ATEK thermal mapping study

Thermal Mapping

GxP-compliant thermal mapping services for pharmaceutical warehouses, cold rooms, stability chambers, and controlled storage areas. WHO and GDP compliant protocols.

Mapping Studies

Comprehensive thermal characterization for every environment

Warehouse Mapping

Comprehensive thermal mapping of pharmaceutical warehouses and distribution centers.

  • Pharmaceutical distribution
  • Cold chain facilities
  • Ambient storage

Cold Room Mapping

Temperature distribution studies for walk-in coolers, freezers, and cold rooms.

  • 2-8°C storage
  • Frozen storage
  • Controlled temp rooms

Stability Chamber Mapping

Qualification mapping for stability chambers supporting ICH guidelines.

  • ICH stability studies
  • Photostability chambers
  • Climatic chambers

Incubator Mapping

Temperature uniformity studies for incubators and environmental chambers.

  • CO2 incubators
  • BOD incubators
  • Environmental chambers

Our Mapping Process

Structured approach to thermal characterization

1

Planning

Review facility, define scope, and develop mapping protocol.

2

Sensor Placement

Position calibrated sensors according to protocol requirements.

3

Data Collection

Monitor conditions for required duration (typically 24-72 hours).

4

Analysis

Analyze data, identify hot/cold spots, and calculate MKT if required.

5

Reporting

Deliver GxP-compliant report with recommendations.

Comprehensive Deliverables

ATEK thermal mapping studies include complete documentation packages that satisfy regulatory requirements and support your qualification activities.

  • GxP-compliant mapping protocol
  • Sensor placement diagram
  • Calibration certificates
  • Raw data files
  • Statistical analysis
  • Temperature distribution maps
  • Hot/cold spot identification
  • MKT calculations (if applicable)
  • Compliance assessment
  • Final mapping report

Temperature Distribution

Identify hot & cold spots

Regulatory Compliance

WHO
Guidelines
FDA
Compliance
EU GDP
Compliant
Health Canada
Requirements
ICH
Stability
1000+
Mapping Studies
150+
Facilities Mapped
NIST
Traceable Sensors
GxP
Compliant Reports

Frequently Asked Questions

What is thermal mapping?

Thermal mapping is a study to characterize temperature distribution within a controlled environment. It identifies hot and cold spots, verifies temperature uniformity, and demonstrates that storage conditions meet regulatory requirements.

How long does a mapping study take?

Most mapping studies require 24-72 hours of continuous data collection. The total project timeline, including planning and reporting, typically ranges from 1-3 weeks depending on facility size and complexity.

When should thermal mapping be performed?

Thermal mapping should be performed during initial qualification, after significant HVAC changes, following layout changes that affect airflow, and periodically (typically annually) to demonstrate ongoing compliance.

What regulations require thermal mapping?

WHO, FDA, EU GDP, Health Canada, and various pharmacopeial guidelines require thermal mapping of pharmaceutical storage areas. ATEK mapping studies are designed to meet these regulatory requirements.

Need a Thermal Mapping Study?

Contact us to discuss your facility requirements and receive a customized mapping proposal.