxes with input/output modules to record the signals of the field instrumentation.