Temperature Mapping in Kenosha

What Is Temperature Mapping

Temperature mapping is the process of measuring and documenting the temperature distribution throughout a storage area, warehouse, cold room, or controlled environment over a defined period of time. The purpose of a temperature mapping study is to identify hot spots and cold spots within the storage space, verify that all locations within the usable storage area maintain temperatures within specified limits, and characterize the spatial and temporal temperature variations caused by HVAC systems, door openings, seasonal conditions, solar loading, and product loading.

Temperature mapping is required by regulatory agencies and quality standards for any facility storing temperature-sensitive products — including pharmaceutical raw materials, finished drug products, biological products, vaccines, clinical trial materials, food ingredients, and temperature-controlled chemicals. The FDA, WHO, and ICH guidelines all require documented evidence that storage areas maintain appropriate temperature conditions. A properly conducted mapping study provides this evidence and establishes the foundation for ongoing temperature monitoring programs.

Mapping studies are categorized as empty-chamber studies (performed with the storage area empty to characterize the baseline thermal profile) and loaded-condition studies (performed with representative product loads to assess the impact of thermal mass on temperature distribution). Both types are typically required for initial qualification, and seasonal re-qualification studies are performed to account for the impact of ambient temperature extremes on the storage environment.

The Temperature Mapping Process

Step 1: Site Assessment and Protocol Development

A thorough assessment of the storage facility is conducted prior to sensor placement. Facility dimensions, HVAC system configuration, door locations, loading dock proximity, exterior wall orientation (solar exposure), racking layout, and product storage patterns are evaluated. A written mapping protocol is developed specifying sensor locations, study duration, recording intervals, acceptance criteria, and the conditions to be tested (empty, loaded, summer, winter). The protocol is reviewed and approved prior to execution.

Step 2: Sensor Placement

NIST-traceable calibrated temperature sensors (data loggers or wired sensors connected to a data acquisition system) are placed at defined grid positions throughout the storage area. Sensors are positioned at multiple heights (floor level, mid-height, ceiling level) and distributed horizontally to cover all areas of the storage space including locations near doors, exterior walls, HVAC supply and return vents, loading docks, and the geometric center of the space. WHO TRS 961 Annex 9 recommends a minimum of one sensor per 20 cubic meters for small facilities and proportionally more for larger warehouses. Corner and edge positions are always included.

Step 3: Data Collection

Temperature data is recorded continuously at regular intervals (typically every 1 to 5 minutes) for the duration of the mapping study. The minimum study duration is typically 24 to 72 hours for each condition tested, although WHO guidelines recommend a minimum of 3 consecutive days for warehouse qualification. During the study, normal operational conditions are maintained — including HVAC operation, door openings, personnel access, and product handling — to capture the temperature variations that occur during routine facility use. Extreme ambient conditions (hottest and coldest periods) should be captured for comprehensive seasonal qualification.

Step 4: Data Analysis and Hot/Cold Spot Identification

The recorded temperature data is analyzed to determine the mean, minimum, maximum, and standard deviation at each sensor location. Hot spots (locations consistently at the highest temperatures) and cold spots (locations consistently at the lowest temperatures) are identified. The mean kinetic temperature (MKT) may be calculated for each sensor location when required by pharmaceutical storage guidelines. Temperature excursions — periods when any sensor location exceeds the specified storage limits — are identified, documented, and evaluated for duration and magnitude. Isotherm maps or spatial temperature profiles may be generated to visualize the temperature distribution.

Step 5: Reporting and Qualification

A comprehensive temperature mapping report is issued under ISO/IEC 17025 accredited laboratory scope. The report includes the mapping protocol, sensor placement diagrams with identified positions, complete data summaries for each sensor location, hot spot and cold spot identification with coordinates, temperature distribution maps, excursion analysis (if any), MKT calculations (when applicable), comparison of results against acceptance criteria, measurement uncertainty statements, reference standard traceability documentation, and recommendations for ongoing monitoring sensor placement based on the identified hot and cold spots.

Compliance & Standards

WHO TRS 961 Annex 9 — Temperature Mapping of Storage Areas

The World Health Organization Technical Report Series 961, Annex 9 provides detailed guidance on the qualification of storage areas for pharmaceutical products. It specifies requirements for temperature mapping studies including sensor density, study duration, conditions to be tested, and documentation requirements. WHO Annex 9 is widely adopted as the reference standard for pharmaceutical warehouse qualification globally.

FDA 21 CFR Parts 210/211 — Pharmaceutical cGMP

FDA cGMP regulations require that drug products be stored under appropriate conditions of temperature and humidity. Section 211.142 requires adequate storage space under appropriate conditions. While the FDA does not prescribe a specific mapping methodology, compliance with cGMP requires documented evidence that storage areas maintain temperatures within labeled storage conditions for all pharmaceutical products.

ICH Q1A(R2) — Stability Testing

ICH guidelines define storage conditions for stability testing of pharmaceutical products, which in turn define the temperature limits that storage areas must maintain. Long-term storage at 25 degrees C plus or minus 2 degrees C, intermediate storage at 30 degrees C plus or minus 2 degrees C, and refrigerated storage at 5 degrees C plus or minus 3 degrees C are standard ICH conditions. Temperature mapping verifies that storage areas consistently maintain these conditions.

Additional Standards

• ISO/IEC 17025 — General requirements for the competence of testing and calibration laboratories
• GDP (Good Distribution Practice) guidelines — Temperature-controlled storage and distribution requirements
• USP <1079> — Good storage and distribution practices for drug products
• PDA Technical Report No. 39 — Guidance for temperature-controlled medicinal products: cold chain guidance
• EU GMP Annex 15 — Qualification and validation
• Health Canada GUI-0069 — Guidelines for temperature control of drug products during storage and transportation

Industry Applications

Pharmaceutical Warehouses

Temperature mapping of ambient, controlled room temperature (CRT), refrigerated (2-8 degrees C), and frozen (-20 degrees C) pharmaceutical storage areas is performed for FDA cGMP compliance, WHO prequalification, and international regulatory submissions. Mapping studies support the qualification of new facilities and the requalification of existing storage areas after HVAC modifications or seasonal transitions.

Cold Chain Distribution Centers

Mapping of cold storage facilities, cross-dock operations, and temperature-controlled distribution centers used in pharmaceutical and food supply chains is performed to qualify refrigerated and frozen storage zones, staging areas, and loading dock environments. GDP compliance requires documented temperature mapping for all storage areas handling temperature-sensitive products.

Food & Beverage Storage

Temperature mapping of dry goods warehouses, refrigerated storage, frozen storage, and blast freezer facilities is conducted to support FSMA, HACCP, and SQF requirements. Documented temperature control in food storage environments is mandated by these standards. Mapping identifies areas that may not maintain required temperatures during seasonal extremes or peak loading conditions.

Clinical Trial Material Storage

Qualification of storage areas for investigational drug products, biological specimens, and clinical trial supplies is performed to meet strict temperature control requirements (often 2-8 degrees C or -20 degrees C) with narrow tolerances. Mapping documentation is included in regulatory submission dossiers and is subject to sponsor audit and regulatory inspection.

Temperature Mapping in Kenosha

On-site temperature mapping is performed at pharmaceutical warehouses, cold chain distribution centers, food storage facilities, and controlled environment storage areas in Kenosha and the surrounding Wisconsin area. Qualification protocols, sensor placement, data collection, and analysis are conducted by ISO/IEC 17025 accredited laboratories using NIST-traceable calibrated temperature sensors and data acquisition equipment. All mapping reports are issued on-site upon completion of the measurement work.

Facilities in Kenosha, WI requiring temperature mapping for pharmaceutical storage qualification, FDA compliance, WHO prequalification, or food safety requirements are served through Temperature Calibration Specialists. Standard and priority scheduling is available.