Validation & Mapping
Ensuring compliance with rigorous IQ, OQ, PQ protocols for your most critical environments.
HVAC Validation
Validation of clean rooms and HVAC systems as per ISO 14644 and EU-GMP requirements to ensure controlled environmental conditions and regulatory compliance.
- Air Velocity & ACPH Testing
- HEPA Filter Integrity Testing (PAO)
- Non-Viable Particle Count Testing
- Recovery Time Studies
- Airflow Visualization (Smoke Study)
- Sound Level Testing
- Light Intensity Measurement
- Temperature & RH Monitoring
Thermal Validation
Temperature distribution and heat penetration studies for pharmaceutical equipment as per WHO, ISPE, ISO 17665, EN285 and CQI-9 guidelines.
- Autoclaves & Steam Sterilizers
- Dry Heat Sterilizers & Depyrogenation Tunnels
- Lyophilizers & Hot Air Ovens
- Incubators & Stability Chambers
- Cold Rooms & Deep Freezers
- Heat Distribution Studies
- Heat Penetration Studies
- Power Failure Studies
Compressed Air & Nitrogen Validation
Validation of compressed air and nitrogen systems according to ISO 8573 and EU/BPSU guidelines to verify purity, moisture control and product safety.
- Dew Point Testing
- Non-Viable Particle Count Testing
- Carbon Dioxide Content Testing
- Nitrogen Dioxide Content Testing
- Sulfur Dioxide Content Testing
- Oxygen Content Testing
- Carbon Monoxide Content Testing
- Oil Mist & Moisture Testing
Validation Protocols Covered
IQ
Installation
OQ
Operational
PQ
Performance