HA2 Medizintechnik GmbH has erected one of Europe’s most modern gas sterilization plants in the heart of Germany.
Since 1998 we have provided professional sterilization services for single-use medical devices using ethylene oxide. On a hall surface covering more than 4000 m², the products to be sterilized are
● sterilized and
in defined chambers.
All processes meet the requirements of DIN EN ISO 11135-1 .
Prehumidification and sterilization process
The products are prehumidified in the sterilizer. Owing to their enlarged surface, gas penetration is improved and, thus, a better germ-killing effect is achieved. After humidification, the gas is introduced and acts over a certain period of time. The exposure period is followed by aeration and a desorption phase allowing to accelerate off-gassing of the products.
Biological indicator and ethylene oxide residual verification
The successful sterilization is monitored at our microbial testing laboratory using biological indicators. The gas-chromatographic system allows to regularly and quickly monitor the environment of the sterilization plant and to determine the presence of any residual gas in the sterilized medical devices. The laboratory also allows to carry out germ count determinations for the purpose of microbial control of the clean rooms in our company and other enterprises.
Last Updated ( Dienstag, 19 April 2011 )