The regulations USP (United States Pharmacopoeia), EP (European Pharmacopoeia) and DAB (Deutsches Arzneibuch), recommend the use of bioindicators during the sterilization processes of drugs, medicines in vials, culture media, medical instruments and others.
Bioindicators are used for the validation, qualification and monitoring sterilization processes.
Liofilchem® provides a wide range of biological indicators for the steam, ethylene oxide, dry heat, hydrogen peroxide and irradiation sterilization processes.
Biological Indicators manufactured by Liofilchem® are available in ampoule, self-contained, strip, suspension and coupon formats in several materials such as glass, aluminum, poliflex, steel, PVC; Liofilchem® also produces custom-sized Biological Indicators on request.
All Biological Indicators have a certificate reporting D and Z values, survival time, kill time, population and purity.
Biological Indicators are manufactured in strictly controlled environment in order to fulfill the requisites indicated in USP and EP and in accordance with ISO 11138 and EN 866 regulations.