Gap Analysis and ValidationServices
The Risk of Regulatory Non Compliance is greatly reduced if a good validation system is in place
Validation is the process of establishing documentary evidence demonstrating that a procedure, process, or activity carried out in testing and then production maintains the desired level of compliance at all stages thereby ensuring product quality at all times. In the pharmaceutical industry, it is very important that in addition to final testing and compliance of products, it is also assured that the process will consistently produce the expected results.
Multi System Validation Services
HVAX is a global player for validation services. Our Experienced team carries out cleanroom validation services using calibrated sophisticated equipment. The reports generated are in appropriate formats thus very clearly giving an idea to client on non-compliances, if any, considering the global acceptable standards.
We Validate and Qualify every system that's a part of our Turnkey offering. From Sampling zones to Warehouses. Clean rooms - HVAC, Direct air flow zones, Laminar Equipment, Stability chambers and Cold-rooms are validated.
Clean Room Validation Package
Clean room Validation Tests include:
- Air flow pattern
- Air flow velocity and changes per hour
- Filter leak test
- Particle count
- Viable monitoring
- Filter integrity test
- Fresh air determination
- Temperature and humidity uniformity test
- Pressure difference
- HEPA Integrity Test
- Differential Pressure Tests
- Blow Down Clean up and Recovery
- Light Intensity
- Temperature and RH Mapping