Temperature and relative humidity (RH) can affect the quality, stability, and integrity of pharmaceutical products, biologics, and other temperature-sensitive materials. Understanding how these conditions vary throughout a controlled environment helps organizations maintain appropriate storage conditions and support GMP compliance.
SOKOL GxP Services provides mapping and qualification studies for temperature-controlled environments, from stability chambers and incubators to controlled room temperature (CRT) areas, GMP warehouses, and distribution centers. Our mapping capabilities include temperature, relative humidity, and CO₂ monitoring, so humidity can be built into a study wherever your products or quality requirements call for it.
Our studies combine risk-based methodologies, robust data analysis, and comprehensive documentation, aligned with your qualification strategy and quality requirements.
Why Humidity Mapping Matters for GxP Storage
Temperature is not the only factor that influences product stability. Relative humidity can affect pharmaceutical materials, packaging components, and products with specific moisture requirements.
Humidity mapping evaluates how RH varies across a controlled environment over a defined period. The results help determine whether conditions remain within specified limits throughout the storage area.
Humidity mapping helps organizations:
Protect product quality: Identify areas where humidity conditions could affect product stability or integrity.
Identify environmental variations: Assess humidity differences across rooms, chambers, and warehouses.
Support stability studies: Characterize environmental conditions in pharmaceutical stability testing environments.
Support GMP compliance: Document environmental performance for qualification activities and regulatory inspections.
Inform monitoring strategies: Use study findings to help determine appropriate locations for ongoing humidity monitoring.
For products with defined RH storage requirements, temperature data alone may not provide a complete picture of environmental performance.
How Humidity Mapping Differs from Temperature Mapping
Temperature and humidity mapping involve different measurement considerations. Sensor placement, calibration, acceptance criteria, and environmental variability must all be considered when designing a study.
Sensor Count and Placement
Temperature and humidity sensors do not always need to be deployed in equal numbers. Depending on the environment, study objectives, and risk assessment, a mapping study may use fewer RH sensors than temperature sensors.
However, fewer measurement points require a clear, documented rationale. The protocol should explain why the selected RH sensor locations adequately characterize humidity conditions throughout the space, including locations where RH is not measured directly. This helps demonstrate how the study addresses environmental risks and supports review by quality teams and auditors.
RH Sensor Calibration and Verification
Reliable humidity mapping depends on suitable instrumentation and documented calibration controls. Calibration certificates and intervals should be reviewed before the study to confirm that sensors meet the required measurement range and accuracy.
Post-study verification should follow the approved protocol and applicable quality procedures, and sensor specifications should be appropriate for the study's acceptance criteria.
Acceptance Criteria for Relative Humidity
RH acceptance criteria should be established before the study begins. Limits depend on product labeling, stability protocols, storage requirements, and the intended use of the environment.
Results are evaluated against the defined criteria to identify out-of-range readings, assess environmental variation, and determine whether further investigation is required.
Seasonal Humidity Variations
Outdoor conditions, HVAC operation, air circulation, and building characteristics can influence indoor humidity. Seasonal changes are particularly relevant to large warehouses and ambient storage areas.
Where seasonal variation presents a risk, studies under different operating conditions can help characterize environmental performance throughout the year.
Environments We Map
Stability Chambers
Stability chambers maintain defined environmental conditions for pharmaceutical stability studies. Mapping evaluates conditions throughout the chamber, including empty and loaded chamber evaluations, open door and recovery studies, and variations between monitoring locations.
ICH Q1A(R2) includes commonly used stability testing conditions such as 25°C/60% RH, 30°C/65% RH, and 40°C/75% RH. Applicable conditions depend on the study protocol.
GMP Warehouses and Distribution Centers
Large storage environments can experience temperature and humidity variations due to building design, HVAC performance, air circulation, and external weather.
Warehouse studies can include seasonal mapping, loading dock impact studies, HVAC performance evaluations, and monitoring probe placement studies. Findings help inform monitoring strategies and identify areas requiring further investigation.
Explore our warehouse temperature mapping services.
Controlled Room Temperature Storage Areas
Mapping evaluates temperature distribution and, where required, relative humidity against defined storage requirements in CRT areas and ambient storage environments. Results help identify environmental variations and support qualification and requalification activities.
Environmental Chambers and Incubators
Mapping evaluates conditions in reach-in and walk-in environmental chambers and incubators used for research, testing, stability programs, and manufacturing support. Where humidity is a controlled parameter, it can be included alongside temperature.
Our Temperature and Humidity Mapping Process
1. Risk Assessment and Scope Definition
We review the environment, intended use, operating conditions, product requirements, and relevant quality documentation.
2. Protocol Development
The protocol defines the methodology, acceptance criteria, monitoring duration, operating conditions, and documentation requirements. SOKOL can deliver a turnkey package using SOKOL-developed methodologies or execute studies in accordance with your client-approved procedures and protocols.
3. Logger Placement and Study Planning
We establish sensor locations based on the environment, study objectives, and relevant risks. The protocol documents the rationale for temperature and RH sensor placement.
4. Study Execution
The study is conducted under agreed operating conditions, including empty or loaded studies and seasonal assessments where required.
5. Data Analysis
We evaluate environmental distribution, identify hot and cold spots, assess humidity variation, and investigate readings outside defined acceptance criteria.
6. Reporting and Recommendations
The final report documents the methodology, findings, and conclusions. Recommendations may address monitoring probe placement, environmental control concerns, or further qualification activities.
Why Choose SOKOL GxP?
GxP and CQV expertise
SOKOL supports commissioning, qualification, and validation activities in regulated life sciences environments, using a risk-based approach to mapping and qualification.
Flexible mapping technology
Our team is trained and experienced with a wide range of wired and wireless mapping systems, and can work with either client-owned mapping equipment and software or SOKOL-provided solutions.
Integrated qualification support
SOKOL offers temperature mapping, CTU qualification, airflow visualization, and broader CQV services, helping clients coordinate related technical activities through one provider.
ISO 9001:2015-certified quality management system
SOKOL's certified quality management system supports a structured approach to service delivery and documentation.
WHERE WE WORK
Temperature & Humidity Mapping Services Across the Northeast and Mid-Atlantic
Based in Bensalem, Pennsylvania, SOKOL GxP Services supports pharmaceutical, biotechnology, and life sciences organizations across the Philadelphia and New Jersey pharmaceutical corridor.
Our service area includes:
Pennsylvania
New Jersey
New York
Maryland
Washington, DC
Massachusetts
Virginia
Multi-region (on request)
