KSA Industry Standard
Pharmaceutical & Biotech
Sector Metrology Profile
FDA 21 CFR Part 11 and SFDA compliant thermal mapping, validation, and instrument calibration for cleanroom environments.
Key Compliance Highlights
FDA 21 CFR Part 11 audit trails
Cleanroom thermal mappings
Ultra-low temperature storage check
Regulatory Frameworks
FDA 21 CFR Part 11
ISPE GAMP 5
SFDA Drug Guidelines
Recommended Calibration Services
Temperature Calibration
Accredited thermal calibration ranging from -80°C to 1200°C. We ensure accuracy for heat treatment ovens and vaccine cold chains.
Mass Calibration
Accredited mass verification for OIML standard weights and laboratory weighing balances to ensure absolute recipe formulations.
Chemical Instruments
Accredited chemical verification for liquid analysis systems. We calibrate pH meters, conductivity meters, and water quality analyzers using certified reference materials (CRM).
Equipment Validation
Thermal mapping, validation, and qualification (IQ/OQ/PQ) for critical cleanrooms, warehouses, autoclaves, and freeze dryers.