Introduction

Steridelta W autoclaves are superheated water sterilization autoclaves specially designed for sterilizing large batches of parenteral solutions. The units have a high technical performance and GMP design in accordance with the applicable European standards: PED, CE marking, etc. They have a compact, modular structure allowing for quick installation and commissioning.

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 superheated water shower is used for sterilization, which is stored at the back of the chamber. Once the chamber has been loaded, the water is introduced at the back of the chamber and is propelled by a high flow sanitary pump towards the top of the chamber through a sanitary heat exchanger, which is used for both heating and cooling. In this way, the water is heated and accumulates at the top in a plenum system made from perforated stainless steel plates. The water falls like rain or a shower and completely wets the load, since the latter is also located on perforated trays. Excellent temperature uniformity can be rapidly obtained in the chamber by the high volume water flow.The load is cooled in the same way; when the sterilization temperature exposure time is reached, water cooling commences using the aforementioned heat exchanger. 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