When selecting an autoclave for terminal sterilization of liquids, these two questions have to be taken into account: 1) Selecting the chamber dimensions according to the critical batch quantity. The load has to be placed into the chamber properly so that homogeneous temperature distribution / penetration throughout the whole load has to be attained in a way that it can be reproduced (i.e. the process can be validated). 2) Investigating the process method and cycle recipe so the physical condition of the container at the end of the cycle remains unaffected. The wrong choice may lead to deformation of plastic containers, breaking or cracking of flasks and movement of stoppers in the case of vials and pre-filled syringes. Our SteriDelta autoclaves are specially designed for terminal sterilization of liquids in closed containers as they are prepared to provide automatic differential pressure compensation based on product probes temperature measurements (ΔT) so deformation and damage of the plastic containers is prevented.
Steridelta W autoclaves are superheated water sterilization autoclaves especially designed for sterilizing large batches of parenteral solutions. The units have high technical performance and GMP design in accordance with the applicable European standards: PED, CE marking, etc. They have a compact and modular structure allowing for quick installation and commissioning. These units are fitted with a high-flow recirculation system, using a sanitary pump and heat exchanger. This allows the use of process water as heat transfer media, for the heating up, sterilizing and cooling down of the load. This process method provides faster cycles but containers come out moist. However, it is the preferred method in most cases due to its simplicity, economy and ease of validation.
