Evonik offers special hydrogen peroxide and peracetic acid grades for various applications in the pharmaceutical and medical industries. Such applications include dental or wound disinfection, decontamination of surgical instruments as well as treatment of contact lenses.
Solutions with higher hydrogen peroxide concentration are applied as chemisterilants in specially designed machines for decontamination of heat sensitive medical devices.
HYDROGEN PEROXIDE AS AN ACTIVE PHARMACEUTICAL INGREDIENT (API)
According to EU Directive 62/2011/EU on the community code relating to medicinal products for human use, it is mandatory for all producers of active substances used for medicinal products to be registered at the appropriate authorities of the country of origin to prevent the entry of falsified medicinal products into the legal supply chain.
Precondition for this registration is the approval of the production of the active ingredient according to GMP (Good Manufacturing Practice) guidelines. Evonik offers a special hydrogen peroxide grade PERSYNT® GMP manufactured under GMP conditions to meet the requirements of this regulation when using hydrogen peroxide as an Active
Pharmaceutical Ingredient and is also listed in EudraGMDP, a database for GMP certified manufacturers.
PERSYNT® GMP is suitable for the following applications:
Raw material for medical products & formulations
Wound cleaning & disinfection
Mouth wash & dental disinfection
Topical solutions (3wt%)
Hydrogen Peroxide and peracetic acid as sterilants and disinfectants
Depending on the manufacturer’s claims (biocide or medical
device), disinfectants used in the medical sector for decontamination may fall under two legislative acts of the European parliament.
Disinfectants of medical devices for the control of microbiological risks related to the environment are biocidal
products and regulated by Biocides Regulation 528/2012.
A disinfectant can be also considered as an accessory of a medical device and therefore has medical device status,
if it is specifically intended for the disinfection of medical devices that must be disinfected before use in accordance
with their instructions for use. In this case the European Medical Devices Directive (MDD) 93/42/EEC regarding medical devices is applicable.
According to Directive 93/42/EEC concerning medical devices, disinfectants are regarded as medical products and
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 to simplify the application process for a CE label. Evonik does not hold a CE label and is not selling a medical device, but our customers can go through a conformity assessment procedure by a certified body to be qualified as a manufacturer a medical device.
Hydrogen peroxide and peracetic acid as oxidizing agents
Every lot of our eical and pharmaceutical products is certified with a complete documentation. Our PERSYNT Pharma grades are tested according to compendial methods and are manufactured according to the standards of the
Due to our decades of experiences with hydrogen peroxide and peracetic acid our grades meet the specific
requirements of the pharmaceutical industry and are listed in the Monograph of the
EU-Pharmacopoeia/DAB (Deutsches Arzneimittelbuch).
For specific information regarding grades and formulations please contact your regional representative.Contact