Molecular Solutions for Pharmaceuticals
Our Lab uses molecular technology to provide pharmaceutical testing services in rapid turn around times. DNA Microlab, member of QACS assists pharmaceutical manufacturing and monitoring processes in order to secure the absence of microbial contamination via Microbial Species Identification, Pathogen detection & Environmental monitoring testing services.
In order to find a possible source of microbial contamination, Quality Assurance and Quality Control processes would benefit the most from accurate microorganism identification sourced from products or the environment. QACS identifies microorganism at species level.
QA and QC processes would benefit most from accurate microorganism identification in the investigation of possible microbial contamination in materials, utilities and the manufacturing environment.
The species name is indicative of 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.
DNA Microlab, member of QACS, identifies 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 are in 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 work with you
- on the protocol preparation
- on the protocol implementation on sampling
- on testing
- on reporting
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 a growing public health concern and pose a great risk to industry reputation. Protect your brand from costly product recalls by proceeding to Pathogen Detection.
We perform fast (24h) sensitive 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.