Regulatory-Compliant Environmental Qualification for Pharmaceutical and Medical Facilities

We provide comprehensive temperature mapping and validation services for temperature-controlled environments used in pharmaceutical manufacturing, healthcare, biotechnology, and life sciences.

Our services are fully compliant with MHRA, FDA, EU GMP, and WHO guidelines, and are essential for ensuring that critical spaces and storage facilities maintain consistent, validated conditions for product integrity, regulatory compliance, and audit readiness.

Whether for a new installation or requalification of existing systems, we deliver independent, evidence-based assessments with precise documentation tailored for inspection.

What Is Temperature Mapping?

Temperature mapping is the systematic measurement and analysis of temperature (and optionally humidity) within a controlled environment over time. It ensures that every area of a cold room, chamber, warehouse or transport unit remains within the specified limits under operational conditions.

• Typical environments requiring mapping include:
• Pharmaceutical cold rooms and freezer rooms
• Vaccine storage areas
• Stability and quarantine chambers
• Ambient storage warehouses
• Medical refrigeration units
• Transport containers and mobile units
• Cleanrooms and production areas

Mapping is required for initial qualification, periodic requalification, or following significant changes (e.g. equipment replacement, layout changes or regulatory findings).

What We Deliver

Our mapping and validation process includes:

Site assessment and equipment review

Risk-based sensor placement strategy

Use of high-accuracy calibrated data loggers

Monitoring over defined periods (typically 24–72 hours)

Door-open, power-failure and load simulation testing

Data analysis to identify hot/cold zones or excursions

Detailed mapping report with graphical and tabular outputs

Corrective action support if required

Certificate of compliance and audit-ready documentation

All testing is conducted to GDP, GMP and USP <1079> / <1118> guidelines, using UKAS-calibrated equipment and standardised protocols.

Environments We Map

Our engineers are experienced in mapping:

+2°C to +8°C pharmaceutical cold rooms

-20°C freezers and ultra-low temperature (ULT) rooms

Ambient warehouses (15°C–25°C) with large volume airflow

Controlled environments with humidity (e.g. 25°C / 60% RH)

Refrigerated vehicles, transit boxes and passive systems

Medical fridges, blood banks, vaccine hubs

Cleanrooms and sterile storage areas

Whether you're mapping a 100,000 sq. ft facility or a small clinical-grade fridge, we scale the process accordingly and ensure full compliance and traceability.

Validation Documentation & Regulatory Readiness

Every temperature mapping engagement includes full documentation, developed in alignment with EU GMP Annex 15, FDA CFR 21 Part 11, and WHO Technical Report Series 961.

Your documentation pack includes:

• Mapping protocol (approved in advance by client QA)
• Calibrated equipment list and certificates
• Site plan and sensor positioning logic
• Raw data sets and summary statistics
• Maximum and minimum deviations
• Thermal stratification analysis (if required)
• Exception reporting and root cause evaluation
• Certificate of conformance and compliance sign-off

We also support OQ/PQ protocols where mapping forms part of a broader qualification package for a new or refurbished environment.

Supporting GMP, GDP and ISO Facilities

We provide mapping and validation services to a wide range of regulated environments including:

• GMP manufacturing sites
• Contract manufacturing organisations (CMOs/CDMOs)
• Clinical trial logistics hubs
• NHS and private hospitals
• Vaccine distribution centres
• Life science R&D labs
• Blood and tissue storage facilities
• Veterinary pharmaceutical suppliers

With our deep understanding of compliance, we work closely with your QA, validation and facilities teams to align testing with SOPs and internal risk policies.

Periodic Requalification & Remapping

Temperature-controlled environments must be periodically requalified – typically every 12–24 months, or after significant change.

We offer scheduled requalification services with automated reminders, and can support gap remediation, corrective mapping, and audit preparation where non-conformities have been raised.

All work is conducted by our own highly experienced validation engineers, many of whom have backgrounds in GxP facility design, commissioning, and inspection preparation.

UK & Western Europe Coverage

Operating from our UK headquarters, we deliver mapping and validation services across the UK and Western Europe, including Ireland, Germany, France, the Netherlands, Belgium, and Spain. Our cross-border delivery model ensures regulatory alignment across multiple jurisdictions and centralised document control for multi-site operations.

Book a Mapping Assessment or Validation Survey

Whether you need a new qualification, revalidation, or support following an audit, our team can help.