Monitoring in GMP production
Temperature, humidity and differential pressure in production areas, cleanrooms, airlocks and intermediate storage. Measured continuously, alarmed in time and logged in an audit trail that cannot be altered.
What needs to be monitored in GMP production?
The parameters that can affect product quality. In practice that means temperature and humidity in production areas and storage, differential pressure between cleanroom zones and airlocks, and temperature in process equipment and intermediate storage. The measurements must be continuous, alarmed and traceable to an accredited calibration.
The scope is set in your own risk assessment. We advise on sensor placement, but the decision on what to monitor is yours.
What we monitor in production
Cleanrooms and pressure cascades
Differential pressure between zones, airlocks and isolators. One or two channels per sensor, so an entire cascade can be followed.
Differential Pressure Smart-SensorRead about cleanrooms →
Production areas
Temperature and humidity in the room itself. Humidity is often what degrades the product, long before temperature does.
Temperature and humidity sensor
Intermediate storage and cold rooms
Raw materials and intermediates under GMP. Several measuring points per room, typically following a mapping study.
Emerald Bluetooth sensor + Cobalt XRead about cold rooms and storage →
Stability chambers
Temperature and humidity over long periods. A gap in the curve means an invalid study.
Temperature and humidity sensorRead about QC laboratories →
Process equipment
Autoclaves, drying ovens and heating cabinets up to 200 degrees. Pt100 is specified for the full range.
Pt100 Smart-Sensor
Third-party equipment
Particle counters, oxygen meters and cell production equipment such as CliniMACS Prodigy via 4-20 mA or 0-10 V.
Universal Smart-SensorRead about third-party equipment →No cables through GMP walls
A cable penetration in a cleanroom wall is a change that has to be documented. With wireless, you avoid that discussion.
Bluetooth
Sensor to data logger
Used for the sensing. The sensor sits inside the equipment or behind the zone and sends to the logger without a cable.
LoRaWAN
Data logger to gateway
From here the signal is passed on. One gateway handles up to 50 data loggers and 100 to 200 sensors.
Wi-Fi
Smaller installations and fast logging
Cobalt XS Wi-Fi for smaller installations, or when a logging interval faster than 1 minute is needed.
The deviation is caught before it becomes a deviation report
Via OCEAlert, the relevant staff are notified by call, SMS or email. If they do not answer, it moves down the on-call rota until someone acknowledges. Everything is logged.
Equipment and location
Every device linked to a department and room, so the alarm points to a place and not a serial number.
The certificate in the system
The calibration certificate is retrieved directly on the sensor. The system shows what needs calibrating, based on the intervals you have defined.
Limits with delay
Three levels up and three down. Each limit has its own delay, so an airlock in use does not trigger an alarm.
The documentation your QA asks for
We deliver the system and handle the validation, alone or in close cooperation with your QA.
Audit trail
Every reading, every alarm, every acknowledgement with timestamp and user. Cannot be altered.
Traceable certificates
The certificate is retrieved directly on the sensor in OCEAView.
Report in one click
Choose a period, export the report as PDF or CSV.
Requirements we support
GMP, GDP, EU GMP Annex 11, FDA 21 CFR Part 11 and ALCOA.
Compliance for pharma and hospitals, explained in plain English
The rules rarely say "buy a monitoring system". They say that conditions must be under control and documented. Here is what that means in practice.
GMP
Good Manufacturing Practice
Requires the conditions that affect product quality to be under control. In practice: measurement around the clock, alarms on deviation and a log that can be presented.
Applies to production and QCGDP
Good Distribution Practice
Requires medicines to be stored and transported within their temperature window. Mapping documents that the whole room holds, not just the middle.
Applies to storage and transportEU GMP Annex 11
Computerised systems
Requires the system to be validated, data to be unalterable without a trace, and access to be controlled. We carry out the validation, alone or together with your QA.
Applies to the software itself21 CFR Part 11
Electronic records
US requirement for electronic signatures and audit trail. Relevant if you export to the USA or work for an American parent company.
Applies to exports to the USAWhere is the line between us and you?
We deliver the system, the documentation and the validation itself: audit trail, traceable calibration certificates, timestamped readings and reports, and IQ, OQ and PQ carried out by us, alone or in close cooperation with your QA. You set the scope based on your own risk assessment.
Validation: who does what →Case
Tappecenter Kolding
See how Tappecenter Kolding has set up monitoring and alarms so that a deviation reaches the right person, also outside working hours.
Read the full case24/7
alarms with escalation
Frequently asked questions
Can the sensors sit in a cleanroom?
Yes. The sensors are small and can be cleaned. The data logger can sit outside the zone, so only the sensor is inside the room.
Do we need to break through the wall to run cables?
No. The sensor talks Bluetooth to the data logger, and the data logger talks LoRaWAN to the gateway. No penetration of zones.
How do we avoid false alarms when an airlock is in use?
Each alarm limit can have its own delay. The limit must be exceeded for the number of minutes you decide before the alarm goes off.
Can we monitor our particle counter in the same system?
Yes. Universal Smart-Sensor reads 4-20 mA, 0-5 V and 0-10 V, so third-party equipment sits in the same dashboard as everything else.
Who handles the validation?
We do, alone or together with your QA. You set the scope, and we carry out the validation and deliver the documentation.
Are FMS and EMS the same?
Yes. Facility Monitoring System and Environmental Monitoring System cover the same thing. The only difference is which term the industry uses.
Other areas in pharma
Same system, different requirements. See how we monitor the rest of the chain.
Cleanrooms and pressure cascades
Differential pressure between zones and airlocks with a delay per alarm level.
Read more →GMP storage and distribution
Raw material storage, finished goods storage and cold rooms under GMP and GDP.
Read more →
QC laboratories
Stability chambers, refrigerators and freezers without gaps in the curve.
Read more →Kom hurtigt i kontakt med den rette specialist.
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