Molecular Solutions for Pharmaceuticals
Our Lab uses molecular technology to provide pharmaceutical testing services in rapid turnaround 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 the investigation of possible microbial contamination, QA and QC processes would benefit most from accurate Microorganism Identification, sourced from products, materials or the environment. Microorganism Identification at species level is mandatory for microorganisms detected in grade A zone and grade B area according to Annex 1 V12.
QACS Lab performs accredited Microorganism Identification at species level using DNA technology. Recognized as the most reliable for the classification of microorganisms, DNA identification presents a reliability advantage over other methods e.g. APIs that are metabolic, MALDI 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 Lab assist you to resolve the causes of microbial contamination, through investigation of the microbiological origin and analysis of the deeper causes upon request.
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 testing.
We perform rapid and accurate pathogen detection via Real Time PCR to ensure product safety. Pathogenic bacteria of the genus Salmonella, Listeria, Shigella and others after enrichment are detected in 24h.
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.
Environmental Monitoring in Pharma Production
The Power of Metagenomics
Τhe MMS approach from QACS, combines the long standing microbiology experience of our experts on plant and production areas. With the power of NGS and metagenomic analysis you can accurately :
- Map and monitor the complete microbiome of your production facility.
- Pinpoint pathogens and contaminants in the environment.
- Identify their routes and biofilms.
- Track their sources proactively.
- Gain full insight of the microbial populations in your production environment before it affects your products.
- Use the data retrospectively to identify possible sources of contamination in case of QC failure.
Untargeted approach: You only find what you look for…
Although bacteria can be found anywhere, their presence in production environments, such as cosmetics/drug manufacturing and food processing plants, poses a constant threat.
When harmful or spoilage bacteria enter a product, QA/QC managers face a huge challenge to control/prevent recalls. Since production processes nowadays are well designed and automated, to control unwanted bacteria, you mostly need to control the environment of your production.
The classical approach with swabs and culture plates only detects a limited number of microorganisms that are able to grow in the conditions used, and with a variable performance. Their results are often difficult to interpret or even meaningless.
MMS gives an untargeted approach to this procedure revealing the full picture:
- Samples are taken from all important sources in the production environment.
- Total DNA is isolated from all samples and sequenced with NGS.
- The full depth of the microbiome of each sample is revealed from each sample analysis.
- Combining the results of each sample a full microbiome map of the production environment is revealed.
- Metadata analysis, heatmaps and most of all our expert’s insight results in a comprehensive report with clear interpretation of the finding and suggestions for corrective actions.