Molecular Solutions for Pharmaceuticals
In order to find a possible source of microbial contamination, QA and QC would benefit the most from accurate microorganism identification sourced from products or the environment. QACS identifies microorganism at species level. The species name is indicative for the origin of a microorganism, its habits, possible pathogenicity and its vulnerabilities. The identification of microorganisms at the species level is mandatory for microorganisms detected in grade A zone and grade B area according to Annex 1 V12.
At DNA Microlab, it’s possible to identify species of microorganisms using DNA technology. The DNA identification method is globally recognized as the most reliable for the classification of microorganisms. DNA identification techniques present a reliability advantage over other methods e.g. APIs that are metabolic. MALTI TOF or other immunochemical methods.
In addition to the micro-organism species name, information on the ecology, classification, growth conditions and possible pathogenesis are provided. QACS scientific instructions and solutions resolve the causes of microbial contamination, through investigation of the microbiological origin and analysis of the deeper causes upon request.
Environmental monitoring services facilitate compliance with GMP Annex 1 V12. Services specialize in qualification studies (PQ) of new production sites as well as in the preparation of environmental control programs involving air and surface sampling.
We undertake to work with you on the protocol preparation, to implement the protocol through sampling and testing and to prepare the reports. DNA Microlab molecular tools identify any microorganism, that may occur, at species level and properly document the premises flora as provided by Annex1. Environmental monitoring services are available for a variety of classified production areas, and especially for new or refurbished facilities.
Worldwide pathogenic bacteria are of growing public health concern. We perform fast (24h) and accurate pathogen detection via Real Time PCR to ensure the product’s safety.
Pathogenic bacteria of the genus Salmonella, Listeria, Shigella and others after enrichment are detected in 24h via Real Time PCR.
For Pharmaceutical testing services, contact us here, email firstname.lastname@example.org or give a call at + (30) 210 29 34745