Area Qualification, Thermal Mapping and FAT/SAT
From the supplier's factory to operation at your plant. We qualify facilities, environments and equipment with documentary evidence that withstands any audit.
Beyond regulatory compliance
Cleanroom qualification, thermal mapping and FAT/SAT acceptance testing are fundamental pillars of pharmaceutical manufacturing. Without rigorous qualification, the environmental conditions that guarantee product quality remain undemonstrated — and that is exactly what inspectors look for.
At DRP Assurance we execute the entire qualification cycle: from FAT at the supplier's plant, through on-site SAT, to full IQ/OQ/PQ qualification of areas and thermal mapping, under ISO 14644, EU GMP Annex 1, WHO TRS and FDA regulations.
Key Benefits
Cleanroom qualification
Particle classification, CFU counting, pressure differentials per ISO 14644 and EU GMP Annex 1.
Complete thermal mapping
WHO TRS 1010 protocols, sensor distribution, statistical analysis, hot/cold spot identification.
FAT at supplier's plant
We verify that the equipment was built according to URS/DS before shipping, reducing post-installation risks.
SAT at client site
We confirm that the equipment works correctly in its real environment with all utility connections.
IQ/OQ/PQ cycle
Formal installation, operation and performance qualification with rigorous acceptance criteria.
Periodic requalification
Continuous monitoring programs and requalification per ISO 14644-2 and regulatory requirements.
Our Process
Assessment and planning
We analyze equipment/area requirements and design the Validation Master Plan.
FAT (Factory Acceptance Test)
We execute tests at the supplier's plant verifying compliance with specifications.
SAT (Site Acceptance Test)
We verify on-site operation with actual utility connections.
IQ/OQ/PQ qualification
Formal installation, operation and performance protocols with documented evidence.
Thermal mapping and release
Mapping execution, statistical analysis and final qualification report.
Service Features
Regulatory Framework
- ISO 14644-1/2/3 — Cleanrooms
- EU GMP Annex 1 (2022) — Sterile products
- EU GMP Annex 15 — Qualification and Validation
- WHO TRS 1010 Annex 5 — Thermal mapping
- FDA Aseptic Processing (2004)
- ISPE GAMP 5 / Baseline Vol. 5
Deliverables
- Qualification Plan / VMP
- FAT Protocol + execution
- SAT Protocol + execution
- IQ/OQ/PQ Protocols
- Thermal Mapping Protocol + analysis
- Qualification Reports per stage
Why choose DRP for Area Qualification and FAT/SAT?
Complete FAT to SAT to IQ to OQ to PQ coverage
We don't subcontract stages. A single team executes the entire cycle with complete traceability.
Own calibrated equipment
Dataloggers and sensors with calibration certificates traceable to national and international standards.
Annex 1 (2022) expertise
We have in-depth knowledge of the latest Annex 1 revision, the most demanding in regulatory history for sterile products.
Is your plant ready for an inspection?
Ensure that your areas, equipment and HVAC systems meet the most demanding standards.
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