Temperature and humidity mapping studies involve assessing the distribution of temperature and relative humidity across a specific environment, typically for compliance with industry standards and operational safety in controlled environments such as cleanrooms, pharmaceutical facilities, hospitals, warehouses, and cold storage areas. These studies ensure that uniform conditions are maintained to protect both products and processes from temperature or humidity fluctuations that could affect quality, efficacy, or safety.

1. Purpose of Temperature & Humidity Mapping Studies
Verify environmental control systems are maintaining consistent conditions.
Ensure compliance with standards like ISO 14644, FDA cGMP, EU GMP, and USP 797.
Prevent product damage, spoilage, or contamination in temperature- and humidity-sensitive environments.
Document environmental consistency for audits and regulatory reviews.
Optimize HVAC system performance and identify any potential inefficiencies or areas for improvement.

2. Key Parameters Measured in Mapping Studies
Temperature (°C or °F) → Ensures temperature consistency within the controlled space.
Relative Humidity (RH%) → Ensures humidity levels are maintained within specified limits.
Dew Point → Important for preventing condensation in sensitive environments.
Airflow Patterns → Ensures that HVAC systems are providing adequate air circulation and control.

3. Temperature & Humidity Mapping Study Procedure
a. Equipment Required
Data Loggers – Continuous monitoring devices for temperature and humidity over time.
Thermo-Hygrometers – Devices for real-time measurement of temperature and humidity.
Calibration Standards – To ensure measurement accuracy.
Measurement Grid Plan – Defines key locations in the room to place the sensors.
Software for Data Analysis – Used to analyze and present data trends, such as temperature fluctuations and RH variations.
b. Test Steps
Define Study Area
Identify areas where temperature and humidity monitoring is crucial, such as storage areas, cleanroom corners, or equipment zones.
Set up the measurement grid based on the size and layout of the room.
Deploy Sensors/Data Loggers
Distribute temperature and humidity sensors throughout the room in strategic locations (e.g., near walls, corners, air supply, exhaust points, and doorways).
Record baseline conditions before starting the mapping process.
Monitor Over Time
Monitor temperature and humidity continuously over a set period (usually 24 hours to 7 days) to capture both static conditions and variations caused by external factors like HVAC cycling, personnel movement, or equipment operation.
Data Collection & Analysis
Collect data points at regular intervals (e.g., every 5 or 10 minutes).
Analyze the data to identify areas of the room with temperature or humidity inconsistencies.
Use the software to generate contour maps or graphs showing the variations in temperature and humidity across the space.
Review Results
Compare the results with industry standards or internal specifications.
Ensure the conditions remain within the desired range for the application (e.g., 20-25°C and 40-60% RH for cleanrooms or pharmaceutical storage).

4. Pass/Fail Criteria for Temperature and Humidity Mapping
Application
Temperature Range (°C)
Relative Humidity Range (RH%)
Uniformity Tolerance
Cleanrooms (ISO 5-8)
18 – 24
40 – 60
±1°C, ±5% RH
Hospitals (ICUs, Pharmacies)
20 – 24
30 – 60
±1°C, ±5% RH
Pharmaceutical Storage
15 – 25
35 – 65
±2°C, ±5% RH
Cold Storage (Food)
0 – 4
60 – 85
±2°C, ±5% RH
Medical Equipment Storage
20 – 23
30 – 60
±1°C, ±3% RH
Pass: Conditions are within acceptable limits (temperature and humidity).
Fail: Variations exceed the tolerance limits → corrective action required (e.g., HVAC adjustment, equipment replacement, etc.).

5. Corrective Actions for Non-Uniform Conditions
Adjust HVAC systems for improved air circulation and temperature control.
Reposition temperature or humidity sensors to cover weak spots or dead zones in the airflow.
Ensure adequate insulation to prevent heat loss or gain.
Check for equipment failures (e.g., malfunctioning air conditioning units or humidifiers).
Review room design and layout (e.g., poor airflow can cause cold or hot spots).
Install additional air handling equipment (e.g., fans or humidifiers).

6. Applications of Temperature & Humidity Mapping Studies
Cleanrooms & Laboratories → Ensures compliance with environmental standards for contamination control.
Pharmaceutical Manufacturing & Storage → Protects drug stability and efficacy.
Food Processing & Storage → Maintains quality and prevents spoilage.
Hospitals & Medical Equipment Storage → Protects sensitive medical devices and medications.
Cold Chain Management → Ensures temperature-sensitive goods, like vaccines, are stored and transported properly.

Would you like a detailed mapping protocol, software suggestions for data analysis, or further insights into the specific equipment required for these studies?