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.

We have well documented systems & SOPs for various stages of the projects – design, engineering, Installation, FQPs etc. to take care of stringent documentation needs also – Design Qualification (DQ), Installation Qualification (IQ), Operation Qualification (OQ), Performance Qualification (PQ), systematically & logically. Our in-house dedicated well-equipped teams take care of validation services as per ISO 14644 or other relevant standards to meet the regulatory needs of USFDA or UKMHRA or MCC or as the case may be.

Clean room Validation Tests include -

  • Air Flow Pattern
  • Air Flow Velocity and Changes Per Hour
  • Filter Integrity Test
  • Particle Count
  • Viable Monitoring
  • Recovery
  • Temperature & Humidity Test
  • Pressure Difference
  • Light Intensity
  • Noise
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