Validation & Calibration Services for Regulated Environments
Your cleanroom is only as compliant as your validation documentation. Our validation and calibration specialists ensure your facility, systems, and instruments meet regulatory requirements — and that you can prove it.
Africa Cleanroom Laboratory Solutions provides comprehensive IQ/OQ/PQ validation services and SANAS-supported calibration for cleanrooms, HVAC systems, laboratory equipment, and measuring instruments across Africa.
Validation That Stands Up to Inspection
Our validation team brings deep experience in pharmaceutical GMP requirements, SAHPRA regulatory frameworks, ISO 14644 standards, and laboratory quality systems.
Evidence, Not Assumptions
We produce validation packages that give your quality team confidence and provide documented evidence that systems consistently perform within specification.
Installation Qualification — IQ
Verification that your cleanroom, HVAC system, or laboratory equipment has been installed correctly and in accordance with approved specifications.
Operational Qualification — OQ
Verification that your installed system operates consistently within defined parameters across its full operating range, including worst-case conditions.
Performance Qualification — PQ
Verification that your system consistently performs in accordance with defined specifications under actual or simulated production conditions.
Cleanroom Classification Testing
ISO 14644-1 particle count testing and cleanroom classification verification — performed at rest and in operation — with full documentation.
HVAC Commissioning & Qualification
Air change rate verification, filter integrity testing, pressure differential measurement, temperature and humidity mapping, and smoke visualisation studies.
Calibration Documentation
Full calibration certificates with measurement uncertainty statements, traceability references, and calibration schedules compliant with ISO 17025 and GMP documentation requirements.
Laboratory Instrument Calibration
Calibration of balances, pH meters, spectrophotometers, temperature measuring devices, pressure gauges, and general laboratory instrumentation — traceable to national measurement standards.
HVAC Instrument Calibration
Calibration of temperature sensors, humidity transmitters, pressure transducers, airflow measurement devices, and environmental monitoring instruments used in cleanroom and HVAC systems.
Documented Compliance for Critical Systems
Validation is not a box-ticking exercise. It is the documented proof that your cleanroom, HVAC system, and instruments meet the standard your operation and regulator require.
