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.

Using Metagenomics we study the genetic material of microorganisms in a given environment to provide valuable insights for quality control and safety in all industries.

Primary goal of Environmental Monitoring and MMS is to help brands maintain high-quality standards in their pharmaceutical production processes by closely monitoring & understanding the microbial populations within their facilities. We combine long-standing microbiology experience of plant areas with the power of NGS and Metagenomic Mapping to 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 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 are looking for! The presence of bacteria in production environments poses a constant threat to QA/QC managers who might face a huge challenge concerning recalls. The classical approach with swabs and culture plates only detects a limited number of microorganisms and often results are difficult or even meaningless to interpret.

Microbial Mapping from QACS Lab 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.