• Biocompatibility tests according to the ISO 10993 or to USP;
• In vitro and in vivo Toxicology tests;
• Validation of Sterilization Process (ISO 11134-11135-11137);
• Validation of Cleaning and Clean Areas processes (ISO 14644 ISO 14698);
• Validation of Packaging Materials and Systems for Medical Devices which are to be sterilized (EN 868, ISO 11607)
• Nebulizers Tests for EN 13544 and FDA compliance: Particle sizing, VOCS, PM10 PM2.5
• Disinfectant efficacy tests  in compliance with the latest European Community provisions;
• Validation of virus removal or inactivation processes (EN 12442-3);
• Chemical, microbiological and biological testing of medical devices;
• Sterilants and chemical residues, chemical extractables;
• Microbiological tests of foodstuffs;
• Analysis and services for cosmetics and pharmaceutics industry; chemical analysis for food industry and environmental and echological analysis

Biochem's Quality System is accurately maintained in compliance with UNI CEI EN ISO 17025:2005 requirements  and is ACCREDIA SINAL n°283 certified. The complete schedule of accreditation is available from the ACCREDIA SINAL web site http://www.sinal.it/ita/asp/Ricerca.asp

Biochem has been authorized by D.M. of the Italian Health Minister N° 800.5/OFF. 1022/5051 to perform biological, microbiological and chemical examinations of medical devices.

The objective of Biochem's services is to meet the clients exact requirements and avoid recommending unnecessary and costly services if not absolutely necessary.

The success of Biochem's "client service" is based on providing a wide range of services, into all of which are incorporated the common attributes of independence, competence, proven experience, rapid and prompt service and constant attention to the customer's requirements.

For professional advice of the highest quality related to the above fields of interest or to enquire further about the range of special services that Biochem offers, please contact: