Cleantrol EM™ — Environmental Monitoring Software
Risk-based viable and non-viable monitoring for cleanrooms and other controlled environments.
What Cleantrol EM Is Built For
Cleantrol EM is environmental monitoring software for cleanrooms and other controlled environments. It manages sampling for viable air, viable particulates, and surface viables, and is built around risk rather than a fixed checklist — sampling frequency and location weight are set by where contamination risk actually concentrates, not by treating every grade and location the same.
It supports assessment of cleaning and disinfection effectiveness, identifies trends before they become excursions, and manages EM scheduling through a daily interactive calendar and workload manager. Deviations arising from monitoring results are handled as part of the same workflow, instead of sitting in a separate system that someone has to remember to check.
"The FDA believes manual systems of environmental monitoring (EM) have large inherent operational risks... Computer trending for pattern recognition is the most efficient and effective way to handle such large quantities of data."
Key Core Features
Comprehensive tools for total environmental control.
Risk Based Assessment
A surveillance system that provides a baseline profile of a manufacturing environment. Acts as an early warning system to detect possible environmental contaminants out of limits.
Interactive Schedule
Monthly interactive calendar arranges day-to-day monitoring tasks. Access monitoring details directly to track viable counts and organize activities perfectly.
Instant Trending
Critical tool for evaluating facility performance. Manage circumstances when the facility deviates from normal parameters by understanding large volumes of data.
Instant Reporting
Secure web portal provides 24/7 access to sample status. Download Excel, Word, PDF reports. Samples exceeding limits are automatically highlighted.
Data Visualization
A dashboard toolbox for visualizing trends in large-scale environmental data. Tracks, analyzes, and displays KPIs and critical data points to support informed decision-making.
Why Contamination Control Gets Audited Hard
Maintaining a controlled environment matters across pharmaceutical manufacturing, food processing, and biochemical labs because contamination that gets past environmental monitoring can compromise product quality before anyone notices — and by the time a finished-product test catches it, the batch is often already made.
Cleantrol EM keeps three things in one place: the sampling schedule, the counts against alert and action limits, and the cleaning and disinfection effectiveness data that explains why a count moved.
- ✓ Baseline: A documented profile of normal counts by location, so a shift stands out.
- ✓ Compliance: Alert/action limit tracking aligned to EU GMP Annex 1 and internal specifications.
- ✓ Traceability: Every exceedance linked to its investigation and corrective action.
The Regulatory Requirement: EU GMP Annex 1
Environmental monitoring stopped being a background checklist item when Annex 1 was revised in 2022.
The 2022 revision of EU GMP Annex 1 asks manufacturers of sterile products to hold a documented Contamination Control Strategy (CCS): a live, evidence-based view of where contamination risk sits in a facility and how it is monitored, not a static procedure filed away and reviewed once a year. Environmental monitoring data is central to that evidence. A CCS built on isolated pass/fail slips does not hold up the same way one built on trended, location-specific data does.
Cleantrol EM's own product literature echoes an FDA position on this directly: "The FDA believes manual systems of environmental monitoring (EM) have large inherent operational risks… Computer trending for pattern recognition is the most efficient and effective way to handle such large quantities of data." A risk-based sampling plan, alert and action limits set per location, and a trend view that updates as results come in are what turn raw counts into the kind of evidence a CCS review actually needs.
How an EM Sample Moves Through Cleantrol
The same path runs whether the sample is viable air, a settle plate, or a surface swab.
- Scheduling — the interactive calendar assigns sampling locations and frequency by risk grade, so a Grade A/B area is not sampled on the same cadence as a lower-risk support space.
- Collection — viable air, viable particulate, and surface samples are logged against their specific location and its alert/action limits.
- Result entry — counts exceeding the alert or action limit for that location are automatically highlighted rather than left for a reviewer to spot manually.
- Trending — the result is added to the location's baseline profile, so a gradual drift shows up before it becomes an excursion.
- Investigation — an exceedance routes into deviation handling, with cleaning and disinfection effectiveness data available as part of the root-cause picture.
- Reporting — the secure web portal gives 24/7 access to sample status, with Excel, Word, and PDF export for the CCS review.
What an Auditor Looks for in an EM Program
An auditor reviewing environmental monitoring is not satisfied by a stack of individually passing results. They are checking whether the program can show a baseline, whether a drift toward the alert limit was caught before it hit the action limit, and whether every exceedance has a documented investigation attached to it rather than a note that it was "reviewed and closed."
Cleantrol EM's data visualization dashboard tracks and displays the KPIs an auditor asks for directly, and its instant trending view is built specifically to show whether a facility is drifting from its normal operating parameters, which is the evidence a CCS review depends on.
Cleantrol EM Across the CORPEX Quality System
Environmental data on its own is only half the picture.
Cleantrol EM sits alongside the CORPEX LIMS software family and shares its microbial counting logic with MicroLIMS, so a viable count taken in the cleanroom and a sterility result on the batch it protects can be reviewed against the same timeline. When a location breaches its action limit, Cleantrol routes the exceedance into deviation management for investigation, and where the root cause points to a process or procedural change, that flows into CAPA rather than being closed as a one-off.
Because an EM system is itself a GxP tool, CORPEX pairs Cleantrol deployments with computer system validation so the sampling logic, limit configuration, and reporting outputs are validated against the facility's own specifications, not a generic default.
Cleantrol EM for Egyptian Cleanrooms
Egyptian pharmaceutical manufacturers registered with the Egyptian Drug Authority (EDA) are held to the same environmental monitoring expectations as any GMP facility, and EGAC-accredited labs supporting them work to ISO/IEC 17025. Both expect trended, defensible EM data rather than a binder of individually initialed sample slips.
As a CORPEX product, Cleantrol EM ships with Arabic and English support and local implementation across Egypt. See our LIMS software for Egyptian laboratories page for how CORPEX scopes EM alongside microbiology and QC testing.
Cleantrol EM — Frequently Asked Questions
What is Cleantrol EM?
Cleantrol EM is CORPEX's environmental monitoring software for controlled environments. It manages sampling of viable air, viable particulates and surface viables, schedules monitoring through an interactive calendar, and trends results against alert and action limits by location.
Does Cleantrol EM support EU GMP Annex 1?
Yes. Cleantrol EM's risk-based sampling, alert/action limit trending and cleaning-and-disinfection effectiveness tracking map directly onto the contamination control strategy that the 2022 revision of EU GMP Annex 1 expects manufacturers to document and maintain.
What does Cleantrol EM monitor?
Cleantrol EM monitors viable air, viable particulates and surface viables across controlled environments, and supports assessment of cleaning and disinfection effectiveness alongside the counts themselves.
How does alert and action limit trending work in Cleantrol EM?
Cleantrol EM records each viable count against the alert and action limit set for its specific location, automatically highlights samples that exceed those limits, and builds the trend view an EM program needs to catch a drift before it becomes an excursion.
Does Cleantrol EM connect to deviation management?
Yes. Cleantrol EM handles deviations arising from environmental monitoring as part of its workflow, so a limit exceedance is routed for investigation rather than left as an isolated flagged result.
Is Cleantrol EM available for Egyptian pharmaceutical and food plants?
Yes. As a CORPEX product, Cleantrol EM ships with Arabic and English support and local implementation across Egypt. See our LIMS software for Egyptian laboratories page.
Take Control of Your Environment
Contact us to see how Cleantrol EM can secure your critical spaces.
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