Product Catalogue

General Information about biological indicators

Sterilization procedures in hospitals have reached a high standard of quality. Necessary monitoring procedures are costly, however important, to ensure long-term asepsis in all fields of surgical operations.

International and local standards and directives like the European Medical Device Directive (MDD) require validation, batch monitoring and documentation of sterilization processes.Besides industry, healthcare facilities must follow the same validation, monitoring and documentation procedures. Validation and monitoring of sterilization processes is carried out by parametric, chemical and/or biological tests. The validation using biological indicators is necessary if:

• ? The structure of the goods to be sterilized is such that physical sensors cannot be applied (e.g.: small holes, gaps, sealed areas, coatings with oils etc.)

• ? lumens of hollow devices are so tiny that the temperature difference between non-condensable gases (inside) and steam (outside) is not detectable. Gases in such small lumens of several 100