Uncountable has launched an environmental monitoring capability for manufacturing facilities, including pharmaceutical and biotechnology sites operating classified cleanrooms.
The new functionality allows quality teams to map sampling locations directly onto facility floor plans, schedule recurring sampling programmes and generate laboratory requests automatically.
Julia Turner, Product Manager at Uncountable, told Cleanroom Technology that the capability was developed to address the fragmentation of environmental monitoring (EM) data across pharmaceutical manufacturing facilities.
Sampling schedules are often held in spreadsheets or standalone EM systems, while laboratory results, batch records, deviation logs and maintenance records are stored separately.
"Quality teams can show that monitoring took place. What they struggle to show is what the data means for product risk, or how it connects to decisions made earlier in development," Turner said.
The requirements of EU GMP Annex 1 have increased the need for manufacturers to connect this information.
Quality teams can show that monitoring took place. What they struggle to show is what the data means for product risk, or how it connects to decisions made earlier in development
The regulation, which came into effect in August 2023, requires sterile manufacturers to maintain a holistic Contamination Control Strategy (CCS), supported by risk-based environmental monitoring and regular reviews.
"The revised EU GMP Annex 1 made that gap harder to live with. It requires manufacturers to maintain a holistic Contamination Control Strategy (CCS), justify sampling locations through risk assessment, trend EM results over time rather than only reacting to excursions, and show that the CCS is reviewed and improved continuously," Turner said.
The revised EU GMP Annex 1 made that gap harder to live with
Under Uncountable's new capability, users can upload floor plans for individual monitoring areas, such as sterile filling suites, and classify them according to EU GMP grades A to D or ISO 14644-1 cleanroom classes.
Sampling points can then be placed directly onto the site map, with configurable sampling methods including swabbing, air sampling and settle plates.
Quality teams can create sampling plans by selecting locations and setting monitoring frequencies, ranging from daily to yearly, alongside start and end dates.
The platform automatically schedules sampling events and generates a laboratory request and sample record for each selected point.
Configurable notifications can also provide reminders for upcoming sampling activities.
Technicians can access sampling requests through an approved mobile device or the web platform, where they can enter collection data and attach photographs documenting conditions at the time of sampling.
For cleanroom monitoring, records can also capture whether the room was at rest or in operation.
Laboratory results are linked to the sampling point and event that generated them, allowing quality teams to review results by location, area, cleanroom grade or monitoring plan.
The platform checks results against configurable specification limits and highlights out-of-specification values.
Where further investigation is required, users can open a linked quality record through Uncountable's quality management system (QMS).
Environmental monitoring results can also be connected to nonconformance and corrective and preventive action (CAPA) records, as well as relevant batches, materials, equipment and personnel training records for the affected area and time period.
This allows investigators to access relevant information without manually retrieving records from multiple systems.
Quality teams can also examine potential relationships between contamination patterns, manufacturing processes and formulation variables.
"Over time, quality teams can trend EM performance across rooms, sites and processes, and relate contamination patterns to process and formulation variables. That evidence feeds back into the Contamination Control Strategy and into development decisions upstream," Turner said.
The platform includes an audit trail capturing changes to records, which are archived rather than deleted.
It is also supported by GxP validation documentation, with audit logs and electronic signatures designed to support compliance with 21 CFR Part 11 and EU GMP Annex 11.
"When an inspector asks how the CCS is monitored, reviewed and improved, manufacturers can show a single, traceable chain from the cleanroom to the product, not a collection of disconnected reports," Turner said.
AI-powered environmental monitoring
Uncountable's AI agent, Bodie, can query environmental monitoring records, identify locations with repeated failed checks and compare results by sampling method, location and occupancy state.
The agent can also generate trend charts for individual sampling locations and summarise attached laboratory reports for review.
The capability can be integrated with existing facility systems, including external laboratory information management systems (LIMS), through Uncountable's application programming interface (API), software development kit (SDK) or Model Context Protocol (MCP) access.
The platform also supports connections with telemetry and environmental, health and safety (EHS) systems.
