Temperature and Humidity Logs

Temperature and relative humidity (RH) are critical environmental parameters in a sterile compounding facility. USP 797 specifies that cleanroom areas must maintain defined temperature and humidity ranges to support aseptic processing conditions, prevent microbial growth, and ensure the stability of in-process materials. Logging these readings systematically — at regular intervals, by trained staff, using calibrated instruments — is both a regulatory requirement and a practical quality control measure. Clarix provides a dedicated logging interface for temperature and humidity readings, with automatic out-of-range flagging and a complete searchable history.

Navigate to Environmental → Temperature & Humidity to access the T&H log.

Acceptable ranges per USP 797

USP 797 and supporting guidance documents specify the following general environmental conditions for classified cleanroom areas:

Your facility's specific SOPs may define tighter ranges than the USP defaults. The ranges configured in Clarix reflect your facility's validated and approved specifications. Any reading outside those ranges will be flagged as out-of-range in the system.

Typical facility SOPs for sterile compounding specify:

• Temperature: 18–23°C (allowing for seasonal variation while maintaining a comfortable working environment that does not promote sweating)
• Relative Humidity: 30–60% RH (with anything above 60% flagged as a potential mold risk)

Recording a temperature and humidity reading

1. Navigate to Environmental → Temperature & Humidity.
2. Click New Reading.
3. Select the Room from the dropdown. Only rooms configured in the Facility module with temperature and humidity monitoring requirements will appear in this list.
4. Enter the Temperature (°C) — the measured temperature. Use the actual reading from the instrument, not an approximated or rounded value.
5. Enter the Relative Humidity (%) — the measured RH value.
6. Enter the Date and Time of the reading. This should be the actual measurement time, not the time of data entry. For manual log-sheet entries being transferred to Clarix, enter the time from the paper log.
7. Enter the Instrument ID — the asset tag of the thermometer or datalogger used to take the reading (e.g., EQ-0022 — Digital Thermo-Hygrometer, ISO 7 Buffer Room). Using a calibrated, identified instrument is required; this field links the measurement to the instrument's calibration record.
8. Add any Notes if relevant — for example, if a reading is near the limit and corrective action was taken, or if the HVAC system was being serviced nearby at the time.
9. Click Save Reading.

The system immediately evaluates the temperature and humidity values against the configured acceptable ranges for that room. If either value is out of range, the reading is flagged with an out-of-range indicator and a notification is sent to the QA role.

Out-of-range readings

When a reading is flagged as out of range:

• The row is highlighted in the T&H log list
• A notification is sent to QA staff
• The system prompts for a corrective action note

For out-of-range readings, you should document:

• When the out-of-range condition was first noticed and when it was corrected
• What corrective action was taken (e.g., HVAC adjusted, thermostat rechecked, unit cleaned)
• Whether any compounding was occurring during the out-of-range period, and if so, whether a formal deviation report or product impact assessment is required

Persistent or severe out-of-range conditions (particularly RH above 60%) should be escalated to facilities management and may require a formal CAPA.

Manual vs. automated datalogger entry

There are two ways temperature and humidity data can be recorded in Clarix:

Manual entry

A technician reads the values from a wall-mounted display, portable thermometer, or printed datalogger report and enters them into Clarix. This is appropriate for facilities using simple digital instruments without network connectivity. The advantage of manual entry is simplicity; the disadvantage is the possibility of transcription error and gaps if staff forget to log readings.

Automated / imported entry

Facilities using networked dataloggers or building management systems (BMS) may be able to export readings in a structured format and import them into Clarix in bulk. Contact your system administrator or Clarix implementation team to configure automated data transfer for your monitoring equipment.

Regardless of method, all readings — whether entered manually or imported — are stored with the same level of traceability: room, instrument, value, timestamp, and entering user.

Log history and trend review

The T&H log list displays all readings in reverse chronological order. Filters allow you to:

• Select a specific room
• Set a date range
• View only out-of-range readings

For trend analysis, the T&H chart view plots temperature and humidity over time for a selected room, making it easy to identify drift, seasonal trends, or correlations between environmental fluctuations and microbial excursions.

Why temperature and humidity records matter

During FDA inspections, temperature and humidity logs are frequently requested as part of the broader environmental monitoring program review. Gaps in the log — days or shifts with no readings — are a finding, especially if product was compounded during that period. Out-of-range readings that were not investigated or documented are also significant. Maintaining a complete, current T&H log demonstrates that your facility's environmental monitoring program is functioning as intended.

Role required: All production staff can log temperature and humidity readings. QA and Admin can configure acceptable ranges and manage out-of-range notifications.

Related pages

• Environmental Monitoring Overview
• EM Sampling
• Excursions
• Equipment Calibration
• Facility Overview