Controlled Environments and Critical Equipment

Click here for the Temperature Mapping Services Cut Sheet

Temperature Mapping Services for Storage and Distribution Center

At CellSpark, we provide comprehensive temperature mapping and thermal validation services tailored to meet the compliance needs of pharmaceutical, biotech, and life sciences operations. Whether you’re qualifying a massive distribution warehouse or a high-performance freezer, our team ensures your facility and equipment meet regulatory expectations, internal quality standards, and product safety requirements.
We deliver end-to-end solutions for:

  • Warehouses & Distribution Centres (including high bay and multi-zone structures)
  • Cold Storage Rooms and Chambers
  • Refrigerated Vehicles & Transit Systems
  • Controlled Room Temperature (CRT), 2-8°C, and -20°C Environments
  • Stability Chambers and Conditioning Zones

Scope of Work Includes:

  • Risk-based mapping plan and protocol development
  • Strategic placement of calibrated data loggers based on airflow, volume, and risk zones
  • Study execution for:

    • Empty state (OQ)
    • Loaded state (PQ)
    • Door opening recovery, power failure simulations, seasonal stress studies
  • Data analysis, deviation investigation, and worst-case zone identification
  • Final validation report with mapping layouts, temperature trend graphs, and regulatory references
  • Periodic requalification schedules

Thermal Equipment Qualification

We have deep expertise in temperature mapping of:

  • Freezers (-20°C, -40°C, -80°C)
  • Ultra-Low Temperature (ULT) Freezers
  • Cold Storage Units
  • Incubators (30–37°C and custom profiles)
  • Autoclaves and Steam Sterilizers (gravity displacement, pre-vacuum, porous load)
  • Heating Blocks, Water Baths, and Dry Heat Chambers

Our Qualification Approach Covers:

  • Design Qualification (DQ) review based on specifications and intended use
  • Installation Qualification (IQ) for utility connections, chamber integrity, and sensor calibration
  • Operational Qualification (OQ) to verify uniformity, accuracy, and alarm functions
  • Performance Qualification (PQ) using actual load configurations and challenge cycles
  • Temperature uniformity, heat distribution, and cold spot identification
  • Sterilization verification using biological indicators (for autoclaves)
  • Documentation of cycle reproducibility, hold times, and alert/action limit compliance

Documentation & Compliance

We provide the following documentation deliverables to support regulatory compliance and audit readiness:

  • Validation Plans & Protocols (IQ/OQ/PQ)
  • Calibration Certificates for all sensors and instruments
  • Equipment Layouts and logger position maps
  • Comprehensive Final Reports with summary of findings and recommendations
  • Standard Operating Procedures (SOPs) for future monitoring and excursions
  • Compiled and audit-ready binder in alignment with Health Canada, FDA, EMA, WHO, ICH Q1A, and ISPE guidelines
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