Description

The design of the equipment offers the best performance for the terminal sterilization of thermo-sensitive medical-health products.

• High production capacity: Rectangular cross-section chamber made entirely from AISI 304L stainless steel with a jacket made in U-shaped sections from the same material which completely surround the chamber. In contract to other designs, the empty chamber provides temperature uniformity within ±3 ºC.

• Customised configuration: Automatic sliding horizontal or vertical doors with automatic closing and sealing that does not require inflatable gaskets. Technical component installation on separate skids depending on ATEX requirements.
• Fully ATEX compliant design, construction and functions, endorsed by Ineris through hazard and operability (HAZOP) and safety tests. Instrumentation with ATEX certification. Simple to install pipes and auxiliary equipment (pumps, fans, etc,). Consistent material selection (preferably stainless steel).

• Operational safety: Flexible SCADA system that enables operation and optimization of cycles with complete safety. The control system cannot be bypassed or manipulated under any circumstances which would lead to the risk of explosion.

Accessories & Options

• Automatic loading and unloading systems
• Automatic bottle change
• Gas room and weighing scales
• Equipment integration for parametric release
• Integration with gas treatment (EtO) systems
• Conditioning and airing rooms
• Clean steam generators

Applications

Given the risks involved with ethylene oxide as a carcinogenic agent, GMP specifies that this type of sterilization should only be used when there is no safer alternative. Nevertheless, in the medical device manufacturing industry, EtO is still the most efficient sterilization agent. Medical devices are products which are thermo-sensitive and delicate; whether this is due to the type of material, the nature of their design or the type of instrumentation. In this case, investment in sterilization equipment using EtO is fully justified.

Special Desings