Equipment Qualification

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

Why This Service Matters

Equipment qualification is crucial because it ensures the equipment reliably and accurately performs its intended function, which is essential for producing valid data. This process provides documented proof that the instrument is suitable for use, maintains data integrity, ensures product safety, and is necessary for complying with regulatory requirements in many different industries like pharmaceuticals

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 Qualification
Periodic Requalification
Change Control Validation
Regulatory Compliance
Quality Assurance Programs

Equipment We Qualify

Laminar Flow Cabinets - Sterile work environments
Air Showers - Personnel decontamination
Isolators - High-level containment systems
Thermostatic Chambers - Temperature control
Dry Sterilizers - Dry heat sterilization
Depyrogenation Tunnels - Endotoxin removal
Microbiological Safety Cabinets - Containment systems
Filter Fan Units - Air filtration systems
Stability Chambers - Environmental testing

Fridges, Freezers, Deep Freezers - Cold storage
Ethylene Oxide (EtO) Sterilizers - Gas sterilization
Pasteurization Tunnels - Heat treatment
Weighing Stations - Precision measurement areas
Fume Cupboards - Chemical containment
Climatic Chamber - Temperature/humidity control
Steam Sterilizers (Autoclaves) - Steam sterilization
Freeze Dryers (Lyophilizers) - Freeze drying process
Other Process & Laboratory Equipment - Custom applications