Your Environmental Monitoring Program is More Expensive Than You Think
Environmental Monitoring (EM) is a central element of Contamination Control Strategies (CCS) in pharmaceutical manufacturing, particularly in aseptic processing. It ensures the microbiological integrity within cleanrooms and controlled environments, which is essential for the production of safe and effective medicinal products.
Today more than ever, increasing regulatory expectations and the complexity of cost-constrained manufacturing make EM not just a compliance obligation but a strategic lever for quality assurance.
A well-designed EM program:
✅ Supports Good Manufacturing Practices (GMP) Annex 1
✅ Enhances process understanding and strengthens the state of control
✅ Enables early detection of microbial excursions
✅ Supports root cause investigations
✅ Protects patient safety
Cost control has become a strategic imperative, making it essential to conduct in-depth investigations into efficiency and productivity optimization to remain competitive and ensure economic sustainability in line with growing client expectations.
Leveraging bioMérieux’s extensive expertise in the pharmaceutical industry and environmental control, we answer your top questions to identify and understand the hidden costs associated with non-compliance in EM.
The insights presented here are based on extensive studies and interviews conducted with more than 50 QC managers and technicians, as well as QA and production representatives.
The Cost of Quality Explained – Our Expert’s Insights
Florian Morillon, Global Solution Manager at bioMérieux, shares his point of view on the cost of quality and how to reduce it without compromising on quality.
What does the “Cost of Quality” mean in Environmental Monitoring (EM) for Pharma Quality Control?
Environmental Monitoring costs are often overlooked in the true production cost of your pharmaceutical product. However, including EM costs in product costing is important to ensure more accurate financial planning as it highlights the true value of quality assurance. It also supports better decision-making for resource allocation and process optimization.
The cost of quality (CoQ) for EM refers to all expenses, time, and efforts incurred to ensure that environmental conditions meet regulatory and product safety standards.
CoQ is typically split into:
- The Cost of Good Quality which refers to the cost of quality conformity strategies to ensure specific standards are met (4 eyes reading, heavy documentation, inspection costs, training or qualification programs…)
- The Cost of Poor Quality refers to all the costs of non-conformites such as investigations, delays in product batch releases, conforming with FDA warning letters, scraps of product, re-tests…
What are the highest cost centers in environmental monitoring?
Environmental Monitoring in QC labs is a complex and resource-heavy process. You’re dealing with multiple variables—air, surfaces, personnel—and the process itself is highly dependent on accurate data capture, timely reporting, and stringent compliance.
This process is still highly manual, and many laboratories face significant challenges particularly with data traceability, accessibility, integrity, and consistency.
And these challenges can lead to sizeable costs.
bioMérieux’s in-depth study conducted with more than 50 QC managers, technicians, and QA investigators [see whitepaper below] indicates that the most costly elements are EM-based investigations management, reading EM plates, and documenting EM controls both during sampling and at QC labs.
Those 3 cost drivers can represent up to 400’000€ per year for a QC laboratory conducting 100,000 EM controls per year.
How much does a non-compliant sample cost?
Our study shows that a single out-of-spec sample triggering an investigation can cost €3,000+ on average. This does not include the potential product storage costs during an investigation and potential batch rejection.
The cumulative costs can easily exceed tens of thousands of euros depending on the product and stage of production.
What are the key levers to reduce EM costs without compromising on quality?
Two aspects can impact the cost of EM: organization and technology.
To ensure a sustainable and optimal outcome, one cannot be implemented without the other. In other words, implementing a new technology without changing organization mindset and processes will result in a faulty outcome—and vice versa.
Obviously, technologies that enable automation of EM data collection and reporting can drastically save time, particularly when it comes to EM activities documentation and EM plates reading—steps that usually involve many stakeholders from QC, QA, and manufacturing departments.
Is automated environmental monitoring worth the investment?
Absolutely. While initial investment is higher, automation can:
✅ Reduce manual labor
✅ Enable real-time alerts
✅ Reduce failure rates
✅ Reduce investigations and deviations
✅ Reduce training and onboarding time
✅ Support regulatory compliance
✅ Improve data accuracy, accessibility, and traceability
✅ Facilitate decision making
By analyzing environmental data trends in microbial counts, laboratories can identify early signs of contamination risks—enabling proactive interventions, such as adjusting cleaning schedules before thresholds are breached, and avoiding costly investigations and product loss.
Over time, it lowers both the costs of good and poor quality, offering a strong return on investment. The real profit is not only in reducing manual work or poor-quality costs, it’s also in unlocking the expertise of your staff to protect quality and speed up production.
Go further – Optimize your EM workflow & strengthen your audit readiness
Watch our focused technical webinar exploring the evolving landscape of Environmental Monitoring and quality practices within the pharmaceutical industry. Tailored for professionals in QC Microbiology, this session will delve into key topics including:
- Transitioning from dual to single temperature incubation in EM
- Strategic media selection for microbial recovery
- Preparing for audits: manual vs automated EM, system governance, and data integrity
- Leveraging electronic systems to enhance compliance and efficiency
- Evaluating the cost of quality and its broader impact across pharmaceutical operations
Featuring expert insights from Genevieve Greene and James Flynn, from NIBRT, and Florian Morillon, from bioMérieux.
Want information on our end-to-end solution for automated Environmental Monitoring?
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