For a Sterile Environment
Hydrogen peroxide and peracetic acid are suitable for the removal of contamination by microorganisms from medical equipment and the cleaning of surfaces in medical and pharmaceutical rooms, as well as pharmaceutical isolators.
Compliance Standards for Hydrogen Peroxide and Peracetic Acid in Medical Device Disinfection
The use of disinfectants and sterilants is strongly regulated in all regions of the world. The statements below mostly refer to the current European regulations. For other parts of the world, please ask our experts for specific advice.
Depending on the manufacturer’s claims (biocide or medical device), disinfectants such as hydrogen peroxide and peracetic acid used in the medical sector for decontamination may fall under two legislative acts of the European parliament:
- Disinfectants for the control of microbiological risks related to the environment (rooms, general surfaces) are biocidal products and regulated by Biocides Regulation 528/2012.
- According to the European Medical Devices Directive (MDD) 93/42/EEC, disinfectants of medical devices must be produced according to EN ISO 13485. Evonik offers special hydrogen peroxide grades under the brand name PERSYNT Steri and the special peracetic acid grade PERACLEAN Steri, both produced compliant with EN ISO 13485, specifically for this use. These products allow Evonik’s customers, medical device manufacturers, to simplify the application process for a CE label. Evonik does not hold a CE label and is not selling a medical device.
Sustainable Decontamination with Peracetic Acid and H₂O₂
Considering the requirements of a sterile environment in the medical and pharmaceutical sector, the question arises whether disinfection without chemicals is possible. Our answer to this is the use of our peracetic acid and high-purity hydrogen peroxide products, completely natural substances that can be used alone or in combination with other substances such as ozone in concentrations of up to 98%, depending on the application. For cleanrooms in medical technology, life sciences, medical research, and treatment, we offer high-purity vaporized hydrogen peroxide against airborne and microbiological contaminants, which can be used directly and without any additional modifications for biodecontamination.