Environmental Monitoring services
Environmental monitoring is essential in pharmaceutical manufacturing to ensure cleanroom and facility conditions meet strict regulatory standards. Controlling microbial and particulate contamination safeguards product quality, patient safety, and compliance with GMP requirements. At QACS, we provide comprehensive Environmental Monitoring for Pharmaceuticals to help pharma companies maintain controlled environments and demonstrate continuous process control.
To ensure the absence of previously manufactured pharmaceutical materials & impurities from production equipment, the GMP certified QACS Lab performs Environmental Monitoring for Pharmaceuticals using suitable analytical techniques. The laboratory’s quality assurance approach begins with the preparation of a protocol and ends to the qualification of analytical results.
Cleaning Validation studies ensure that a routine cleaning process performed on manufacturing equipment removes all residues of previously manufactured products.
At QACS perform cleaning validation testing by developing and implementing validation protocols, to document method suitability.
At QACS we validate linearity, intermediate precision, recovery and specificity. Cleaning validation for manufacturing equipment includes testing of preparations, storage tanks, filling nozzles, tools & instruments.
MMS is a system-level approach to understanding and controlling the microbiology of production environments.
In modern manufacturing, contamination events are rarely caused by a single point failure. They emerge from complex interactions between raw materials, water, air, equipment, surfaces, people, and processes. Traditional environmental monitoring methods capture isolated snapshots of this system — often too late and with limited context. Metagenomic Mapping Service (MMS) changes this perspective. By combining high-resolution metagenomic sequencing with structured sampling design and deep industrial interpretation, MMS reveals how microorganisms persist, move, and interact across the entire production environment.
From detection to understanding
Sequencing alone does not solve microbiological problems. Value lies in translation.
MMS converts complex DNA data into clear, actionable insight, allowing manufacturers to understand:
- where microbial reservoirs are established,
- how contamination routes form and propagate,
- which zones contribute risk to others,
- and where preventive intervention is most effective.
What Metagenomic Mapping Service delivers:
- A comprehensive microbiome map of the production environment
- Early identification of hidden contamination risks and biofilm behaviour
- Understanding of microbial transfer pathways between zones and processes
- Risk-based prioritisation of hygiene and corrective actions
- Support for root-cause investigations following QC deviations or incidents
- A proactive framework for preventive environmental risk assessment
Built on real industrial experience
MMS has been implemented in more than 100 industrial projects across food, pharmaceutical, and cosmetic manufacturing environments. Through this work, QACS has developed practical expertise on where to sample, how to interpret patterns, and which corrective actions deliver sustainable control.
This experience is what differentiates MMS from generic metagenomic or NGS services.
A preventive control tool
MMS is applied both:
- reactively, during contamination incidents or recurring failures, and
- proactively, as a periodic environmental microbiological risk assessment.
Many manufacturers now repeat MMS assessments to verify the effectiveness of hygiene strategies, process changes, or facility upgrades — before problems reach products or consumers.
MMS is not just about seeing what is present.
It is about understanding what matters — before it becomes visible.
In compliance with the current GMP Annex 1, QACS laboratory offers Environmental Monitoring services for GMP manufacturing areas. We specialize in the preparation and implementation of the manufacturing area through Environmental Monitoring programs involving air and surface sampling.
We undertake protocol compilation, sampling, testing and reporting using Molecular biology tools-DNA Microlab, QACS Labs provide the advantage of rapid, accurate microorganism identification.
Environmental Monitoring
For Cleaning Validation & Monitoring solutions contact us – [email protected] – +30 210 29 34745