Sterilisation of medical devices with a touch of excellence

Sterilization of medical devices is taking place at thousands of sites around the world since decades.

Handling of the dangerously emissions, however, is carried out very differently. Legislation is in place, however with regional differences.

Authority control is increasing since there are issues and incidents – from time to time.

Understanding EtO emissions from sterilization process is underlined by the challenges associated with finding appropriate pollution control for all different sources of emission.

The general experience may differ from site to site, here are 2 common ones:

  • Fugitive emission, especially from aeration and back vents, are not always properly routed to abatement.
  • Keeping emissions constantly low requires not only a lot of management attention, but also the willingness to pay the costs of having 2 or more technologies working to clean the different air flows.

Poorly designed or mismanaged pollution control systems have led to plant closures in US and China.

LESNI's innovative and proven solution purifies all the emissions from the sterilization of medical devices. This delivers a safe and reliable "state of the art" system that meets the current stringent regulation with high destruction efficiency.

The recognized LESNI balancer/abator system provides a very controlled approach to handling competently hazardeous ethylene oxide gas. This secures lowest discharge emissions (currently as low as 0.5 mg/Nm³ according to TA-Luft). LESNI also design and supply quality integrated Preconditioning and Degassing / Postconditioning Cells for this industry. Energy costs are substantially reduced by the incorporation of well sized recuperative heat recovery. The Catalytic Abatement Plant "EO CAP" is designed to treat all potential low fugitive air extracts from degassing and aeration, as well as the vacuum pump high concentrate vents and the waste liquid seal.

LESNI have installed 100+ of the well proven solution (balancer/catalytic abatement, type EO CAP) as air pollution control device (APCD) units at EtO sterilizing plants globally. The first plants in Europe from the 1990s showed cleaning effects of higher than 99,9%  (resulting in emissions below 0.5 mg/Nm3)– and as this became achievable – the European Authorities set this as Best Available Technique (BAT) – and hence the German TA-Luft has set this as emission limit.

In the USA, currently more than 15 global medical device manufacturers and contract sterilization sites are now confidently operating the LESNI EO CAP system and meeting local emission requirements with ease:  

  • All emissions connected to abatement!
  • 0,5 mg/Nm³ EtO emissions at any time!

ETO emissions – a solvable problem, since decades.