C&Q Processes, areas and equipment
Area Qualification, Temperature Mapping and FAT/SAT
From the supplier's factory to operation in your plant. We qualify facilities, environments and equipment across the entire cycle: FAT at the supplier's plant, SAT at your site, formal IQ/OQ/PQ and temperature mapping with statistical analysis. One team, full traceability and evidence that stands up to any audit.
Signals
When do you need it?
- You bought critical equipmentAnd you need to verify it before shipment and after installation.
- You're building or renovating a cleanroomISO 14644 classification, differential pressures and monitoring.
- You're commissioning a warehouse or cold roomSummer and winter temperature mapping, loaded and empty.
- Requalification is dueBecause the period expired, the use changed or there was a major intervention.
Approach
A complete cycle, no loose links
The Factory Acceptance Test (FAT) verifies at the supplier's plant that the equipment was built to the URS. The Site Acceptance Test (SAT) confirms it works at your site, with your actual utilities. If the FAT is well documented, part of its evidence can be leveraged in qualification, saving weeks.
For temperature mapping, we define sensor locations, duration and acceptance criteria before measuring. Then we analyze the data by zone, identify hot and cold spots and define where product can and cannot be stored.
Each stage leaves evidence that the next one can leverage. That's why we do them all.
How we do it
Service stages
- FATAt the factoryBuilt to URS/DS, before shipment.
- SATOn siteOperation with actual utilities.
- IQInstallationComponents, connections and documentation.
- OQOperationRanges, alarms and critical functions.
- PQPerformanceReal production conditions.
Regulatory framework
What the regulations require, point by point.
These are the references we work with for this service. We apply the ones that fit your market and your type of product.
ISO Cleanrooms
- ISO 14644-1:2015Classification of air cleanliness by particle concentration.
- ISO 14644-2:2015Monitoring to provide evidence of cleanroom performance.
- ISO 14644-3:2019Test methods.
EU GMP EudraLex Volume 4
- Annex 1 (2022)Manufacture of sterile products: grades A/B/C/D, at rest and in operation, and contamination control strategy.
- Annex 15 (2015)Qualification and validation: URS, FAT/SAT, IQ, OQ, PQ and requalification.
Mapping Storage and distribution
- WHO TRS 961, Annex 9Model guidance for the storage and transport of time- and temperature-sensitive products, with its technical supplement on mapping.
- USP <1079>Good storage and distribution practices.
- EU GDP (2013/C 343/01)Good distribution practice: mapping of storage areas.
FDA and ISPE Technical references
- FDA Aseptic Processing Guidance (2004)Sterile drug products produced by aseptic processing.
- ISPE Baseline Guide Vol. 5Commissioning & Qualification.
- 21 CFR 211.63 and 211.68Equipment design and automatic equipment.
Deliverables
What you get.
Inspection-ready documentation, fully traceable and in your format. And a team trained to maintain it.
- Qualification Plan / VMPScope, strategy, responsibilities and schedule.
- FAT protocol and executionTesting at the supplier's plant with recorded observations.
- SAT protocol and executionOn-site verification with actual utilities.
- IQ / OQ / PQ protocolsFormal qualification with acceptance criteria.
- Temperature mapping protocolSensor layout, duration, scenarios and criteria.
- Statistical analysis of mapping dataMinimums, maximums, means by zone, and hot and cold spots.
- Qualification reports by stageFormal conclusion and release of each phase.
- Traceability matrixEvery URS requirement linked to its verification.
FAQ
What clients ask before we start
Does the FAT replace the SAT?
No. Site conditions are different (utilities, environment, real loads). What you can do is leverage FAT evidence to reduce repeated testing.
How long does temperature mapping take?
It depends on the space and the risk. Typically it covers extreme summer and winter conditions, loaded and empty. The protocol justifies the duration.
Are the data loggers calibrated?
Yes. We use equipment with calibration certificates traceable to national and international standards, and the reports include them.
Works well with
Related services
-
PV
Process validation
Manufacturing processes that must demonstrate consistent results, batch after batch.- FDA PV Guidance 2011
- EU GMP Annex 15
- ICH Q9(R1)
-
CSV
System validation (CSV)
LIMS, ERP, MES, SCADA or QMS that must prove they do what they claim.- GAMP 5 Second Edition
- 21 CFR Part 11
- EU GMP Annex 11
-
SOP
SOP development
SOPs written for compliance that nobody reads, understands or follows.- 21 CFR 211.100
- EU GMP Chapter 4
- ICH Q10
Next step
Be ready for your next
regulatory challenge.
Tell us what you need to validate, qualify or document. In the first conversation we get to know your operation and tell you how we would approach it.