Clean Room Monitoring System: Temperature, Humidity and CO2 for ISO 14644 / GMP Cleanrooms

Cleanroom monitoring usually covers five parameters: temperature, relative humidity, differential pressure between rooms, airborne particle counts and air changes per hour. The last three belong to the HVAC and qualification side of the facility. Ideabytes IoT covers the first two continuously, and adds CO2 where a room or incubator area needs it. The loggers and sensors on this page do not measure differential pressure or particles, and they are not a substitute for the particle counting and pressure cascade checks your classification and requalification depend on.

What they do give you is the continuous, time-stamped temperature and humidity record for every room, with alarms, an audit trail and 21 CFR Part 11 compliant PDF reports, on the same platform that monitors your cold rooms, stability chambers and warehouses.

ISO 14644-1 classifies cleanrooms by the airborne particle concentration permitted per cubic metre, from ISO Class 1 to ISO Class 9, and ISO 14644-2 deals with monitoring to show the room keeps performing. Neither standard sets a temperature or humidity number; those limits are chosen by the facility from the product, the process and operator comfort in gowns, and written into the URS and SOPs. Pharmaceutical cleanrooms typically fall in ISO Class 5 to 8 depending on the operation.

EU GMP Annex 1 and WHO GMP expect an environmental monitoring programme with defined limits, alarms, records and review, and Revised Schedule M in India follows the same direction. In practice, auditors commonly look for a continuous record of temperature and humidity per room, evidence that alarms were raised and acted on, and sensors whose calibration and position have been justified. Treat the statements on this page as guidance and confirm the limits with your QA team.

For a single room, airlock or gowning area, a wall-mounted logger with a built-in sensor is the simplest choice. The IBI-WTH50 (Wi-Fi), IBI-ETH50 (Ethernet) and IBI-MTH50 (4G with in-built M2M SIM) read 0 °C to +50 °C with ±0.5 °C accuracy and 0 to 100 % RH with ±2 % RH accuracy, show live values on a 1.3-inch OLED display, log every 15 minutes by default, hold 90 days of readings on board and run for up to 20 hours on the internal battery if power fails. The IP64 enclosure tolerates routine wipe-down.

Where the logger body must stay outside the classified area, use a probe model such as the IBI-ETH120 or IBI-WTH120: the external temperature and humidity probe is rated from -40 °C to +120 °C with the same ±2 % RH specification, so only the probe passes into the room or the chamber while the display and network connection remain in the corridor or plant room.

A suite of six, ten or twenty rooms is cheaper to wire than to populate with individual loggers. The IBI-A-TH485 is a MODBUS RTU temperature and humidity sensor on an RS-485 bus, measuring -30 °C to +70 °C (±0.3 °C between 0 and 60 °C) and 5 to 95 % RH (±2 % RH between 10 and 90 % RH), with selectable 4800, 9600 or 19200 bps and up to 32 nodes on one line. Daisy-chain the sensors through the suite to one IBI-CSC50R (Wi-Fi) or IBI-CSC50RM (4G) gateway, which reads eight parameters by default and sends them to the cloud.

Each sensor then appears as its own channel with its own limits, alarms and trend graph, and the whole suite is one line of reports for batch review. Sensors must be purchased separately from the gateway, and cable runs can be planned around the pressure cascade so no new penetrations are needed.

Some facilities add CO2 to the room record: cell-culture and incubator rooms, rooms with CO2 incubators or dry-ice handling, and occupied areas where ventilation performance is tracked. The IBI-A-C485 is an NDIR dual-beam CO2 sensor on RS-485 MODBUS RTU, reading 0 to 10,000 ppm with ±(50 ppm + 3 % of reading) accuracy and 1 ppm resolution, for operating temperatures of 0 to 50 °C. It sits on the same RS485 bus and gateway as the temperature-humidity sensors, so CO2 alarms and reports come from the same dashboard. It is a CO2 monitor, not a particle counter.

Rooms are only part of the environmental record. Ovens, autoclave jackets, stability chambers, water baths and cold rooms that feed the cleanroom need their own channels. The IBI-WTR8 (Wi-Fi) and IBI-MTR8 (4G) take eight PT100 or PT1000 probes reading from -200 °C to +550 °C on one unit with a 2.4-inch OLED display and up to 18 hours of battery backup, and report to the same platform as the room sensors, so a single report covers the room and the equipment inside it.

Every channel on the platform carries high and low limits with live alerts and app push notifications, SMS available, and alerts on loss of power or network. Alarms are kept in an alarm log with an audit trail and can be closed with a CAPA entry. Reports are 21 CFR Part 11 compliant PDFs with trend graphs and MKT, generated on demand or on a daily, weekly or monthly schedule for QA review.

Sensor positions should come from a temperature and humidity mapping study rather than convenience, and the installed system should be qualified through IQ, OQ and PQ before the records are relied on. Ideabytes supplies the loggers, sensors, gateways, calibration certificates on request and the reports; the mapping protocol and the qualification are executed by your validation team or partner. See the temperature mapping guide and the IQ OQ PQ guide linked below.