Equipment Qualification

Equipment Qualification

Validation of critical pharmaceutical equipment

Documented process that ensures equipment in regulated industries operates correctly and consistently, meeting predefined standards and requirements for pharmaceutical manufacturing.

Why This Service Matters

All equipment used in critical activities must be initially qualified, then periodically requalified (e.g., annually) to ensure continued compliance and optimal performance.

Parameters Tested
Installation Qualification (IQ) - Verifying proper installation
Operational Qualification (OQ) - Testing operational parameters
Performance Qualification (PQ) - Validating performance under actual conditions
Calibration Verification - Ensuring measurement accuracy
Safety System Testing - Verifying protective mechanisms
Documentation Review - Compliance with specifications
Applications
Initial Equipment QualificationPeriodic RequalificationChange Control ValidationRegulatory ComplianceQuality Assurance Programs

Equipment We Qualify

Laminar Flow Cabinets - Sterile work environments

Microbiological Safety Cabinets - Containment systems

Weighing Stations - Precision measurement areas

Air Showers - Personnel decontamination

Filter Fan Units - Air filtration systems

Fume Cupboards - Chemical containment

Isolators - High-level containment systems

Stability Chambers - Environmental testing

Climatic Chambers - Temperature/humidity control

Thermostatic Chambers - Temperature control

Fridges, Freezers, Deep Freezers - Cold storage

Steam Sterilizers (Autoclaves) - Steam sterilization

Dry Sterilizers - Dry heat sterilization

Ethylene Oxide (EtO) Sterilizers - Gas sterilization

Freeze Dryers (Lyophilizers) - Freeze drying process

Depyrogenation Tunnels - Endotoxin removal

Pasteurization Tunnels - Heat treatment

Other Process & Laboratory Equipment - Custom applications