CALIBRATION REPAIR MAINTENANCE

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

Compressed air quality is critical as contaminated air can directly impact product quality and patient safety. Regular qualification ensures compliance with required purity classes.

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 Chambers - Temperature/humidity control

• Steam Sterilizers (Autoclaves) - Steam sterilization

• Freeze Dryers (Lyophilizers) - Freeze drying process

• Other Process & Laboratory Equipment - Custom applications