The contamination that crept in slowly.

For three months, viable counts in Filling Room 2 showed a gradual upward trend. Each individual result was within limits. Nobody noticed the pattern because nobody was trending—just checking pass/fail.

When the first action limit excursion finally triggered investigation, the contamination had spread. Fourteen batches were in quarantine. Root cause analysis pointed to a HVAC filter that had been degrading for months. The trend was visible in hindsight. It should have been visible in real time.

Facility mapping that shows the whole picture

Environmental monitoring isn't a list of sample results. It's a spatial understanding of your facility's microbial state.

Seal displays your facility as a map. Sampling locations are points on that map. Current status—last result, trend direction, alert state—is visible at a glance. Click a location to see history. Zoom out to see the whole facility. Zoom in to see a single room.

When contamination appears, you see where. When trends develop, you see the pattern spreading or contained.

Scheduling that accounts for production

Sample during production, not during shutdown. Sample high-traffic times, not empty rooms. But also sample consistently enough to trend.

Seal generates sampling schedules based on your monitoring plan—locations, frequencies, sampling conditions. The schedule accounts for production calendar. Operators see what's due today, this shift, right now. Missed samples are flagged immediately, not discovered during monthly review.

Alert and action limits that mean something

Grade A: less than 1 CFU. Grade B: less than 10 CFU. But what about Grade B trending from 2 to 5 to 8 over three months? Still within limits. Still a problem.

Seal maintains both static limits and trend-based alerts. A single result triggers action limit response. A pattern of increasing results—even within limits—triggers trend alert. You define the statistics: moving average, standard deviation, regression slope. The system watches continuously.

Excursion investigation with context

An action limit excursion happens. Now what? In most systems: open a deviation, manually gather information, try to figure out what happened.

Seal opens the investigation with context populated. What was happening in that room? What batches were in process? What personnel were present? What was the HVAC status? What were the results at adjacent locations?

The investigation starts with facts assembled, not data hunting.

Organism identification and trending

Knowing the count isn't enough. Knowing the organism tells you where it came from.

Seal tracks organism identification at species level. Trend by organism type—are you seeing the same Staphylococcus epidermidis in the same location? That's a reservoir. Are you seeing diverse organisms sporadically? That's probably personnel-associated.

Organism tracking turns counts into intelligence.

Integration with batch release

Environmental results affect batch release decisions. If viable counts were elevated during filling, can you release the batch?

Seal links EM results to batch records automatically. When reviewing a batch for release, you see the environmental conditions during manufacturing—not a separate report someone has to request, but data that's part of the batch record.

Elevated EM results during production trigger automatic quality review before batch can progress.

Continuous monitoring integration

Viable particle counters, non-viable particle counters, temperature sensors, humidity sensors, differential pressure monitors—all generating continuous data streams.

Seal integrates with monitoring equipment. Data flows automatically. Excursions trigger alerts in real time—not when someone reviews the data logger next week.

Annex 1 compliance built in

EU Annex 1 revision raised requirements for contamination control strategy. Risk assessment, monitoring program justification, trending, and contamination control strategy documentation.

Seal provides the framework. Document your contamination control strategy. Link monitoring locations to risk assessment. Generate compliance reports showing monitoring effectiveness. When inspectors ask about your Annex 1 approach, show them the system.