Uncountable Launches Environmental Monitoring Capability for Manufacturing Plants

Uncountable, the AI platform for end-to-end product development, has launched an environmental monitoring capability for food, beverage, cosmetics, specialty chemicals, and other process manufacturers, as well as pharmaceutical and biotechnology companies that operate classified cleanrooms. Quality teams can map sampling points on their own floor plans, schedule sampling that generates lab requests, and capture photos as supporting evidence, with every result linked to the point, area, and plan that produced it.

An environmental monitoring program depends on knowing where, when, and under what conditions each sample was taken. FDA’s preventive controls rule for human food requires environmental monitoring when ready-to-eat foods are at risk of contamination with an environmental pathogen, such as Listeria monocytogenes. In sterile pharmaceutical manufacturing, the revised EU GMP Annex 1, in effect since August 2023, requires a contamination control strategy that includes cleanroom environmental monitoring.

“Environmental monitoring is one of the first places an auditor looks, and one of the hardest places for a quality team to show a clean trail,” said Julia Turner, Product Manager at Uncountable. “Too often the map lives in a PDF, the schedule lives in a spreadsheet, and the photos live on someone’s phone, so every investigation starts with a reconciliation exercise.”

With Uncountable’s environmental monitoring capability, quality teams upload a floor plan as the site map for each monitoring area, such as a ready-to-eat packing zone or a sterile filling suite, and classify the area by food hygienic zone (1 to 4), EU GMP grade (A to D), or ISO 14644-1 class (5, 7, or 8). Sampling points are placed directly on the map, and the platform supports configured sampling methods such as swab, air, and settle plate.

The team then builds a sampling plan by selecting points on the map and setting a daily, weekly, monthly, or yearly frequency with start and end dates. Once the plan is finalized, the platform schedules every sampling event and can send recurring reminders through configurable notifications. Each event generates a lab request and a sample for every selected point. Cleanroom samples also record whether the room was at rest or in operation.

Technicians open the request for each sampling event on an approved mobile device or in the web platform on a computer, enter sample data, and attach photos taken at collection as supporting evidence of conditions such as visible contamination, an obstruction, or a small change in sampling position. Lab results entered on that request link back to the sampling point and event that produced them.

“Because environmental monitoring runs on the same Uncountable data model as the lab, a result is never a dead end,” said Turner. “Quality teams can query it by area, grade, or plan, and reuse it across the rest of their R&D and quality workflows.”

Results are checked against configurable specification limits that highlight out-of-spec values. When a result needs follow-up, teams can open a quality record in Uncountable’s QMS that is linked to the sample. Records carry audit logs and electronic signatures aligned to 21 CFR Part 11 and EU Annex 11.

Bodie, Uncountable’s AI agent, can answer questions about configured records, such as which locations have had repeated failed checks in the last 30 days, or compare results by location, method, and occupancy state. Bodie can also create a trend chart for each sampling location or summarize attached lab reports and identify records for review.

The capability also works alongside systems a site already runs. Facilities that use an external LIMS can connect it through Uncountable’s API, SDK, or Model Context Protocol (MCP) access, along with telemetry and environmental, health, and safety (EHS) systems.

Video Credit: Uncountable Inc.