Ciba Specialty Chemicals submits FDA master file for new antimicrobial test method NUMETRIKA
Ciba specialty chemicals together with its marketing partner BioGate has provided a comprehensive master file to the US food and Drug Administration (FDA), for its new antimicrobial test method called NUMETRIKA, a scientific methodology for the evaluation of antimicrobial performance of surfaces or devices. This master file can now be referenced by developers and marketers of antimicrobial-containing devices and products in order to support permissible efficacy claims and in obtaining regulatory approvals. The FDA master file complements the European accreditation granted in Germany (ZLG - Zentralstelle der Länder für Gesundheitsschutz) under EN ISO/IEC 17025.
The test method was developed by BioGate in the mid1990s and has been adopted by European clients. Global marketing of the method is now handled by Ciba's Expert Services Business Unit under the trade name NUMETRIKA. The highly sensitive procedure has been tested successfully in clinical applications and is patented in Germany. This automated method lends itself to the high throughput evaluation of antimicrobial performance in a fast and cost effective manner. This enables accelerated R&D compared with traditional antimicrobial test methods that are manual and rely on labor intensive cell counting. Due to the high throughput aspect, the described test method can also be used for quality control during the production of products with antimicrobial features.
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