Decontamination and pharmaceutical synthesis
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.
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 EU-Pharmacopoeia.
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 hydrogen peroxide and peracetic acid grades and formulations please contact your regional representative.
HAND and surface DISINFECTION
PERSYNT® 3 LC is used in WHO alcohol-based hand-rub formulations.
Evonik has recently extended its portfolio with the product PERSYTN® 3 LC, an aqueous solution of highly purified hydrogen peroxide, which is dedicated for the preparation of a WHO-recommended alcohol-based hand-rub formulation.
Hydrogen peroxide is used to inactivate bacterial spores in the disinfecting solutions and is not an active substance for hand disinfection. The corresponding recipes are defined by the WHO.
PERSYNT® 3 LC has a 3% concentration of H2O2. Additionally, Evonik offers PERSYNT® 300 LC with a higher concentration of 30% H2O2.
PERACLEAN® 5 is a disinfectant with a broad application spectrum, which is used in particular in the food and beverage industry. In the food industry, disinfectants containing peracetic acid, are part of the disinfection of installations, tanks, pipelines and equipment as well as for packaging material.
PERACLEAN® 15 has demonstrated effectiveness against viruses similar to SARS-COV-2 on hard non-porous surfaces. Therefore, it can be used against SARS-COV-2 when applied in accordance with the directions for use against Human Corona virus strain 229e. The peracetic acid product is a solution to help preventing the spread of germs on common surfaces that people may come in contact with, such as door knobs and hand rails.
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 and formulations
- Wound cleaning and disinfection
- Mouth wash and dental disinfection
- Foot disinfection
- Topical solutions (3wt%)
- Medical therapy