Description

The unit's design offers the best performance for the terminal sterilization of parenteral solutions.

• High production capacity: A large variety of cylindrical chambers (without jacket) that enable high production loads and rectangular, horizontal sliding, cross-section doors, made out of AISI 316L stainless steel. The batch is loaded onto trolleys or pallets for loading to and unloading from the chamber.
• Ergonomics and flexibility: The loading and unloading logistics can be performed manually and fully automatically in the event of heavy and large loads. The automatic loading and unloading system consists of a rail system installed in front of the chamber mouth, where the trolleys or pallets are accumulated. The pallets, moving on skates, are introduced with a mechanical traction system located underneath the rails. As an alternative to this system, the autoclave can be installed inside a trench so that the loading is performed at floor level, using manual traction.
• Fully sanitary design: All the installation's necessary components and piping (valves, connections, filters, fans, heat exchangers, etc.) are accompanied by their quality certificates, in accordance with the standards corresponding to a sanitary installation. Criteria for ensuring the equipment's long useful life and easy maintenance are also taken into account in the design and installation. These components in particular should be of a high quality, mainly using AISI 316L stainless steel, Tri-Clamp sanitary seals, pneumatic actuation valves, etc.
• A mixture of pure vapour and air is used for sterilization. When the chamber has been loaded, steam is introduced and mixed with the air; therefore no vacuum pump is required. One or more fans (depending on the length of the autoclave), located at the top of the chamber circulate the air and steam mixture. The purpose of these elements is to achieve good temperature uniformity inside the chamber as soon as possible. The load is cooled, after the sterilization temperature exposure time, with heat exchangers located on both sides of the chamber. Given that the load cooling time undergoes a lag with respect to the temperature inside the chamber, compressed air is directly introduced into the chamber to counteract the pressure difference so that the product is not damaged.

• Easy to operate: The control system is designed to readily perform comprehensive recipe management and production reporting. It has a PLC and PC with a supervisory, control and data acquisition system (SCADA).

Accessories & Options

• Chambers customised in accordance with existing trolleys or pallets
• Automatic loading and unloading systems
• Additional temperature probes
• Graphical recorder according to requirements
• A range of customised loading accessories: trolleys, pallets, load carriers, etc.
• Product support trays or shelves.

Applications

Parenteral solution terminal sterilization has two critical aspects: the process effectiveness, that is, to obtain a cycle with a homogeneous temperature in the optimum time while preserving the physical integrity of the container at the end of the cycle.

In terms of effectiveness, the unit has been designed and constructed to enable the process to be rapidly validated and it has a reliable control system that provides a homogeneous and repeatable temperature distribution in the chamber.

With respect to the container's integrity, it is essential to select the sterilization unit that enables an adequate process to be carried out for each type of container. A poor choice can lead to plastic containers becoming misshaped, ampoules breaking and cracking and the plugs of vials or preloaded syringes being disturbed.

To ensure that these problems do no occur, the autoclaves for parenteral solution terminal sterilization must have a system to counteract pressure differences inside the container and the autoclave chamber during the heating and cooling phases.

Special Desings